Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Diabetes

NCT05003908 | Terminated Phase 1 FDA Drug

• 1 other identifier: SC-10-ATG-11-01
• Study Type: interventional
• Target: 2
• Locations: 2 countries
• Sites: 2

Brief 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 Diabetes

Conditions

Diabetes

Keywords

Diabetes; stem cell treatment

Outcome Measures

Primary Outcomes (1)

• Safety (adverse events)

  Clinical monitoring of possible adverse events or complications

  Four year follow-up

Secondary Outcomes (3)

• Efficacy: the level of A1C

  Four year follow-up

• Efficacy: the level of C-Peptide

  Four year follow-up

• Efficacy: Insulin dose reduction

  Four year follow-up

Study Arms (1)

Treatment Group

EXPERIMENTAL

Single intravenous infusion of 100 million cells

Biological: AlloRx

Interventions

AlloRx BIOLOGICAL

cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Treatment Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Diabetes
• Understanding and willingness to sign a written informed consent document

You may not qualify if:

• 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

Sponsors & Collaborators

• The Foundation for Orthopaedics and Regenerative Medicine: lead

Study Sites (2)

Medical Surgical Associates Center

St John's, Antigua and Barbuda

Location

Center for Investigation in Tissue Engineering and Cellular Therapy

Buenos Aires, Argentina

Location

Related Publications (3)

• Hu J, Yu X, Wang Z, Wang F, Wang L, Gao H, Chen Y, Zhao W, Jia Z, Yan S, Wang Y. Long term effects of the implantation of Wharton's jelly-derived mesenchymal stem cells from the umbilical cord for newly-onset type 1 diabetes mellitus. Endocr J. 2013;60(3):347-57. doi: 10.1507/endocrj.ej12-0343. Epub 2012 Nov 16.

  PMID: 23154532 BACKGROUND

• Jiang R, Han Z, Zhuo G, Qu X, Li X, Wang X, Shao Y, Yang S, Han ZC. Transplantation of placenta-derived mesenchymal stem cells in type 2 diabetes: a pilot study. Front Med. 2011 Mar;5(1):94-100. doi: 10.1007/s11684-011-0116-z. Epub 2011 Mar 17.

  PMID: 21681681 BACKGROUND

• Cai J, Wu Z, Xu X, Liao L, Chen J, Huang L, Wu W, Luo F, Wu C, Pugliese A, Pileggi A, Ricordi C, Tan J. Umbilical Cord Mesenchymal Stromal Cell With Autologous Bone Marrow Cell Transplantation in Established Type 1 Diabetes: A Pilot Randomized Controlled Open-Label Clinical Study to Assess Safety and Impact on Insulin Secretion. Diabetes Care. 2016 Jan;39(1):149-57. doi: 10.2337/dc15-0171. Epub 2015 Dec 1.

  PMID: 26628416 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Chadwick Prodromos, MD

  The Foundation for Orthopaedics and Regenerative Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 13, 2021
• Study Start: November 6, 2021
• Primary Completion: April 4, 2025
• Study Completion: April 4, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

AN (1); AR (1)