Ex Vivo T-Cell Depletion of Mobilized Peripheral Blood Stem Cells Via CD34-Selection
Participants are being asked to take part in this study because treatment of his or her disease requires a stem cell transplant. Stem cells or "mother" cells are the source of normal blood cells and lead to recovery of blood counts after bone marrow transplantation. Unfortunately, there is not a perfectly matched stem
| Condition(s) | Stem Cell Transplant, Allogeneic |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | Participants are being asked to take part in this study because treatment of his or her disease requires a stem cell transplant. Stem cells or "mother" cells are the source of normal blood cells and lead to recovery of blood counts after bone marrow transplantation. Unfortunately, there is not a perfectly matched stem cell donor (like a sister or brother) for the participant and his or her disease does not permit enough time to identify another donor (like someone from a registry list that is not his or her relative) or another suitable donor has not been identified. However, a close relative of the patient has been identified whose stem cells are not a perfect match, but can be used. Alternatively, the patient may have already received a stem cell transplant but have evidence of mixed chi |
| Who can participate | Inclusion criteria for Stem Cell Transplant WITH Conditioning (COHORT 1) 1. Patient requiring allogeneic SCT 2. Age between birth and 70 years 3. Patient and/or responsible person able to understand and sign consent Exclusion criteria for Stem Cell Transplant WITH Conditioning (COHORT 1) 1. Active, acute GvHD \> grade II or extensive, chronic GvHD 2. Severe life, threatening infection 3. Pulmonary dysfunction (FEV1, FVC or DLCO 40% of predicted or 3 SD below normal) 4. Cardiac dysfunction (LVSF less than 25%) 5. Psychiatric disturbance 6. Lansky or Karnofsky score \< 50% 7. The presence of severe hepatic disease (direct bilirubin \>3x upper limit of normal and AST \> 5x upper limit of normal). 8. Creatinine \> 3x normal 9. Known HIV Positivity 10. Pregnancy Inclusion Criteria for CD34+ Top |
| Ages | 70 Years |
| Sex | All |
| Lead sponsor | Baylor College of Medicine |
| Locations | Houston, Texas, United States; Houston, Texas, United States |
| Start date | 2010-10 |
| NCT ID | NCT01189786 |
| Official listing | https://clinicaltrials.gov/study/NCT01189786 |