Half-Matched stem cell transplants get safer with new Cell-Sorting technique

NCT ID NCT01189786

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
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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

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

About 241 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2010

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

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

Up to 70 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Houston Methodist Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • Texas Children's Hospital

    RECRUITING

    Houston, Texas, 77030, United States

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