Stem cell trial for rare bleeding disorder pulled before it began
NCT ID NCT06813157
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study planned to test whether infusions of mesenchymal stem cells could safely help people with refractory immune thrombocytopenia (ITP), a condition where the immune system destroys platelets, causing bleeding. The trial was withdrawn before enrolling any participants, so no results are available. It would have given five stem cell infusions over several weeks and tracked platelet counts and bleeding for a year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mesenchymal stem cells (MSCs)
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.
- Started
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Nov 2024
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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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4 to 75 years
- Sex
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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 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: 1. The subjects voluntarily signed the informed consent form; 2. The age is from 4 to 75 years old (including the critical value), male or female; 3. Patients clinically diagnosed as ITP (meeting the diagnostic criteria of the Chinese guidelines for the diagnosis and treatment of Primary immune Thrombocytopenia in Adults (2020 Edition)) had persistent thrombocytopenia for more than 3 months, but were ineffective to first-line drugs, second-line drugs for platelet production and rituximab, or ineffective to splenectomy / recurrence after operation. 4. Patients who received other maintenance regimens (including but not limited to corticosteroids, azathioprine, danazol or mycophenolate mofetil), but the stable dose had been maintained for at least 4 weeks, and the dose should remain unchanged during the trial period; 5. During screening, the liver and kidney function of the subjects met the following criteria: alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST) ≤ 3 times of the upper limit of the normal value; total bilirubin ≤ 1.5 times of the upper limit of the normal value; creatinine ≤ 1.5 times of the upper limit of the normal value or creatinine clearance rate \& gt; 75ml / min; 6. Women of childbearing age must have negative blood or urine pregnancy tests and are not breast-feeding, and agree to use medically approved contraceptive measures (such as intrauterine devices, condoms or contraceptive) during the study period. 7. Fertile male patients must agree to use barrier contraception or physical abstinence during the study; 8. The subjects were able to understand the nature and purpose of the trial, including possible risks and side effects, and to understand the researchers' oral and written medical orders and comply with the requirements of the trial. Exclusion Criteria: 1. Have a history of severe allergic diseases or are allergic to research drugs; 2. There may be a history of angina pectoris, myocardial infarction, heart failure, severe arrhythmia, etc. 3. Combined use of anticoagulants or antiplatelet drugs; 4. In the first study, he was treated with gamma globulin within 2 weeks before medication. 5. The first study received rituximab within 24 weeks before treatment; 6. Other clinical trial drugs were used within 1 month before the use of drugs in the first study. 7. Uncontrolled hypertension (blood pressure is still higher than 160/100mmHg after active treatment); 8. Have a history of malignant tumor; 9. Those with a history of hepatitis B, or hepatitis C, or HIV, or immunodeficiency, or positive results of laboratory tests (hepatitis B surface antigen, or hepatitis C antibody, or HIV antibody) during screening; 10. Active / latent tuberculosis infection or other pathogen infection; 11. Live attenuated vaccine was vaccinated within 1 month before drug use in the first study, or there was a live attenuated vaccine program during the study period; 12. Hypogammaglobulinemia (IgG\<400mg/dl) or IgA deficiency (IgA\<10mg/dl); 13. History of important organ transplantation; 14. Patients with a history of severe mental illness; 15. The researchers believe that it is not appropriate for patients to participate in other conditions of this trial.
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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.
Contacts and locations
Locations
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Dongguan Taixin Hospital
Guangdong, Guangdong, 523125, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Triple-Drug attack tame immune thrombocytopenia?
- New combo therapy aims to boost platelets in ITP patients
- Gene-Edited immune cells take on autoimmune blood diseases
- New combo aims to free ITP patients from lifelong medication
- New drug OM336 aims to tame overactive immune system
- Promising ITP drug trial pulled before it even started