Cryopreserved Hair Follicles for Disease and Cell Replacement

NCT06764719 — Recruiting, 100 participants, Acorn Biolabs Inc.

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Characterization of Cryopreserved Plucked Hair Follicles and Generation of Functional Cell Lines for Disease Modeling and Cell Replacement Therapies

RegistryNCT06764719
StatusRecruiting
Study typeObservational
Enrollment100 (Estimated)
SponsorAcorn Biolabs Inc. (Industry)
ConditionsDiabetes Mellitus, Sport Injury, Injury Traumatic
Datesstart 2025-01-06, primary completion 2026-01-01 (estimated), completion 2026-03-01 (estimated), first posted 2025-01-08, last updated 2025-10-02
Locations1 site in Canada

Related Papers Related Patents Related Grants Related Experts
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-Summary

To explore the application of cells expanded from plucked hair follicles after collection, transport, and cryopreservation, in disease modeling and cell-based therapies.

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+Detailed description

Hair Follicles collected and transported in Acorn's proprietary transport media can serve has therapeutic starting materials for future cell-based therapeutics. This study is to characterize primary cell outgrowth, functional stem cell generation and induced pluripotent stem cell line(s) from primary outgrowth(s) as well as evaluate and characterize differentiation of stem cell lines into functional cell types required for various disease states and cell-based application(s).

+Arms and interventions

ArmTypeInterventionsDescription
Hair Follicle DonorsHealthy individuals, aged 18-80, who will have hair follicles collected

+Outcome measures

Primary outcomes

  • Characterize primary cellular outgrowth(s) [30 days]: 10 hair follicles will be placed in a tissue culture plate per participants. Over the course of 30 days, the outgrowth percentage (the number of outgrowths present out of 10 will be monitored and the confluency (percent of cells present in relation to surface area) will be noted for each participant.
  • Evaluate functional stem cell generation and induced pluripotent stem cell line(s) from primary outgrowth(s) [21 days]: 1 million keratinocytes will be taken for reprogramming for each participant. The number of iPS colonies observed on day 21 will be noted, resulting in a reprogramming efficiency score.
  • Evaluate and characterize differentiation of stem cell lines into functional cell types required for various disease states and cell-based application(s) [30 days]: iPS cell lines which have been confirmed to be pluripotent will be differentiated into pancreatic progenitor cells and hematopoietic stem cells. The cells will be analyzed using FLOW cytometry and the percentage of double positive cells will be noted for each participant. This will be repeated for multiple pathways such as the hematopoietic and endothelial lineage(s).

+Eligibility

Sex: All, ages: 18 Years to 80 Years, accepts healthy volunteers

Inclusion Criteria:

* Gender: Male or Female.
* Age: ≥18 and ≤80 years.
* Language proficiency: Able to read and understand English.
* Informed consent: Willing to provide written, informed consent to participate in all study activities.

Exclusion Criteria:

* Scalp/Hair Disorders: Subjects diagnosed with active scalp infections or inflammatory skin conditions.
* Systemic Conditions: Subjects with chronic illnesses, such as autoimmune diseases or diabetes, that may impact scalp health or wound healing.
* Medications: Subjects on immunosuppressants, steroids, or other medications associated with hair loss.

+Locations (1)

FacilityCityCountryStatus
Acorn BiolabsToronto, QuebecCanadaRecruiting