Using stem cells from umbilical cords to treat lung diseases
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Pulmonary Diseases
This study is testing if a single infusion of stem cells from umbilical cords can help people with lung diseases like asthma and COPD feel better and improve their health over time.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Sex | All |
| Sponsor | The Foundation for Orthopaedics and Regenerative Medicine Academic / other |
| Locations | 1 site (St John's) |
| Trial ID | NCT05147688 on ClinicalTrials.gov |
What this trial studies
This trial investigates the safety and efficacy of intravenous infusions of cultured allogeneic adult umbilical cord-derived mesenchymal stem cells (UC-MSCs) for patients with pulmonary diseases such as asthma and chronic obstructive pulmonary disease (COPD). Participants will receive a single infusion of 100 million UC-MSCs and will be monitored for safety and effectiveness over a period of up to 48 months. Evaluations will occur at multiple time points to assess the treatment's impact on their condition.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with pulmonary diseases who are willing to provide informed consent.
Not a fit: Patients with active infections, cancers, or other serious health conditions 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 pulmonary diseases.
How similar studies have performed: While the use of stem cells for pulmonary diseases is an emerging field, this specific approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of pulmonary 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.