Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Intravenous Infusion for CKD

NCT05018845 — Phase 1, Terminated, 20 participants, The Foundation for Orthopaedics and Regenerative Medicine

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Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Chronic Kidney Disease.

Registry	NCT05018845
Status	Terminated - Inadequate treatment response observed in preliminary data did not justify enrolling further study participants
Phase	Phase 1
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	20 (Actual)
Sponsor	The Foundation for Orthopaedics and Regenerative Medicine (Other)
Conditions	Chronic Kidney Diseases
Interventions	AlloRx (Biological)
Dates	start 2021-11-06, primary completion 2025-11-30, completion 2025-11-30, first posted 2021-08-24, last updated 2026-10-20
Locations	1 site in Antigua and Barbuda

-Summary

This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Chronic Kidney Disease.

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+Detailed description

Studies have shown that stem cell treatment is safe and efficacious for the treatment of Chronic Kidney Disease (CKD). This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of CKD. Patients with CKD will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

For patients with more severe disease an autologous Effector cells (activated lymphocytes) treatment will be utilized created from the patient's own cells obtained by apheresis.

+Arms and interventions

Arm	Type	Interventions	Description
Treatment Group (AlloRx)	Experimental	Biological: AlloRx	Single intravenous infusion of 100 million cells

AlloRx (Biological): cultured allogeneic adult umbilical cord derived mesenchymal stem cells

+Outcome measures

Primary outcomes

Safety (adverse events) [Four year follow-up]: Clinical monitoring of possible adverse events or complications

Secondary outcomes

Efficacy: creatinine levels [Four year follow-up]: It will be completed for each follow up point.
Efficacy: changes in eGFR [Four year follow-up]: It will be completed for each follow up point.

+Eligibility

Sex: All

Inclusion Criteria:

* Diagnosis of Chronic Kidney Disease
* Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

* Active infection
* Active cancer
* Chronic multisystem organ failure
* Pregnancy
* Clinically significant abnormalities on pre-treatment laboratory evaluation
* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
* Continued drug abuse
* Pre-menopausal women not using contraception
* Previous organ transplant
* Hypersensitivity to sulfur

+Locations (1)

Facility	City	Country	Status
Medical Surgical Associates Center	St John's	Antigua and Barbuda

+Publications

Belingheri M, Lazzari L, Parazzi V, Groppali E, Biagi E, Gaipa G, Giordano R, Rastaldi MP, Croci D, Biondi A, Rebulla P, Edefonti A, Ghio L. Allogeneic mesenchymal stem cell infusion for the stabilization of focal segmental glomerulosclerosis. Biologicals. 2013 Nov;41(6):439-45. doi: 10.1016/j.biologicals.2013.09.004. Epub 2013 Oct 14. PMID 24135082
Rahyussalim AJ, Saleh I, Kurniawati T, Lutfi APWY. Improvement of renal function after human umbilical cord mesenchymal stem cell treatment on chronic renal failure and thoracic spinal cord entrapment: a case report. J Med Case Rep. 2017 Nov 30;11(1):334. doi: 10.1186/s13256-017-1489-7. PMID 29187247

+Investigators

Chadwick Prodromos, MD, Principal investigator, The Foundation for Orthopaedics and Regenerative Medicine