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

This study is currently recruiting participants.

Verified April 2011 by Memorial Hermann Healthcare System

First Received on April 25, 2011. Last Updated on May 19, 2011 History of Changes

Sponsor:	Memorial Hermann Healthcare System
Collaborators:	Cord Blood Registry Speech Therapists for Children The University of Texas Health Science Center, Houston M.D. Anderson Cancer Center Baylor College of Medicine The Methodist Hospital System Research Institute - Houston
Information provided by:	Memorial Hermann Healthcare System
ClinicalTrials.gov Identifier:	NCT01343394

Purpose

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	Intervention	Phase
Hearing Loss	Biological: Autologous Human Umbilical Cord Blood	Phase 1

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Safety of Autologous Human Umbilical Cord Blood Mononuclear Fraction to Treat Acquired Hearing Loss in Children

Resource links provided by NLM:

Genetics Home Reference related topics: nonsyndromic deafness

MedlinePlus related topics: Hearing Disorders and Deafness

U.S. FDA Resources

Further study details as provided by Memorial Hermann Healthcare System:

Primary Outcome Measures:

Physiologic Outcome [ Time Frame: One year ] [ Designated as safety issue: No ]
Age appropriate physiologic outcome measures will be recorded pre-treatment, and one year following hUCB treatment

Secondary Outcome Measures:

Functional Outcome [ Time Frame: one year ] [ Designated as safety issue: No ]
Age approriate Speech-Language assessments will be performed pre-treatment and one year post-treatment.

Estimated Enrollment:	10
Study Start Date:	April 2011
Estimated Study Completion Date:	April 2015
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Intervention Details:

6 million cells/kg will be administered intravenously at one treatment time point.

Other Names:

Autologous Human Umbilical Cord Blood Mononuclear Fraction Cells
Patient's Own Stem Cells

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.

Eligibility

Ages Eligible for Study:	6 Weeks to 18 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.
- HIV.
- 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01343394

Contacts

Contact: Inge E. Wieser, RN, CCRC	713-704-6928	Ingeborg.Wieser@memorialhermann.org
Contact: Amy Waller, PA-C	713-704-3279	Amy.Waller@memorialhermann.org

Locations

United States, Texas
Children's Memorial Hermann Hospital	Recruiting
Houston, Texas, United States, 77030

Sponsors and Collaborators

Memorial Hermann Healthcare System

Cord Blood Registry

Speech Therapists for Children

The University of Texas Health Science Center, Houston

M.D. Anderson Cancer Center

Baylor College of Medicine

The Methodist Hospital System Research Institute - Houston

Investigators

Principal Investigator:	James E. Baumgartner, MD	Memorial Hermann Health System
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

More Information

No publications provided

Responsible Party:	James Baumgartner, Pediatric Neurosurgical Specialists-Memorial Hermann Healthcare System
ClinicalTrials.gov Identifier:	NCT01343394 History of Changes
Other Study ID Numbers:	JB IND14312
Study First Received:	April 25, 2011
Last Updated:	May 19, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Memorial Hermann Healthcare System:

Autologous
Stem Cells
Hearing Loss
Children

Additional relevant MeSH terms:

Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases

Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2012