Could a Child's own cord blood stem cells restore hearing?
NCT ID NCT02038972
First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time
Summary
This study tests whether infusing a child's own stored umbilical cord blood stem cells is safe for children with acquired sensorineural hearing loss. The trial enrolls children with moderate to profound hearing loss and aims to see if the infusion can improve inner ear function, hearing, and language development. It is an early-stage safety study involving 11 participants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- autologous stem cells from cord blood
- What this could lead to
- If safe and effective, this approach could offer a way to improve inner ear function and language development in children with acquired hearing loss.
- What could go wrong
- This is a very early Phase 1 safety trial with only 11 children. It is not designed to prove the treatment works, and there is no guarantee of hearing improvement.
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
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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11 people
The number who actually took part.
- Start date
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Jan 2013
- Finished
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Jan 2017
- 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
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6 weeks to 6 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: 1. Evidence of a sensorineural hearing loss * Unilateral or bilateral in configuration * Symmetrical or asymmetrical configuration * Sudden or progressive in presentation * Moderate to profound in degree (40-90 Decibels (dB) in at least one ear 2. Normally shaped cochlea, as determined by MRI 3. The loss must be considered: * Acquired * Unknown with a negative genetic test. 4. Fitted for hearing aids no later than six months post detection of loss. 5. Enrollment in a parent/child intervention program 6. Age 6 weeks - 6 years old at time of infusion with less than 18 months of hearing loss at the time of cord blood infusion. 7. Ability of the child and caregiver to travel to Orlando, and stay for at least 4 days, and to return for all follow-up visits. Exclusion Criteria 1. Inability to obtain all pertinent medical records: * (pertinent physician notes, speech language pathology notes, laboratory findings, test results and imaging studies-must be sent to the research team at least prior to the subject arriving at the study location for preliminary screening and eligibility assessment, preferably14 days before the scheduled hUBC treatment.) 2. Known history of: * Recently treated infection less than 2 weeks before infusion. * Renal disease of altered renal function as defined by serum creatinine \> 1.5 mg/dl at admission. * Hepatic disease or altered liver function as defined by SGPT \> 150 U/L, and or T. Bilirubin \> 1.3 mg/dL * Malignancy * Immunosuppression as defined by WBC \< 3,000 at admission * Human Immunodeficiency Virus (HIV) * Hepatitis B * Hepatitis C * Evidence of an extensive stroke (\> 100ml lesion) * Pneumonia, or chronic lung disease requiring oxygen * Genetic syndromic sensorineural hearing loss 3. hUBC sample contamination 4. Banked cord cells totaling less than 6x106 mononuclear cells/kilogram body weight. 5. Evidence of the following maternal infections during the pregnancy (Hepatitis A, Hepatitis B, Hepatitis C, HIV 1, HIV 2, Human T-lymphotropic Virus (HTLV) 1, HTLV 2 (CMV and Syphilis can be included in the study) 6. participation in a concurrent intervention study 7. Unwillingness or inability to stay for 4 days following hUBC infusion (should problems arise following the infusion) and to return for the one month, six month and one year follow-up visits. 8. Presence of a cochlear implantation device 9. Evidence of a genetic syndrome 10. Evidence of conductive hearing loss 11. Documented recurrent middle ear infections which are frequent (\>5 per year) 12. Otitis media at the time of examination 13. Sensorineural loss is mild 14. Over 18 months from identification of hearing loss at time of infusion
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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
Orlando, Florida, 32803, United States
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Other studies related to the condition(s) this trial covers.
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