Autologous Fat Grafting for the Treatment of Chronic Tendinopathy

• Adipose Stem/Stromal Cells for Enthesis/Tendon Therapy (ASSET) Injection (Procedure): ASSET i.e., mechanically concentrated autologous lipoaspirate, prepared and delivered in a single, same-day, point-of-care procedure. Under local anesthesia, 5-15 cc of subcutaneous abdominal fat is harvested by small-volume manual liposuction. The lipoaspirate is sterilely rinsed and concentrated by manual rolling on a non-adherent (Telfa) dressing; no enzymatic (collagenase) digestion, cell isolation, culture, or expansion is performed (minimal manipulation). Under ultrasound guidance, percutaneous tenotomy (needle fenestration) of the target tendon is performed, followed by a single intratendinous injection of 1-3 cc of the concentrated graft into the area of tendinopathy. One-time administration; route is percutaneous intratendinous injection. No exogenous cells, additives, scaffolds, or culture are used; the graft is autologous and delivered within the same surgical procedure.

Primary outcomes

• Change From Baseline in Patient-Reported Pain Intensity (Numeric Rating Scale, NRS) at 6 Months [Baseline (pre-procedure) and Month 6]: Pain in the affected tendon is self-reported on the 11-point Numeric Rating Scale (NRS), an integer from 0 to 10 where 0 = no pain and 10 = worst pain imaginable. The outcome is the mean change from baseline (pre-procedure) to Month 6, calculated as the Month 6 score minus the baseline score. A negative change indicates improvement; a lower score is a better outcome.

Secondary outcomes

• Change From Baseline in Patient-Reported Pain (NRS) at Week 6 [Baseline, Week 6]: Onset and durability of pain relief are assessed using the same 0-10 Numeric Rating Scale (NRS; 0 = no pain, 10 = worst pain imaginable) at the non-primary time point. The outcome is the mean change from baseline at Week 6. (score minus baseline score). A negative change indicates improvement; a lower score is a better outcome.
• Change From Baseline in Patient-Reported Pain (NRS) at Month 3 [Baseline, Month 3]: Onset and durability of pain relief are assessed using the same 0-10 Numeric Rating Scale (NRS; 0 = no pain, 10 = worst pain imaginable) at the non-primary time point. The outcome is the mean change from baseline at Month 3 (score minus baseline score). A negative change indicates improvement; a lower score is a better outcome.
• Change From Baseline in Patient-Reported Pain (NRS) at Month 12 [Baseline, Month 12]: Onset and durability of pain relief are assessed using the same 0-10 Numeric Rating Scale (NRS; 0 = no pain, 10 = worst pain imaginable) at the non-primary time point. The outcome is the mean change from baseline at Month 12 (score minus baseline score). A negative change indicates improvement; a lower score is a better outcome.
• Mean Change From Baseline in LEFS at Week 6 [Baseline - Week 6]: The Lower Extremity Functional Scale (LEFS) is a 20-item patient-reported instrument scored 0-80, where higher scores indicate better lower-extremity function. It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Week 6; a positive change indicates improvement.
• Mean Change From Baseline in LEFS at Month 3 [Baseline - Month 3]: The Lower Extremity Functional Scale (LEFS) is a 20-item patient-reported instrument scored 0-80, where higher scores indicate better lower-extremity function. It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 3; a positive change indicates improvement.
• Mean Change From Baseline in LEFS at Month 6 [Baseline - Month 6]: The Lower Extremity Functional Scale (LEFS) is a 20-item patient-reported instrument scored 0-80, where higher scores indicate better lower-extremity function. It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 6; a positive change indicates improvement.
• Mean Change From Baseline in LEFS at Month 12 [Baseline - Month 12]: The Lower Extremity Functional Scale (LEFS) is a 20-item patient-reported instrument scored 0-80, where higher scores indicate better lower-extremity function. It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 12; a positive change indicates improvement.
• Mean Change From Baseline in HOOS Pain Subscale at Week 6 [Baseline - Week 6]: The Hip Disability and Osteoarthritis Outcome Score (HOOS), Pain subscale, is scored 0-100, where higher scores indicate a better outcome (less pain). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Week 6; a positive change indicates improvement.
• Mean Change From Baseline in HOOS Pain Subscale at Month 3 [Baseline - Month 3]: The Hip Disability and Osteoarthritis Outcome Score (HOOS), Pain subscale, is scored 0-100, where higher scores indicate a better outcome (less pain). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 3; a positive change indicates improvement.
• Mean Change From Baseline in HOOS Pain Subscale at Month 6 [Baseline - Month 6]: The Hip Disability and Osteoarthritis Outcome Score (HOOS), Pain subscale, is scored 0-100, where higher scores indicate a better outcome (less pain). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 6; a positive change indicates improvement.
• Mean Change From Baseline in HOOS Pain Subscale at Month 12 [Baseline - Month 12]: The Hip Disability and Osteoarthritis Outcome Score (HOOS), Pain subscale, is scored 0-100, where higher scores indicate a better outcome (less pain). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 12; a positive change indicates improvement.
• Mean Change From Baseline in HOOS Symptoms Subscale at Week 6 [Baseline - Week 6]: The Hip Disability and Osteoarthritis Outcome Score (HOOS), Symptoms subscale, is scored 0-100, where higher scores indicate a better outcome (fewer symptoms, including stiffness). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Week 6; a positive change indicates improvement.
• Mean Change From Baseline in HOOS Symptoms Subscale at Month 3 [Baseline - Month 3]: The Hip Disability and Osteoarthritis Outcome Score (HOOS), Symptoms subscale, is scored 0-100, where higher scores indicate a better outcome (fewer symptoms, including stiffness). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 3; a positive change indicates improvement.
• Mean Change From Baseline in HOOS Symptoms Subscale at Month 6 [Baseline - Month 6]: The Hip Disability and Osteoarthritis Outcome Score (HOOS), Symptoms subscale, is scored 0-100, where higher scores indicate a better outcome (fewer symptoms, including stiffness). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 6; a positive change indicates improvement.
• Mean Change From Baseline in HOOS Symptoms Subscale at Month 12 [Baseline - Month 12]: The Hip Disability and Osteoarthritis Outcome Score (HOOS), Symptoms subscale, is scored 0-100, where higher scores indicate a better outcome (fewer symptoms, including stiffness). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 12; a positive change indicates improvement.
• Mean Change From Baseline in HOOS ADL (Function in Daily Living) Subscale at Week 6 [Baseline - Week 6]: The Hip Disability and Osteoarthritis Outcome Score (HOOS), Function in Daily Living (ADL) subscale, is scored 0-100, where higher scores indicate a better outcome (less difficulty with daily activities). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Week 6; a positive change indicates improvement.
• Mean Change From Baseline in HOOS ADL (Function in Daily Living) Subscale at Month 3 [Baseline - Month 3]: The Hip Disability and Osteoarthritis Outcome Score (HOOS), Function in Daily Living (ADL) subscale, is scored 0-100, where higher scores indicate a better outcome (less difficulty with daily activities). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 3; a positive change indicates improvement.
• Mean Change From Baseline in HOOS ADL (Function in Daily Living) Subscale at Month 6 [Baseline - Month 6]: The Hip Disability and Osteoarthritis Outcome Score (HOOS), Function in Daily Living (ADL) subscale, is scored 0-100, where higher scores indicate a better outcome (less difficulty with daily activities). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 6; a positive change indicates improvement.
• Mean Change From Baseline in HOOS ADL (Function in Daily Living) Subscale at Month 12 [Baseline - Month 12]: The Hip Disability and Osteoarthritis Outcome Score (HOOS), Function in Daily Living (ADL) subscale, is scored 0-100, where higher scores indicate a better outcome (less difficulty with daily activities). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 12; a positive change indicates improvement.
• Mean Change From Baseline in HOOS Sport/Recreation Subscale at Week 6 [Baseline - Week 6]: The Hip Disability and Osteoarthritis Outcome Score (HOOS), Function in Sport and Recreation subscale, is scored 0-100, where higher scores indicate a better outcome (less difficulty with sport and recreational activities). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Week 6; a positive change indicates improvement.
• Mean Change From Baseline in HOOS Sport/Recreation Subscale at Month 3 [Baseline - Month 3]: The Hip Disability and Osteoarthritis Outcome Score (HOOS), Function in Sport and Recreation subscale, is scored 0-100, where higher scores indicate a better outcome (less difficulty with sport and recreational activities). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 3; a positive change indicates improvement.
• Mean Change From Baseline in HOOS Sport/Recreation Subscale at Month 6 [Baseline - Month 6]: The Hip Disability and Osteoarthritis Outcome Score (HOOS), Function in Sport and Recreation subscale, is scored 0-100, where higher scores indicate a better outcome (less difficulty with sport and recreational activities). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 6; a positive change indicates improvement.
• Mean Change From Baseline in HOOS Sport/Recreation Subscale at Month 12 [Baseline - Month 12]: The Hip Disability and Osteoarthritis Outcome Score (HOOS), Function in Sport and Recreation subscale, is scored 0-100, where higher scores indicate a better outcome (less difficulty with sport and recreational activities). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 12; a positive change indicates improvement.
• Mean Change From Baseline in HOOS Quality of Life Subscale at Week 6 [Baseline - Week 6]: The Hip Disability and Osteoarthritis Outcome Score (HOOS), Hip-Related Quality of Life subscale, is scored 0-100, where higher scores indicate a better outcome (better hip-related quality of life). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Week 6; a positive change indicates improvement.
• Mean Change From Baseline in HOOS Quality of Life Subscale at Month 3 [Baseline - Month 3]: The Hip Disability and Osteoarthritis Outcome Score (HOOS), Hip-Related Quality of Life subscale, is scored 0-100, where higher scores indicate a better outcome (better hip-related quality of life). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 3; a positive change indicates improvement.
• Mean Change From Baseline in HOOS Quality of Life Subscale at Month 6 [Baseline - Month 6]: The Hip Disability and Osteoarthritis Outcome Score (HOOS), Hip-Related Quality of Life subscale, is scored 0-100, where higher scores indicate a better outcome (better hip-related quality of life). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 6; a positive change indicates improvement.
• Mean Change From Baseline in HOOS Quality of Life Subscale at Month 12 [Baseline - Month 12]: The Hip Disability and Osteoarthritis Outcome Score (HOOS), Hip-Related Quality of Life subscale, is scored 0-100, where higher scores indicate a better outcome (better hip-related quality of life). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 12; a positive change indicates improvement.
• Mean Change From Baseline in DASH at Week 6 [Baseline - Week 6]: The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is scored 0-100, where higher scores indicate greater disability (worse function). It is administered only to participants whose treated tendinopathy is in the hand/wrist; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Week 6; a negative change indicates improvement.
• Mean Change From Baseline in DASH at Month 3 [Baseline - Month 3]: The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is scored 0-100, where higher scores indicate greater disability (worse function). It is administered only to participants whose treated tendinopathy is in the hand/wrist; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 3; a negative change indicates improvement.
• Mean Change From Baseline in DASH at Month 6 [Baseline - Month 6]: The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is scored 0-100, where higher scores indicate greater disability (worse function). It is administered only to participants whose treated tendinopathy is in the hand/wrist; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 6; a negative change indicates improvement.
• Mean Change From Baseline in DASH at Month 12 [Baseline - Month 12]: The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is scored 0-100, where higher scores indicate greater disability (worse function). It is administered only to participants whose treated tendinopathy is in the hand/wrist; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 12; a negative change indicates improvement.
• Mean Change From Baseline in MEPI at Week 6 [Baseline - Week 6]: The Mayo Elbow Performance Index (MEPI) is scored 0-100, where higher scores indicate better elbow function. It is administered only to participants whose treated tendinopathy is at the elbow; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Week 6; a positive change indicates improvement.
• Mean Change From Baseline in MEPI at Month 3 [Baseline - Month 3]: The Mayo Elbow Performance Index (MEPI) is scored 0-100, where higher scores indicate better elbow function. It is administered only to participants whose treated tendinopathy is at the elbow; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 3; a positive change indicates improvement.
• Mean Change From Baseline in MEPI at Month 6 [Baseline - Month 6]: The Mayo Elbow Performance Index (MEPI) is scored 0-100, where higher scores indicate better elbow function. It is administered only to participants whose treated tendinopathy is at the elbow; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 6; a positive change indicates improvement.
• Mean Change From Baseline in MEPI at Month 12 [Baseline - Month 12]: The Mayo Elbow Performance Index (MEPI) is scored 0-100, where higher scores indicate better elbow function. It is administered only to participants whose treated tendinopathy is at the elbow; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 12; a positive change indicates improvement.
• Mean Change From Baseline in VISA-A at Week 6 [Baseline - Week 6]: The Victorian Institute of Sport Assessment-Achilles (VISA-A) is scored 0-100, where higher scores indicate better (less symptomatic) tendon function. It is administered only to participants whose treated tendinopathy is at the Achilles tendon; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Week 6; a positive change indicates improvement.
• Mean Change From Baseline in VISA-A at Month 3 [Baseline - Month 3]: The Victorian Institute of Sport Assessment-Achilles (VISA-A) is scored 0-100, where higher scores indicate better (less symptomatic) tendon function. It is administered only to participants whose treated tendinopathy is at the Achilles tendon; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 3; a positive change indicates improvement.
• Mean Change From Baseline in VISA-A at Month 6 [Baseline - Month 6]: The Victorian Institute of Sport Assessment-Achilles (VISA-A) is scored 0-100, where higher scores indicate better (less symptomatic) tendon function. It is administered only to participants whose treated tendinopathy is at the Achilles tendon; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 6; a positive change indicates improvement.
• Mean Change From Baseline in VISA-A at Month 12 [Baseline - Month 12]: The Victorian Institute of Sport Assessment-Achilles (VISA-A) is scored 0-100, where higher scores indicate better (less symptomatic) tendon function. It is administered only to participants whose treated tendinopathy is at the Achilles tendon; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 12; a positive change indicates improvement.
• Tendon Architecture Assessment: Mean Change From Baseline in Tendon Thickness at Week 6 [Baseline - Week 6]: Maximal anteroposterior thickness of the treated tendon, measured on grayscale B-mode ultrasound at the site of maximal pathology and reported in millimeters. Tendinopathy is characterized by tendon thickening, so the outcome is the mean change from baseline to Week 6; a negative change (reduction in thickness toward normal) indicates improvement.
• Tendon Architecture Assessment: Mean Change From Baseline in Tendon Thickness at Month 3 [Baseline - Month 3]: Maximal anteroposterior thickness of the treated tendon, measured on grayscale B-mode ultrasound at the site of maximal pathology and reported in millimeters. Tendinopathy is characterized by tendon thickening, so the outcome is the mean change from baseline to Month 3; a negative change (reduction in thickness toward normal) indicates improvement.
• Tendon Architecture Assessment: Mean Change From Baseline in Tendon Thickness at Month 6 [Baseline - Month 6]: Maximal anteroposterior thickness of the treated tendon, measured on grayscale B-mode ultrasound at the site of maximal pathology and reported in millimeters. Tendinopathy is characterized by tendon thickening, so the outcome is the mean change from baseline to Month 6; a negative change (reduction in thickness toward normal) indicates improvement.
• Tendon Architecture Assessment: Mean Change From Baseline in Tendon Thickness at Month 12 [Baseline - Month 12]: Maximal anteroposterior thickness of the treated tendon, measured on grayscale B-mode ultrasound at the site of maximal pathology and reported in millimeters. Tendinopathy is characterized by tendon thickening, so the outcome is the mean change from baseline to Month 12; a negative change (reduction in thickness toward normal) indicates improvement.
• Tendon Architecture Assessment: Mean Change From Baseline in Fibrillar Structure Grade at Week 6 [Baseline - Week 6]: Tendon fibrillar architecture graded by a blinded reviewer on a 4-point ordinal scale (0-3) adapted from the modified Öhberg structural score, where 0 = normal, uniformly fibrillar echotexture and 3 = severe loss of the fibrillar pattern with extensive structural disorganization. The outcome is the mean change from baseline to Week 6; a negative change (a lower score, indicating more normal architecture) indicates improvement.
• Tendon Architecture Assessment: Mean Change From Baseline in Fibrillar Structure Grade at Month 3 [Baseline - Month 3]: Tendon fibrillar architecture graded by a blinded reviewer on a 4-point ordinal scale (0-3) adapted from the modified Öhberg structural score, where 0 = normal, uniformly fibrillar echotexture and 3 = severe loss of the fibrillar pattern with extensive structural disorganization. The outcome is the mean change from baseline to Month 3; a negative change (a lower score, indicating more normal architecture) indicates improvement.
• Tendon Architecture Assessment: Mean Change From Baseline in Fibrillar Structure Grade at Month 6 [Baseline - Month 6]: Tendon fibrillar architecture graded by a blinded reviewer on a 4-point ordinal scale (0-3) adapted from the modified Öhberg structural score, where 0 = normal, uniformly fibrillar echotexture and 3 = severe loss of the fibrillar pattern with extensive structural disorganization. The outcome is the mean change from baseline to Month 6; a negative change (a lower score, indicating more normal architecture) indicates improvement.
• Tendon Architecture Assessment: Mean Change From Baseline in Fibrillar Structure Grade at Month 12 [Baseline - Month 12]: Tendon fibrillar architecture graded by a blinded reviewer on a 4-point ordinal scale (0-3) adapted from the modified Öhberg structural score, where 0 = normal, uniformly fibrillar echotexture and 3 = severe loss of the fibrillar pattern with extensive structural disorganization. The outcome is the mean change from baseline to Month 12; a negative change (a lower score, indicating more normal architecture) indicates improvement.
• Tendon Architecture Assessment: Mean Change From Baseline in Hypoechogenicity Grade at Week 6 [Baseline - Week 6]: Intratendinous hypoechogenicity graded by a blinded reviewer on a 4-point ordinal scale (0-3), where 0 = normal echogenicity and 3 = severe, extensive intratendinous hypoechoic change. The outcome is the mean change from baseline to Week 6; a negative change (a lower score) indicates improvement.
• Tendon Architecture Assessment: Mean Change From Baseline in Hypoechogenicity Grade at Month 3 [Baseline - Month 3]: Intratendinous hypoechogenicity graded by a blinded reviewer on a 4-point ordinal scale (0-3), where 0 = normal echogenicity and 3 = severe, extensive intratendinous hypoechoic change. The outcome is the mean change from baseline to Month 3; a negative change (a lower score) indicates improvement.
• Tendon Architecture Assessment: Mean Change From Baseline in Hypoechogenicity Grade at Month 6 [Baseline - Month 6]: Intratendinous hypoechogenicity graded by a blinded reviewer on a 4-point ordinal scale (0-3), where 0 = normal echogenicity and 3 = severe, extensive intratendinous hypoechoic change. The outcome is the mean change from baseline to Month 6; a negative change (a lower score) indicates improvement.
• Tendon Architecture Assessment: Mean Change From Baseline in Hypoechogenicity Grade at Month 12 [Baseline - Month 12]: Intratendinous hypoechogenicity graded by a blinded reviewer on a 4-point ordinal scale (0-3), where 0 = normal echogenicity and 3 = severe, extensive intratendinous hypoechoic change. The outcome is the mean change from baseline to Month 12; a negative change (a lower score) indicates improvement.
• Tendon Architecture Assessment: Mean Change From Baseline in Neovascularization Grade at Week 6 [Baseline - Week 6]: Intratendinous and peritendinous neovascularity assessed on power-Doppler ultrasound and graded by a blinded reviewer on the modified Öhberg score, a 5-point ordinal scale (0-4) where 0 = no Doppler flow and 4 = extensive flow throughout the tendon. Neovascularization is frequently absent in chronic tendinopathy, so a floor at 0 is expected in many participants. The outcome is the mean change from baseline to Week 6; a negative change (a lower score) indicates improvement.
• Tendon Architecture Assessment: Mean Change From Baseline in Neovascularization Grade at Month 3 [Baseline - Month 3]: Intratendinous and peritendinous neovascularity assessed on power-Doppler ultrasound and graded by a blinded reviewer on the modified Öhberg score, a 5-point ordinal scale (0-4) where 0 = no Doppler flow and 4 = extensive flow throughout the tendon. Neovascularization is frequently absent in chronic tendinopathy, so a floor at 0 is expected in many participants. The outcome is the mean change from baseline to Month 3; a negative change (a lower score) indicates improvement.
• Tendon Architecture Assessment: Mean Change From Baseline in Neovascularization Grade at Month 6 [Baseline - Month 6]: Intratendinous and peritendinous neovascularity assessed on power-Doppler ultrasound and graded by a blinded reviewer on the modified Öhberg score, a 5-point ordinal scale (0-4) where 0 = no Doppler flow and 4 = extensive flow throughout the tendon. Neovascularization is frequently absent in chronic tendinopathy, so a floor at 0 is expected in many participants. The outcome is the mean change from baseline to Month 6; a negative change (a lower score) indicates improvement.
• Tendon Architecture Assessment: Mean Change From Baseline in Neovascularization Grade at Month 12 [Baseline - Month 12]: Intratendinous and peritendinous neovascularity assessed on power-Doppler ultrasound and graded by a blinded reviewer on the modified Öhberg score, a 5-point ordinal scale (0-4) where 0 = no Doppler flow and 4 = extensive flow throughout the tendon. Neovascularization is frequently absent in chronic tendinopathy, so a floor at 0 is expected in many participants. The outcome is the mean change from baseline to Month 12; a negative change (a lower score) indicates improvement.
• Tendon Architecture Assessment: Number of Participants With Intratendinous Calcification at Week 6 [Week 6]: The number of participants in whom one or more intratendinous calcific foci are identified in the treated tendon on grayscale ultrasound at Week 6, reported as a count of participants. Calcification is not expected to resolve over the study period and is reported primarily for structural characterization.
• Tendon Architecture Assessment: Number of Participants With Intratendinous Calcification at Month 3 [Month 3]: The number of participants in whom one or more intratendinous calcific foci are identified in the treated tendon on grayscale ultrasound at Month 3, reported as a count of participants. Calcification is not expected to resolve over the study period and is reported primarily for structural characterization.
• Tendon Architecture Assessment: Number of Participants With Intratendinous Calcification at Month 6 [Month 6]: The number of participants in whom one or more intratendinous calcific foci are identified in the treated tendon on grayscale ultrasound at Month 6, reported as a count of participants. Calcification is not expected to resolve over the study period and is reported primarily for structural characterization.
• Tendon Architecture Assessment: Number of Participants With Intratendinous Calcification at Month 12 [Month 12]: The number of participants in whom one or more intratendinous calcific foci are identified in the treated tendon on grayscale ultrasound at Month 12, reported as a count of participants. Calcification is not expected to resolve over the study period and is reported primarily for structural characterization.
• Tendon Architecture Assessment: Number of Participants With a Tendon Tear at Week 6 [Week 6]: The number of participants in whom a partial-thickness or full-thickness intrasubstance tear of the treated tendon is identified on ultrasound at Week 6, reported as a count of participants. Tear sidedness and thickness are recorded in the source documentation; this measure reports tear presence.
• Tendon Architecture Assessment: Number of Participants With a Tendon Tear at Month 3 [Month 3]: The number of participants in whom a partial-thickness or full-thickness intrasubstance tear of the treated tendon is identified on ultrasound at Month 3, reported as a count of participants. Tear sidedness and thickness are recorded in the source documentation; this measure reports tear presence.
• Tendon Architecture Assessment: Number of Participants With a Tendon Tear at Month 6 [Month 6]: The number of participants in whom a partial-thickness or full-thickness intrasubstance tear of the treated tendon is identified on ultrasound at Month 6, reported as a count of participants. Tear sidedness and thickness are recorded in the source documentation; this measure reports tear presence.
• Tendon Architecture Assessment: Number of Participants With a Tendon Tear at Month 12 [Month 12]: The number of participants in whom a partial-thickness or full-thickness intrasubstance tear of the treated tendon is identified on ultrasound at Month 12, reported as a count of participants. Tear sidedness and thickness are recorded in the source documentation; this measure reports tear presence.
• Tendon Architecture Assessment: Mean Change From Baseline in Maximal Tear Dimension at Week 6 [Baseline - Week 6]: Among participants with a demonstrable tendon tear, the maximal dimension (length) of the tear measured on ultrasound, reported in millimeters. The outcome is the mean change from baseline to Week 6; a negative change (reduction in tear size) indicates improvement. Participants without a tear are handled per the statistical analysis plan.
• Tendon Architecture Assessment: Mean Change From Baseline in Maximal Tear Dimension at Month 3 [Baseline - Month 3]: Among participants with a demonstrable tendon tear, the maximal dimension (length) of the tear measured on ultrasound, reported in millimeters. The outcome is the mean change from baseline to Month 3; a negative change (reduction in tear size) indicates improvement. Participants without a tear are handled per the statistical analysis plan.
• Tendon Architecture Assessment: Mean Change From Baseline in Maximal Tear Dimension at Month 6 [Baseline - Month 6]: Among participants with a demonstrable tendon tear, the maximal dimension (length) of the tear measured on ultrasound, reported in millimeters. The outcome is the mean change from baseline to Month 6; a negative change (reduction in tear size) indicates improvement. Participants without a tear are handled per the statistical analysis plan.
• Tendon Architecture Assessment: Mean Change From Baseline in Maximal Tear Dimension at Month 12 [Baseline - Month 12]: Among participants with a demonstrable tendon tear, the maximal dimension (length) of the tear measured on ultrasound, reported in millimeters. The outcome is the mean change from baseline to Month 12; a negative change (reduction in tear size) indicates improvement. Participants without a tear are handled per the statistical analysis plan.
• Participant Satisfaction (Short Assessment of Patient Satisfaction, SAPS) at Week 6 [Week 6]: Treatment satisfaction is measured with the Short Assessment of Patient Satisfaction (SAPS), a 7-item questionnaire. Each item is scored 0-4 for a total score of 0-28, where higher scores indicate greater satisfaction with treatment.
• Participant Satisfaction (Short Assessment of Patient Satisfaction, SAPS) at Month 3 [Month 3]: Treatment satisfaction is measured with the Short Assessment of Patient Satisfaction (SAPS), a 7-item questionnaire. Each item is scored 0-4 for a total score of 0-28, where higher scores indicate greater satisfaction with treatment.
• Participant Satisfaction (Short Assessment of Patient Satisfaction, SAPS) at Month 6 [Month 6]: Treatment satisfaction is measured with the Short Assessment of Patient Satisfaction (SAPS), a 7-item questionnaire. Each item is scored 0-4 for a total score of 0-28, where higher scores indicate greater satisfaction with treatment.
• Participant Satisfaction (Short Assessment of Patient Satisfaction, SAPS) at Month 12 [Month 12]: Treatment satisfaction is measured with the Short Assessment of Patient Satisfaction (SAPS), a 7-item questionnaire. Each item is scored 0-4 for a total score of 0-28, where higher scores indicate greater satisfaction with treatment.
• Number and Severity of Adverse Events (Safety and Tolerability) [From procedure (Day 0) through Month 12]: Safety is assessed as the number of participants with adverse events (AEs), with AEs tabulated by type, severity (e.g., mild/moderate/severe), seriousness, and attribution/relatedness to the procedure. Harvest (liposuction)-site and injection-site events are captured.

Sex: All, ages: 18 Years to 80 Years

Inclusion Criteria

1. Age 18-80 years.
2. Tendinopathy at any tendon location (e.g., rotator cuff/supraspinatus, lateral epicondyle, gluteal/hip, Achilles, patellar).
3. Confirmed tendon pathology: pain at the tendon site for > 3 months AND pathology confirmed on ultrasound.
4. Failure of conservative treatment (e.g., activity modification, physical therapy, NSAIDs, corticosteroid injection, and/or PRP) for at least 6 weeks.
5. Able to provide informed consent and complete questionnaires in English.

Exclusion Criteria

1. Full-thickness tendon tear.
2. Prior surgery at the target tendon site.
3. Injection or other intervention at the target tendon site within the prior 6 months.
4. Pregnancy or breastfeeding.
5. Active local or systemic infection, bleeding diathesis or anticoagulation precluding the procedure, or other condition that in the investigator's judgment makes participation unsafe.
6. Moderate-to-high-grade arthritis in the adjacent joint.

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• Jaspal Singh, MD, Principal investigator, Department of Rehabilitation Medicine | Weill Cornell Medicine