Simpler stem cell collection could ease donor burden in Life-Threatening anemia
NCT ID NCT07629947
First seen Jun 25, 2026 · Last updated Sep 17, 2026 · Updated 4 times
Summary
This trial tests whether using only blood stem cells (instead of blood stem cells plus bone marrow) for a half-matched transplant is safe and effective for severe aplastic anemia. 180 patients aged 18-40 will be randomly assigned to one of two graft sources. The main goal is to see if the simpler method leads to similar rates of graft-versus-host disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- stem cell transplant (using donor blood stem cells, with or without bone marrow)
- What this could lead to
- If successful, this could make stem cell transplants for severe aplastic anemia simpler and less invasive for donors, while keeping the same level of safety and effectiveness for patients.
- What could go wrong
- This is an early-stage trial (not yet recruiting) with 180 participants, so results may not apply to everyone. Using only blood stem cells might increase the risk of graft-versus-host disease, a serious complication.
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 180 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Dec 2029
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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18 to 40 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: * Patients with newly diagnosed or relapsed severe aplastic anemia (SAA) or very severe aplastic anemia (vSAA) according to the Camitta criteria. * SAA is defined as bone marrow cellularity \<25% and at least two of the following peripheral blood criteria: absolute neutrophil count \<0.5 × 10\^9/L, platelet count \<20 × 10\^9/L, or reticulocyte count \<20 × 10\^9/L. * vSAA is defined as SAA with an absolute neutrophil count \<0.2 × 10\^9/L. * Age 18 to 40 years. * Availability of a haploidentical related donor. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. * Adequate organ function, defined as follows: * Cardiac function: left ventricular ejection fraction ≥50% and no severe arrhythmia. * Hepatic function: total bilirubin ≤2 times the upper limit of normal and alanine aminotransferase/aspartate aminotransferase ≤3 times the upper limit of normal. * Renal function: creatinine clearance ≥60 mL/min. * No active infection. * For women of childbearing potential, a negative pregnancy test is required. * All patients must agree to use effective contraception during the study period. * Written informed consent provided by the patient or legal representative. Exclusion Criteria: * Presence of hematologic malignancy or myelodysplastic syndrome-related chromosomal abnormalities, such as +8 or del(7q). * Prior allogeneic hematopoietic stem cell transplantation or prior organ transplantation. * Availability of an HLA-matched sibling donor. * Active uncontrolled infection, including unresolved invasive fungal disease, active tuberculosis, sepsis, or other uncontrolled infections. * Severe comorbidities, defined as a Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score ≥4, or uncontrolled autoimmune disease. * Donor-related contraindications, including donor age \<12 years or \>65 years, donor body mass index \<18 or \>35 kg/m², contraindications to anesthesia, or contraindications to bone marrow harvest. * Psychiatric illness that prevents cooperation with study procedures, or any condition considered by the investigator to make the patient unsuitable for study participation.
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Conditions
The condition(s) this trial relates to.
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
1 site. 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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Peking university people's hospital
RECRUITINGBeijing, Beijing Municipality, 100033, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Three-Drug combo shield stem cell transplant patients from a dangerous immune attack?
- Experimental drug targets bone marrow failure
- New drug cocktail aims to free aplastic anemia patients from transfusions
- Aplastic anemia drug combo study pulled before starting
- New drug combo shows promise for rare blood disorder
- New stem cell infusion could boost transplant success in rare blood disorder