Infusion of stem cells from umbilical cords for treating Systemic Sclerosis
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Systemic Sclerosis
This study is testing whether a single infusion of stem cells from umbilical cords can help people with Systemic Sclerosis feel better and improve their condition.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Sex | All |
| Sponsor | The Foundation for Orthopaedics and Regenerative Medicine Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 2 sites (St John's and 1 other locations) |
| Trial ID | NCT05016804 on ClinicalTrials.gov |
What this trial studies
This trial investigates the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells in patients with Systemic Sclerosis. Participants will receive a single infusion of 100 million stem cells and will be monitored for safety and efficacy at various intervals over a period of up to four years. The study aims to evaluate the potential benefits of this innovative treatment approach for a condition that currently has limited effective therapies.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with Systemic Sclerosis who are willing to provide informed consent.
Not a fit: Patients with active infections, cancers, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from Systemic Sclerosis.
How similar studies have performed: Previous studies have indicated that stem cell treatments can be safe and effective for Systemic Sclerosis, suggesting a promising avenue for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Systemic Sclerosis * 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
Where this trial is running
St John's and 1 other locations
- Medical Surgical Associates Center — St John's, Antigua and Barbuda (Recruiting)
- Center for Investigation in Tissue Engineering and Cellular Therapy — Buenos Aires, Argentina (Recruiting)
Study contacts
- Principal investigator: Chadwick Prodromos, MD — The Foundation for Orthopaedics and Regenerative Medicine
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.