Cord blood stroke trial pulled before it even started
NCT ID NCT02460484
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study planned to test whether giving a child their own stored umbilical cord blood is safe for treating perinatal arterial ischemic stroke. It was designed for children aged 6 weeks to 6 years with MRI-confirmed stroke. The trial was withdrawn before enrolling any participants, so no results or conclusions are available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- autologous umbilical cord blood (the child's own stored cord blood)
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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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Start date
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Apr 2015
- Expected to finish
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Jun 2022
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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6 weeks to 6 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. Between 6 weeks and 6 years of age on the day of study cord blood infusion. 2. MRI documented single arterial distribution infarction. 3. Initial injury occurring in the prenatal or perinatal period 4. Ability of child and caregiver to travel to Orlando, and stay for at least 4 days, and to return for all Follow-up visits (patient is responsible for cost of travel and lodging while in Orlando) Exclusion Criteria: 1. Inability to obtain all pertinent medical records, including pertinent physician notes, laboratory findings, and radiographic images, related to the original injury, hospitalization and rehabilitation - must be sent to FHFC research team 14 days prior to scheduled study cord blood treatment. Need brain MRI with flair sequence \<2 weeks old. 2. Recent radiographic evidence (imaging performed within past 2 weeks) of extensive stroke as evidenced by \>100ml lesion 3. Multifocal infarctions on screening MRI. 4. Evidence of hypoxic-ischemic encephalopathy on screening MRI. 5. Uncorrected coagulopathy during the baseline period defined as INR \> 1.4; PTT\> 35 sec; PLT \< 100,000 6. Known history of: 1. Recently diagnosed infection (within past 2 weeks) requiring treatment and/or medical intervention 2. Renal disease or altered renal function as defined by serum creatinine \>1.5 mg/dL at admission 3. Hepatic disease or altered liver function as defined by SGPT \> 150 U/L, and/or T. Bilirubin \>1.3 mg/dL at enrollment 4. Malignancy 5. Immunosuppression as defined by WBC \< 3 (10x3) at admission 6. HIV 7. Any evidence of active maternal infection during the pregnancy (Hepatitis A, Hepatitis B, Hepatitis C, HIV 1, HIV 2, Human T-lymphotropic Virus (HTLV) 1, HTLV 2 8. Pneumonia, or chronic lung disease requiring oxygen 9. Cord blood sample contamination 10. Participation in a concurrent intervention study 11. Desire for organ-donation in the event of death 12. Unwillingness or inability to stay for at least four days following cord blood infusion (should any problems arise following the infusion) and to return for 6 month, and 1 year follow-up visits
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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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Florida Hospital for Children
Orlando, Florida, 32803, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.