Safety of Autologous Stem Cell Infusion for Children With Acquired Hearing Loss

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Brief Title

Safety of Autologous Stem Cell Infusion for Children With Acquired Hearing Loss

Official Title

Safety of Autologous Stem Cell Infusion for Children With Acquired Hearing Loss

Brief Summary

      To determine if autologous human umbilical cord blood infusion in children with acquired
      hearing loss is safe, feasible, improves inner ear function, audition and language
      development.
    

Detailed Description

      There is currently no treatment available to repair/reverse acquired sensorineural hearing
      loss. Recent experiments using human umbilical cord blood treatment of a mouse and guinea pig
      models have demonstrated hair cell re-growth following acquired sensorineural loss as well as
      partial restoration of ABR. Autologous human umbilical cord blood therapy, which has been
      used for over twenty years, has an excellent safety record. This study will determine if
      autologous human umbilical cord blood infusion in children with hearing loss is safe and
      feasible, improves inner ear function, audition, and language development. The patients
      umbilical cord stem cells collected at birth and stored at Cord Blood Registry will be used
      for infusion.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Safety of Autologous Stem Cell Infusion

Secondary Outcome

 Inner Ear Function, Audition, and Language Development

Condition

Sensorineural Hearing Loss

Intervention

Autologous Stem Cells

Study Arms / Comparison Groups

 Autologous Stem Cells
Description:  A single dose of intravenously administered autologous hUCB will be done. The minimum acceptable dose will be 6x10 6th mononuclear cells/kilogram body weight. The hUCB reanimation, cell processing and product infusion will occur at Florida Hospital for Children and the Florida Hospital Center for Cellular Therapy.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Genetic

Estimated Enrollment

11

Start Date

January 2013

Completion Date

January 10, 2017

Primary Completion Date

December 11, 2015

Eligibility Criteria

        Inclusion Criteria:

          1. Evidence of a sensorineural hearing loss

               -  Unilateral or bilateral in configuration

               -  Symmetrical or asymmetrical configuration

               -  Sudden or progressive in presentation

               -  Moderate to profound in degree (40-90 Decibels (dB) in at least one ear

          2. Normally shaped cochlea, as determined by MRI

          3. The loss must be considered:

               -  Acquired

               -  Unknown with a negative genetic test.

          4. Fitted for hearing aids no later than six months post detection of loss.

          5. Enrollment in a parent/child intervention program

          6. Age 6 weeks - 6 years old at time of infusion with less than 18 months of hearing loss
             at the time of cord blood infusion.

          7. Ability of the child and caregiver to travel to Orlando, and stay for at least 4 days,
             and to return for all follow-up visits.

        Exclusion Criteria

          1. Inability to obtain all pertinent medical records:

               -  (pertinent physician notes, speech language pathology notes, laboratory findings,
                  test results and imaging studies-must be sent to the research team at least prior
                  to the subject arriving at the study location for preliminary screening and
                  eligibility assessment, preferably14 days before the scheduled hUBC treatment.)

          2. Known history of:

               -  Recently treated infection less than 2 weeks before infusion.

               -  Renal disease of altered renal function as defined by serum creatinine > 1.5
                  mg/dl at admission.

               -  Hepatic disease or altered liver function as defined by SGPT > 150 U/L, and or T.
                  Bilirubin > 1.3 mg/dL

               -  Malignancy

               -  Immunosuppression as defined by WBC < 3,000 at admission

               -  Human Immunodeficiency Virus (HIV)

               -  Hepatitis B

               -  Hepatitis C

               -  Evidence of an extensive stroke (> 100ml lesion)

               -  Pneumonia, or chronic lung disease requiring oxygen

               -  Genetic syndromic sensorineural hearing loss

          3. hUBC sample contamination

          4. Banked cord cells totaling less than 6x106 mononuclear cells/kilogram body weight.

          5. Evidence of the following maternal infections during the pregnancy (Hepatitis A,
             Hepatitis B, Hepatitis C, HIV 1, HIV 2, Human T-lymphotropic Virus (HTLV) 1, HTLV 2
             (CMV and Syphilis can be included in the study)

          6. participation in a concurrent intervention study

          7. Unwillingness or inability to stay for 4 days following hUBC infusion (should problems
             arise following the infusion) and to return for the one month, six month and one year
             follow-up visits.

          8. Presence of a cochlear implantation device

          9. Evidence of a genetic syndrome

         10. Evidence of conductive hearing loss

         11. Documented recurrent middle ear infections which are frequent (>5 per year)

         12. Otitis media at the time of examination

         13. Sensorineural loss is mild

         14. Over 18 months from identification of hearing loss at time of infusion
      

Gender

All

Ages

6 Weeks - 6 Years

Accepts Healthy Volunteers

No

Contacts

James Baumgartner, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02038972

Organization ID

434269


Responsible Party

Sponsor-Investigator

Study Sponsor

James Baumgartner, MD

Collaborators

 CBR Systems, Inc.

Study Sponsor

James Baumgartner, MD, Principal Investigator, Florida Hospital


Verification Date

August 2017