Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT01343394
Eligibility Criteria:
Inclusion Criteria:
1. Evidence of a moderate to profound sensorineural hearing loss.
2. Normally shaped cochlea, as determined by MRI.
3. The loss must be considered acquired, NOT syndromic.
4. The patient must be fitted for hearing aids of the detection of the loss.
5. Enrollment in a parent/child intervention program.
6. Between 6 weeks and 18 months of age at the time of cord blood infusion.
7. 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).
Exclusion Criteria:
1. Inability to obtain pertinent medical records.
2. 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.
3. hUCB sample contamination.
4. Participation in a concurrent intervention study.
5. Desire for organ donation in the event of death.
6. 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.
7. Presence of a cochlear implant device.
8. Evidence of a syndrome.
9. Positive test for genetic hearing loss.
10. Evidence of conductive hearing loss.
11. Documented evidence of recurrent middle ear infections (\> 5/year).
12. Otitis media at the time of examination.
13. Mild sensorineural hearing loss.
14. Over 18 months at the time of infusion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Weeks
Maximum Age:
18 Months
Study:
NCT01343394
Study Brief:
Protocol Section:
NCT01343394