Safety of Autologous Human Umbilical Cord Blood Mononuclear Fraction to Treat Acquired Hearing Loss in Children
Withdrawn before enrolling · Phase 1
Conditions studied: Hearing Loss
In brief
The objectives of this study are: 1. To see if autologous human umbilical cord blood treatment is safe for children with acquired hearing loss, and 2. To determine if late functional outcome is improved following autologous human umbilical cord blood treatment for children with acquired hearing loss.
Key facts
- Study ID
- NCT01343394
- Run by
- Aryn Knight
- People needed
- 0
- Starts
- 2011-04-01
- Expected to finish
- 2016-04-01
- Last updated by the study team
- 2024-03-20
Who can join
Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Evidence of a moderate to profound sensorineural hearing loss.
- Normally shaped cochlea, as determined by MRI.
- The loss must be considered acquired, NOT syndromic.
- The patient must be fitted for hearing aids of the detection of the loss.
- Enrollment in a parent/child intervention program.
- Between 6 weeks and 18 months of age at the time of cord blood infusion.
- Ability of child and caregiver to travel to Houston for treatment and all follow-up appointments. (Patient's family is responsible for the cost of travel to and lodging in Houston).
You may not qualify if…
- Inability to obtain pertinent medical records.
- Known history or
- Recently treated ear or other infection.
- Renal disease.
- Hepatic disease.
- Malignancy.
- HIV.
- Immunosuppression (WBC < 3,000).
- Evidence of an extensive stroke (> 100ml).
- Pneumonia, or chronic lung disease.
- hUCB sample contamination.
- Participation in a concurrent intervention study.
- Desire for organ donation in the event of death.
- Unwillingness or inability to stay 4 days following hUCB infusion, and to return for the one month, six month and one year follow-up visits.
- Presence of a cochlear implant device.
- Evidence of a syndrome.
- Positive test for genetic hearing loss.
- Evidence of conductive hearing loss.
- Documented evidence of recurrent middle ear infections (> 5/year).
- Otitis media at the time of examination.
- Mild sensorineural hearing loss.
- Over 18 months at the time of infusion.
Where it is running
- Children's Memorial Hermann Hospital — Houston, Texas, United States
Full record on ClinicalTrials.gov
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