New study aims to uncover hidden danger in stem cell transplants
NCT ID NCT07381205
First seen Jun 25, 2026 · Last updated Sep 17, 2026 · Updated 5 times
Summary
This study will follow 85 adults receiving stem cell transplants to track a serious but often missed complication called TA-TMA. Researchers want to find out how common it is and how it affects survival. Participants will provide blood samples and have standard follow-up care.
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.
- Participants
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About 85 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2027
An estimate. Start dates often move.
- Expected to finish
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Nov 2028
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.
Who is studied
Adult patients undergoing allogeneic stem cell transplant (SCT) deemed to be at high risk for developing Transplant Associated Thrombotic Microangiopathy (TA-TMA) as per inclusion criteria.
- Ages
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18 years and older
- 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: * Inclusion Criteria 1. Adult male or female, age ≥18 2. Undergoing allogeneic SCT at UAB for any indication and any donor source. 3. For patients in cohort 1: Patients deemed high-risk for developing high-risk TA-TMA as stated by any of the following criteria\*: 1. BMI \> 35\[42\] 2. Mismatched donor (either Haploidentical or Mismatched Unrelated donor)\[18, 29\] 3. Non-Malignant Transplant Indication (Severe Aplastic Anemia or Sickle Cell Disease)\[18, 43\] 4. Acute Lymphoblastic Leukemia (any kind)\[18, 31\] 5. African American, Hispanic, Asian or Native American Ethnicity \[44\] 6. Myeloablative Conditioning Regimen\[18\] 7. Pre-Existing Renal Disease\*\* (defined as any of the following: 24 Hr Creatinine Clearance \<60, baseline serum creatinine \> 1.2, 24 hr proteinuria \>150mg or random spot urine Protein Creatinine ratio \> 150mg/g)\[20, 45\] 8. TBI-containing conditioning regimen \>400cGy \[46\] 9. Prior Autologous or Allogeneic SCT\[45\] * \*Some of these criteria have been adapted from pediatric literature due to a higher number of publications in that setting and in cases where the adult data is lacking or contradictory. * \*\*Proteinuria thresholds are obtained from KDIGO guidelines and include moderate and severe levels of proteinuria\[47\]. 4. Females of childbearing potential must have a negative urine or serum pregnancy test prior to enrollment. 5. For patients in cohort 2: Patients who develop GVHD with any of the following characteristics and were not included in cohort 1 1. Grade III-IV aGVHD, or SR-aGVHD of any grade, whichever occurs first 2. Moderate to Severe cGVHD or SR-cGVHD of any grade, whichever occurs first 6. For patients in cohort 3: Patients included in either cohort 1 or 2 who are diagnosed with TA-TMA and receive eculizumab Exclusion Criteria: * Exclusion Criteria 1. Any other active malignancy requiring treatment or with expected survival ≤1 year. 2. Patients with psychiatric illness or social situations that would limit compliance with the study requirements.
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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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O'Neal Comprehensive Cancer Center at UAB
Birmingham, Alabama, 35294, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Massive UK study tracks cancer after organ transplants
- 10,000 transplant patients to be tracked for hidden heart risks
- Massive study to track stem cell patients in ICU
- Coloring away anxiety: mandala therapy eases stress for kidney transplant patients
- Personalized immune monitoring could transform liver transplant care
- Could a Plant-Based diet protect transplanted kidneys?