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

NCT01343394 | Withdrawn Phase 1 DMC

• 1 other identifier: JB IND14312
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study are:

1. 1.To see if autologous human umbilical cord blood treatment is safe for children with acquired hearing loss, and
2. 2.To determine if late functional outcome is improved following autologous human umbilical cord blood treatment for children with acquired hearing loss.

Conditions

Hearing Loss

Keywords

Autologous; Stem Cells; Hearing Loss; Children

Outcome Measures

Primary Outcomes (1)

• Physiologic Outcome

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

  One year

Secondary Outcomes (1)

• Functional Outcome

  one year

Study Arms (1)

Biologic; Autologous Cell Injection

EXPERIMENTAL

Biological: Autologous Human Umbilical Cord Blood

Interventions

Autologous Human Umbilical Cord Blood BIOLOGICAL

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

Also known as: Autologous Human Umbilical Cord Blood Mononuclear Fraction Cells, Patient's Own Stem Cells

Biologic; Autologous Cell Injection

Eligibility Criteria

• Age: 6 Weeks - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aryn Knight: lead
• Cord Blood Registry, Inc.: collaborator
• The University of Texas Health Science Center, Houston: collaborator
• M.D. Anderson Cancer Center: collaborator
• Baylor College of Medicine: collaborator
• The Methodist Hospital Research Institute: collaborator
• Florida Hospital for Children: collaborator

Study Sites (1)

Children's Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: AVP Research

Study Record Dates

• First Submitted: April 25, 2011
• First Posted: April 28, 2011
• Study Start: April 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: April 1, 2016
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

US (1)