Safety of Autologous Human Umbilical Cord Blood Mononuclear Fraction to Treat Acquired Hearing Loss in Children
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hearing Loss
- Sponsor
- Aryn Knight
- Locations
- 1
- Primary Endpoint
- Physiologic Outcome
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
The objectives of this study are:
- To see if autologous human umbilical cord blood treatment is safe for children with acquired hearing loss, and
- To determine if late functional outcome is improved following autologous human umbilical cord blood treatment for children with acquired hearing loss.
Detailed Description
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.
Investigators
Aryn Knight
AVP Research
Memorial Hermann Health System
Eligibility Criteria
Inclusion Criteria
- •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).
Exclusion Criteria
- •Inability to obtain pertinent medical records.
- •Known history or
- •Recently treated ear or other infection.
- •Renal disease.
- •Hepatic disease.
- •Malignancy.
- •Immunosuppression (WBC \< 3,000).
- •Evidence of an extensive stroke (\> 100ml).
- •Pneumonia, or chronic lung disease.
- •hUCB sample contamination.
Outcomes
Primary Outcomes
Physiologic Outcome
Time Frame: One year
Age appropriate physiologic outcome measures will be recorded pre-treatment, and one year following hUCB treatment
Secondary Outcomes
- Functional Outcome(one year)