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Cord blood stroke trial pulled before it even started

NCT ID NCT02460484

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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 The trial was withdrawn before enrolling any participants, so no results or conclusions are available.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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Start date

Apr 2015

Expected to finish

Jun 2022

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

6 weeks to 6 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: 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

  • Florida Hospital for Children

    Orlando, Florida, 32803, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.