Clinical trial · Interventional
Safety and Efficacy Study of Umbilical Cord Blood-Drived Mesenchymal Stem Cells to Promote Engraftment of Unrelated Hematopoietic Stem Cell Transplantation
Phase 1/2 Study of Umbilical Cord Blood-Drived Mesenchymal Stem Cells Infusion for Promotion of Engraftment and Prevention of an Graft Rejection and Graft-versus-Host Disease After Unrelated Hematopoietic Stem Cell Transplantation.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and efficacy of PROMOSTEM (human umbilical cord blood-derived mesenchymal stem cells) at a dose of 1 and 5x1,000,000 hMSC/kg in subject for the promotion of an engraftment and prevention of graft rejection and Graft-Versus-Host Disease after unrelated hematopoietic stem cell transplantation for children with acute leukemia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Leukemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Human umbilical cord blood-derived mesenchymal stem cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- at a dose of 1x1,000,000 hMSC/kg
- interventionNames
- Biological: Human umbilical cord blood-derived mesenchymal stem cells
- type
- EXPERIMENTAL
- label
- 2
- description
- at a dose of 5x1,000,000 hMSC/kg
- interventionNames
- Biological: Human umbilical cord blood-derived mesenchymal stem cells
Primary outcomes (1)
- measure
- - Day of neutrophil engraftment - Day of platelet engraftment - Evaluation of chimerism - Evaluation of engraftment rate
- timeFrame
- 28 and 100 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient age 2\~19 years old with plan to have unrelated hematopoietic stem cell transplantation with acute leukemia 2. Patient never has an experience of hematopoietic stem cell transplantation 3. Patient must have an acute leukemia with a complete remission. 4. Patients must have an ECOG 0\~2. 5. No moderate or sever organ dysfunction : Ejection fraction \> 45%; Creatinine \<2.0 mg/ml; Serum bilirubin \< 2 mg/ml; AST/ALT \< 200 IU/L. 6. Patient must not have an transplantation with different source of hematopoietic stem cell such as bone marrow and cord blood. 7. Patient must not have an infection needed an administration of non-oral antibiotics. 8. No active severe infection derived form virus or fungus. 9. Each patient / patient's guardian must sign written informed consent. Exclusion Criteria: 1. Patient has previously received hematopoietic stem cell transplantation. 2. Patient plans to have a related hematopoietic stem cell transplantation. 3. Patient has a severe internal disease. 4. Patient has enrolled another clinical trial study within last 4 weeks.
References
Publications (0)
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