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