RecruitingRecruiting
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for RA
NCT05003934 · The Foundation for Orthopaedics and Regenerative Medicine
In plain English
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Official title
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Rheumatoid Arthritis
About this study
Studies have shown that stem cell treatment is safe and efficacious for the treatment of Rheumatoid Arthritis (RA). Patients with RA 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
Eligibility criteria
Inclusion Criteria:
* Diagnosis of Rheumatoid Arthritis
* 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
Study design
Enrollment target: 20 participants
Allocation: na
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2021-11-07
Estimated completion: 2026-09
Last updated: 2025-04-08
Interventions
Biological: AlloRx
Primary outcomes
- • Safety (adverse events) (Four year follow-up)
Sponsor
The Foundation for Orthopaedics and Regenerative Medicine · other
Contacts & investigators
InvestigatorChadwick Prodromos, MD · principal_investigator, The Foundation for Orthopaedics and Regenerative Medicine
All locations (2)
Medical Surgical Associates CenterRecruiting
St John's, Antigua and Barbuda
Center for Investigation in Tissue Engineering and Cellular TherapyRecruiting
Buenos Aires, Argentina