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New treatment option for Stem Cell Transplant
Official title Ex Vivo T-Cell Depletion of Mobilized Peripheral Blood Stem Cells Via CD34-Selection
ClinicalTrials.gov ID: NCT01189786
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 70
You may be able to join if
- for Stem Cell Transplant WITH Conditioning (COHORT 1)
- Patient requiring allogeneic SCT
- Age between birth and 70 years
- Patient and/or responsible person able to understand and sign consent
You likely can't join if
- for Stem Cell Transplant WITH Conditioning (COHORT 1)
- Active, acute GvHD \> grade II or extensive, chronic GvHD
- Severe life, threatening infection
- Pulmonary dysfunction (FEV1, FVC or DLCO 40% of predicted or 3 SD below normal)
- Cardiac dysfunction (LVSF less than 25%)
- Psychiatric disturbance
See the full eligibility criteria
- for Stem Cell Transplant WITH Conditioning (COHORT 1)
- Patient requiring allogeneic SCT
- Age between birth and 70 years
- Patient and/or responsible person able to understand and sign consent
- for Stem Cell Transplant WITH Conditioning (COHORT 1)
- Active, acute GvHD \> grade II or extensive, chronic GvHD
- Severe life, threatening infection
- Pulmonary dysfunction (FEV1, FVC or DLCO 40% of predicted or 3 SD below normal)
- Cardiac dysfunction (LVSF less than 25%)
- Psychiatric disturbance
- Lansky or Karnofsky score \< 50%
- The presence of severe hepatic disease (direct bilirubin \>3x upper limit of normal and AST \> 5x upper limit of normal).
- Creatinine \> 3x normal
- Known HIV Positivity
- Pregnancy Inclusion Criteria for CD34+ Topoff WITHOUT conditioning (COHORT 2)
- Allogeneic SCT Recipient requiring additional cellular therapy
- Age between birth and 70 years
- Patient and/or responsible person able to understand and sign consent
- At least ONE of the following must be answered YES for a patient to be eligible to receive CD34+ topoff:
- Evidence of mixed chimerisms (less than 95% donor cells)
- Evidence of poor bone marrow function (bone marrow cellularity less than 50% with at least one cytopenia)
- Relapsed or persistent disease Exclusion criteria for CD34+ Topoff WITHOUT conditioning (COHORT 2)
- Active, acute GvHD \> grade II or extensive, chronic GvHD
- Severe life, threatening infection
- Known HIV positivity
- Pregnancy Inclusion Criteria for CD34+ Topoff WITH conditioning (COHORT 3)
- Allogeneic SCT Recipient requiring additional cellular therapy
- Age between birth and 70 years
- Patient and/or responsible person able to understand and sign consent
- At least ONE of the following must be answered YES for a patient to be eligible to receive CD34+ topoff:
- Evidence of mixed chimerisms (less than 95% donor cells)
- Evidence of poor bone marrow function (bone marrow cellularity less than 50% with at least one cytopenia)
- Relapsed or persistent disease Exclusion criteria for CD34+ Topoff WITH Conditioning (COHORT 3)
- Active, acute GVHD \> grade II or extensive, chronic GvHD
- Severe life, threatening infection
- Pulmonary disfunction (FEV1, FVC or DLCO 40% of predicted or 3 SD below normal)
- Cardiac dysfunction (LVSF less than 25%)
- Psychiatric disturbance
- Lansky or Karnofsky score \< 50%
- The presence of severe hepatic disease (direct bilirubin \> 3x upper limit of normal and AST \> 5x upper limit of normal)
- Creatinine \> 3x normal
- Known HIV positivity
- Pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.