Infusion of stem cells from umbilical cords for treating chronic kidney disease
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Chronic Kidney Disease.
PHASE1 · The Foundation for Orthopaedics and Regenerative Medicine · NCT05018845
This study is testing whether a single infusion of stem cells from umbilical cords can help improve kidney function in people with chronic kidney disease.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Sex | All |
| Sponsor | The Foundation for Orthopaedics and Regenerative Medicine (other) |
| Locations | 1 site (St John's) |
| Trial ID | NCT05018845 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 (UC-MSCs) in patients with Chronic Kidney Disease (CKD). Participants will receive a single infusion of 100 million UC-MSCs and will be monitored for safety and efficacy at various intervals over a period of up to four years. The study aims to determine whether this innovative treatment can improve kidney function and overall patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with chronic kidney disease who are willing to participate and provide informed consent.
Not a fit: Patients with active infections, cancers, or other significant health issues may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients suffering from chronic kidney disease.
How similar studies have performed: Previous studies have indicated that stem cell treatments can be safe and effective for chronic kidney disease, suggesting a promising avenue for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Chronic Kidney Disease * 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
- Medical Surgical Associates Center — St John's, Antigua and Barbuda (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.
Conditions: Chronic Kidney Diseases, Renal Failure, stem cell treatment, Kidney Disease