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Safety of Autologous Human Umbilical Cord Blood Mononuclear Fraction to Treat Acquired Hearing Loss in Children

Phase 1
6 Weeks
18 Months
Not Enrolling
Hearing Loss

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Trial Information

Safety of Autologous Human Umbilical Cord Blood Mononuclear Fraction to Treat Acquired Hearing Loss in Children

Acquired sensorineural hearing loss is characterized by a loss of functioning hair cells in
the Organ of Corti, with greater hair cell loss correlating with more severe hearing
impairment. Children with sensorineural hearing loss experience difficulty developing normal
language which usually leads to poor academic and social development. Currently, there are
no reparative therapeutic options available, and treatments are designed to augment the
diminished function of the injured Organ of Corti.

Pre-clinical data suggest progenitor cell infusions may enhance intrinsic repair mechanisms
in the Organ of Corti which may restore hair cells. This treatment could ultimately lead to
hearing improvement. Human umbilical cord blood (hUCB) is an available, autologous, stored
progenitor cell population available for potential therapeutic use. The primary objective of
this study is to determine the safety of autologous hUCB infusion in children with acquired
hearing loss. The secondary objective is to determine if functional, physiologic and
anatomic outcomes are improved following hUCB treatment in this patient population.

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Physiologic Outcome

Outcome Description:

Age appropriate physiologic outcome measures will be recorded pre-treatment, and one year following hUCB treatment

Outcome Time Frame:

One year

Safety Issue:


Principal Investigator

James E. Baumgartner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Hermann Health System


United States: Food and Drug Administration

Study ID:

JB IND14312



Start Date:

April 2011

Completion Date:

April 2015

Related Keywords:

  • Hearing Loss
  • Autologous
  • Stem Cells
  • Hearing Loss
  • Children
  • Hearing Loss
  • Deafness



Children's Memorial Hermann Hospital Houston, Texas  77030