Using mesenchymal stem cells during allogeneic stem cell transplantation
Co-transplantation of Mesenchymal Stromal Cells in Allogeneic Hematopoietic Stem Cell Transplantation
PHASE2; PHASE3 · Fujian Medical University · NCT04247945
This study is testing whether adding mesenchymal stem cells to a stem cell transplant can help patients recover better and reduce complications like graft versus host disease.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | N/A to 65 Years |
| Sex | All |
| Sponsor | Fujian Medical University (other) |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT04247945 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of co-transplanting mesenchymal stem cells (MSCs) alongside allogeneic hematopoietic stem cell transplantation (allo-HSCT). The research aims to evaluate how MSC infusion may enhance engraftment, reduce the incidence of graft versus host disease (GVHD), and improve overall survival rates post-transplant. By focusing on the immunomodulatory and anti-inflammatory properties of MSCs, the study seeks to determine their potential benefits in the transplant process.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals under 65 years old who are eligible for allogeneic stem cell transplantation and have adequate organ function.
Not a fit: Patients who are pregnant, lactating, or have significant co-morbidities that prevent MSC administration may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved transplant outcomes and reduced complications for patients undergoing allo-HSCT.
How similar studies have performed: Other studies have shown promising results with MSCs in transplant settings, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed written informed consent * Aged \<65 years * Willing to transplant * Cardiac: Left ventricular ejection fraction ≥ 50% * Adequate renal and hepatic function * Performance status: Karnofsky ≥ 70% Exclusion Criteria: * Pregnant or lactating females. * Any co-morbidity precluding the administration of MSCs.
Where this trial is running
Fuzhou, Fujian
- Union Hospital,Fujian Medical University — Fuzhou, Fujian, China (RECRUITING)
Study contacts
- Study coordinator: Ting Yang, Prof.
- Email: yang.hopeting@gmail.com
- Phone: +86-591-86218041
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: Allogeneic Hematopoietic Stem Cell Transplantation