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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05003908
• Other study ID #: SC-10-ATG-11-01
• Status: Recruiting
• Phase: Phase 1
• Start date: February 1, 2022
• Est. completion date: November 2025

Study information

• Verified date: October 2022
• Source: The Foundation for Orthopaedics and Regenerative Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Studies have shown that stem cell treatment is safe and efficacious for the treatment of Diabetes. Patients with Diabetes will receive a single intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. 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 requiring chemotherapeutic drugs such as methotrexate, an autologous T Cell vaccine will be utilized created from the patient's own T cells obtained by apheresis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosis of Diabetes

• 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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Antigua and Barbuda	Medical Surgical Associates Center	St. John's
Argentina	Center for Investigation in Tissue Engineering and Cellular Therapy	Buenos Aires
Mexico	Medyca Bosques	San Pedro Garza García	N.L

Sponsors (1)

Lead Sponsor	Collaborator
The Foundation for Orthopaedics and Regenerative Medicine

Countries where clinical trial is conducted

Antigua and Barbuda,  Argentina,  Mexico, 

References & Publications (3)

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. — View Citation

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. Epub 2012 Nov 16. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (adverse events)	Clinical monitoring of possible adverse events or complications	Four year follow-up
Secondary	Efficacy: the level of A1C	A1C blood test will be completed for each follow up point.	Four year follow-up
Secondary	Efficacy: the level of C-Peptide	C-Peptide test will be completed for each follow up point.	Four year follow-up
Secondary	Efficacy: Insulin dose reduction	Changes of insulin dosage for each follow up point.	Four year follow-up