Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Diabetes
NCT ID: NCT05003908
Last Updated: 2025-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
2 participants
INTERVENTIONAL
2021-11-06
2025-04-04
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Group
Single intravenous infusion of 100 million cells
AlloRx
cultured allogeneic adult umbilical cord derived mesenchymal stem cells
Interventions
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AlloRx
cultured allogeneic adult umbilical cord derived mesenchymal stem cells
Eligibility Criteria
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Inclusion Criteria
* Understanding and willingness to sign a written informed consent document
Exclusion Criteria
* 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
ALL
No
Sponsors
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The Foundation for Orthopaedics and Regenerative Medicine
OTHER
Responsible Party
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Principal Investigators
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Chadwick Prodromos, MD
Role: PRINCIPAL_INVESTIGATOR
The Foundation for Orthopaedics and Regenerative Medicine
Locations
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Medical Surgical Associates Center
St John's, , Antigua and Barbuda
Center for Investigation in Tissue Engineering and Cellular Therapy
Buenos Aires, , Argentina
Countries
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References
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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.
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.
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.
Other Identifiers
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SC-10-ATG-11-01
Identifier Type: -
Identifier Source: org_study_id
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