Safety of Autologous Human Umbilical Cord Blood Mononuclear Fraction to Treat Acquired Hearing Loss in Children
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|ClinicalTrials.gov Identifier: NCT01343394|
Recruitment Status : Suspended (UT-IRB insists on protocol design change -Not rel to any pt. safety/non-compliance-Recruiting halted at UT/MHHS but may resume at FLHosp for Children-OrlandoFL)
First Posted : April 28, 2011
Last Update Posted : January 23, 2014
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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.
|Condition or disease||Intervention/treatment||Phase|
|Hearing Loss||Biological: Autologous Human Umbilical Cord Blood||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety of Autologous Human Umbilical Cord Blood Mononuclear Fraction to Treat Acquired Hearing Loss in Children|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||January 2013|
|Estimated Study Completion Date :||April 2016|
|Experimental: Biologic; Autologous Cell Injection||
Biological: Autologous Human Umbilical Cord Blood
6 million cells/kg will be administered intravenously at one treatment time point.
- Physiologic Outcome [ Time Frame: One year ]Age appropriate physiologic outcome measures will be recorded pre-treatment, and one year following hUCB treatment
- Functional Outcome [ Time Frame: one year ]Age appropriate Speech-Language assessments will be performed pre-treatment and one year post-treatment.
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|Ages Eligible for Study:||6 Weeks to 18 Months (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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).
- Inability to obtain pertinent medical records.
Known history or
- Recently treated ear or other infection.
- Renal disease.
- Hepatic disease.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01343394
|United States, Texas|
|Children's Memorial Hermann Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||James E. Baumgartner, MD||MHHS, Houston,TX & FL Hospital for Children, Orlando, FL|
|Principal Investigator:||Linda S. Baumgartner, CCC-SLP, LSLS CERT.AVT||Speech Therapists for Children|
|Principal Investigator:||Samir Fakhri, MD||The University of Texas Health Science Center, Houston|
|Responsible Party:||James E.Baumgartner, MD, Board-certified Pediatric Neurosurgeon, Memorial Hermann Health System|
|Other Study ID Numbers:||
|First Posted:||April 28, 2011 Key Record Dates|
|Last Update Posted:||January 23, 2014|
|Last Verified:||January 2014|
Nervous System Diseases