Half-Matched stem cell transplants get safer with new Cell-Sorting technique
NCT ID NCT01189786
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is for people who need a stem cell transplant but only have a half-matched donor, like a parent or child. Researchers are using a machine to pick out only the CD34+ stem cells from the donor's blood, removing the T cells that can cause a serious complication called graft-versus-host disease (GvHD). The goal is to help the new stem cells grow and lower the risk of GvHD. The study will include up to 241 participants of all ages.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 241 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2010
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Up to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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+ Topoff WITHOUT conditioning (COHORT 2) 1. Allogeneic SCT Recipient requiring additional cellular therapy 2. Age between birth and 70 years 3. Patient and/or responsible person able to understand and sign consent 4. At least ONE of the following must be answered YES for a patient to be eligible to receive CD34+ topoff: 1. Evidence of mixed chimerisms (less than 95% donor cells) 2. Evidence of poor bone marrow function (bone marrow cellularity less than 50% with at least one cytopenia) 3. Relapsed or persistent disease Exclusion criteria for CD34+ Topoff WITHOUT conditioning (COHORT 2) 1. Active, acute GvHD \> grade II or extensive, chronic GvHD 2. Severe life, threatening infection 3. Known HIV positivity 4. Pregnancy Inclusion Criteria for CD34+ Topoff WITH conditioning (COHORT 3) 1. Allogeneic SCT Recipient requiring additional cellular therapy 2. Age between birth and 70 years 3. Patient and/or responsible person able to understand and sign consent 4. At least ONE of the following must be answered YES for a patient to be eligible to receive CD34+ topoff: 1. Evidence of mixed chimerisms (less than 95% donor cells) 2. Evidence of poor bone marrow function (bone marrow cellularity less than 50% with at least one cytopenia) 3. Relapsed or persistent disease Exclusion criteria for CD34+ Topoff WITH Conditioning (COHORT 3) 1. Active, acute GVHD \> grade II or extensive, chronic GvHD 2. Severe life, threatening infection 3. Pulmonary disfunction (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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Houston Methodist Hospital
RECRUITINGHouston, Texas, 77030, United States
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Texas Children's Hospital
RECRUITINGHouston, Texas, 77030, United States
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