Aplastic Anemia Clinical Trial
Official title:
Phase II Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat SAA
The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (MSCs) derived from human umbilical cord/placenta at a dose of 1.0E+6 MSC/kg in subject for the therapy of severe aplastic anemia (SAA).
Severe aplastic anemia (SAA) is a condition that involves a low level of red blood cells,
white blood cells, and platelets without evidence of another bone marrow disease. Patients
with severe aplastic anemia produce too few blood cells, causing fatigue, easy bruising and
bleeding, and susceptibility to infections. In many cases, the very low blood counts result
from an autoimmune process. The patient's own immune system damages their stem cells in bone
marrow.
Although immune-suppressing drugs, such as corticosteroids, CsA and ATG, have been used in
the treatment of SAA, however, many studies have indicated that the overall response rate to
these drugs is less than 60%. Addition, the severe side effects of these immune-suppressing
drugs have also been observed. The management of SAA patients therefore remains
unsatisfactory and targeted therapies are needed. Human MSCs isolated from human umbilical
cord/placenta have been shown to have immunosuppressive, stimulating hematopoiesis and
tissue repairing properties. This study will evaluate the safety and effectiveness of MSC
transplantation in the SAA patients.
This study will last 2 to 3 years. Participants will be randomly assigned to receive either
MSC transplant and CsA therapy (experimental group) or CsA therapy alone (control group).
Patients will undergo MSC transplant at the start of the study on Day 0. After 3 months,
patients will receive the second MSC transplantation. After six and twelve months from the
first transplantation, patients will be evaluated.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03025698 -
A Phase II Dose-escalation Study Characterizing the PK of Eltrombopag in Pediatric Patients With Previously Untreated or Relapsed Severe Aplastic Anemia or Recurrent Aplastic Anemia
|
Phase 2 | |
| Completed |
NCT00987480 -
Hematopoietic Stem Cell Transplantation for the Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor, Using a Chemotherapy Only Cytoreduction With Busulfan, Cyclophosphamide and Fludarabine
|
Phase 2 | |
| Completed |
NCT00767650 -
Neuropsychological Effects of Immunosuppressive Treatment in Subjects With Aplastic Anemia
|
N/A | |
| Completed |
NCT02833805 -
NMA Haplo or MUD BMT for Newly Diagnosed Severe Aplastic Anemia
|
Phase 2 | |
| Not yet recruiting |
NCT02833493 -
Study of MRI Monitoring in Patients With Aplastic Anemia and Low or Int-1 Risk of MDS Complicated With Iron Overload
|
N/A | |
| Recruiting |
NCT02028416 -
Comparison of Two Different Doses of Rabbit ATG-Fresenius With Cyclosporin in the Treatment of Acquired Aplastic Anaemia
|
N/A | |
| Completed |
NCT00004474 -
Phase III Randomized Study of Cyclophosphamide With or Without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients With Aplastic Anemia
|
Phase 3 | |
| Recruiting |
NCT05031897 -
Reduced-Intensity Conditioning for the Prevention of Treatment-Related Mortality in Patients Who Undergo a Hematopoietic Stem Cell Transplant
|
Phase 2 | |
| Completed |
NCT04439006 -
Ibrutinib for the Treatment of COVID-19 in Patients Requiring Hospitalization
|
Phase 1 | |
| Not yet recruiting |
NCT05996393 -
CsA+ATG+AVA vs. CsA+AVA for the Treatment of Newly-diagnosed SAA in the Elderly
|
Phase 4 | |
| Completed |
NCT02462252 -
Phase IIA Open Label Study to Evaluate Efficacy and Safety of BL-8040 Followed by (hATG), Cyclosporine and Methyprednisolone in Adult Subjects With Aplastic Anemia or Hypoplastic Myelodysplastic Syndrome
|
Phase 2 | |
| Completed |
NCT00513175 -
Non-Myeloablative Allogeneic Stem Cell Transplantation With Matched Unrelated Donors for Treatment of Hematologic Malignancies, Renal Cell Carcinoma, and Aplastic Anemia
|
N/A | |
| Completed |
NCT01272817 -
Nonmyeloablative Allogeneic Transplant
|
N/A | |
| Completed |
NCT00001398 -
Stem Cell Factor Medication for Aplastic Anemia
|
Phase 1 | |
| Recruiting |
NCT01861093 -
Safety Study of Cord Blood Units for Stem Cell Transplants
|
Phase 2 | |
| Not yet recruiting |
NCT05018936 -
Efficacy and Safety of Hetrombopag in Non-severe Aplastic Anemia
|
Phase 2/Phase 3 | |
| Completed |
NCT00065260 -
Rabbit Antithymocyte Globulin Versus Campath-1H for Treating Severe Aplastic Anemia
|
Phase 2 | |
| Recruiting |
NCT02007811 -
Open-label Clinical Trial to Investigate the Safety and Tolerability of Allogeneic B-cell Concentrates for Immune Reconstitution After Allogeneic Stem Cell Transplantation Measured as Response to a Antedated Single Vaccination
|
Phase 1/Phase 2 | |
| Recruiting |
NCT01758042 -
Bone Marrow and Kidney Transplant for Patients With Chronic Kidney Disease and Blood Disorders
|
N/A | |
| Terminated |
NCT01500161 -
Pooled Unrelated Donor Umbilical Cord Blood Transplant For Hematologic Malignancy Needing Allogeneic Stem Cell Transplant Without Related HLA-Match
|
Phase 2 |