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

Related Clinical Trial
Implantation of the Cochlear™ Nucleus® Hybrid S Round Window (S-RW) in Adults Anatomy-Based Fitting in Unexperienced Cochlear Implant Users Effect of Modulated Auditory Stimulation on Interaural Auditory Perception Effect of Donepezil on Speech Recognition in Cochlear Implant Users Analysis of Risk Factors of Neurodevelopmental Disorder in Deaf Infants Under Ten Months of Age. Natural History in Children up to 10 Years With Moderate to Profound Hearing Loss Due to Mutations in GJB2/OTOF Genes Evaluation of Electrode-modiolus Distance and Cochlear Fibrosis Using Depth Sounding and Spectroscopy Tools Audiological and Quality of Life Outcomes of Anatomy Based Fitting in Patients Implanted by Robot Assisted Cochlear Implant Surgery (RACIS) Pupillometry Techniques Usage to Quantify the Programming Parameters Effect in the Auditory Effort in Zti Opticon Cochlear Implant Adult Users Factors Affecting Early Progress of Cochlear Implant Outcomes in Adults Study of Sound and Speech Perception in New Cochlear Implanted Subjects Using or Not an Anatomy-based Fitting Post Approval Study to Assure the ContInued saFety and effectIveness of Neuro Cochlear Implant System in Adult Users Quantification of Visually Evoked Cortical Potentials in Individuals With Hearing Loss A Trial of LY3056480 in Patients With SNLH Fundamental Asynchronous Stimulus Timing Sound Coding Study Phase I Clinical Study of HY01 in Patients Genotype-phenotype Correlation of SLC26A4 in CI Patients With EVA Study of Music and Speech Perception in New Cochlear Implanted Subjects Using or Not a Tonotopy Based Fitting Oral Statins and Protection From Hearing Loss Study of a Minimally Invasive Cochlear Access for Cochlear Implantation Via a Robotic Procedure Cochlear Implant With Dexamethasone Eluting Electrode Array Hearing Implant Performance in Adults With Low-Frequency Residual Hearing Perimodiolar Implant Performance in Adults With Low-Frequency Residual Hearing Cochlear Implanted Listening Effort and Hearing Attention The Performance of a Robot-assisted Minimally Invasive Direct Cochlear Access for Cochlear Implantation Auditory Performances With Different Stimulation Depths in Cochlear Implanted Subjects Using a Fine Structure Strategy Feasibility of the Mi2000 Totally Implantable Cochlear Implant in Severely to Profoundly Deaf Adults. Hearing Aid Noise Reduction in Pediatric Users Pilot Study (Oticon Pilot Study) Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss Dexamethasone-Eluting Cochlear Implant Electrode Artificial Intelligence in Diagnosis of DFNA9 Randomized Controlled Trial of Valganciclovir for Cytomegalovirus Infected Hearing Impaired Infants Study to Determine the Safety, Tolerability, and Pharmacokinetic Profile of HPN-07 and HPN-07 Plus NAC Cochlear Implant and Vestibular Function. Quality Control of CE-Certified Phonak Hearing Aids – 2018_42 Quality Control of CE-Certified Phonak Hearing Aids – 2018_28 Enlarged Vestibular Aqueduct Registry Evaluation of the High Frequency Digit Triplet Test in Cystic Fibrosis Effectiveness of P02 Digital Hearing Aids ABR Characteristics and Salivary Cortisone Concentration in Noise-exposed Workers Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population Genetic Analysis of Hereditary Disorders of Hearing and Balance Compassionate Use Arm – ABI541 ABI for 10 NF2 Patients Evaluation of a Binaural Beamformer (StereoZoom) in a Virtual Acoustic Environment and in Real Life Evaluation of N6 Sound Processor in Group of Freedom Users Robotic Assisted Cochlear Implantation Feasibility Study Auditory Nerve Test System During Vestibular Schwannoma Resection Cochlear Electrical Impedance and the Effect of Topical Dexamethasone on Cochlear Implant Surgery Comparison Between Neuro 1 and Neuro 2 Cochlear Implant Speech Processors Listening Effort in Cochlear Implant Users Quality Control of CE-Certified Phonak Hearing Aids – 2019_19 Esteem Totally Implantable Hearing System A Clinical Trial of Anakinra for Steroid-Resistant Autoimmune Inner Ear Disease Study of Quality Perception on Music in New Cochlear Implanted Subjects Using or Not a Fine Structure Strategy An Evidence Based Delivery Model of Care for Newly Implanted Adult CI Recipients Study of Auditory Performance on Prosodic Tests in Cochlear Implanted Subjects Using a Fine Structure Strategy CI532 – Early Experience Study Clinical Applications of Round Window Imaging Anatomy in Cochlear Implant Surgery Single-sided Deafness and Cochlear Implants Cochlear Implantation Among Adults and Older Children With Unilateral or Asymmetric Hearing Loss Clinal Evaluation of Navigation Based Functional Ear Surgery Using Image Guided and Robotically Assisted Techniques OTO-413 in Subjects With Speech-in-Noise Hearing Impairment The Efficacy of a Minimally Invasive Direct Cochlear Access Via the HEARO Procedure Clinical Evaluation of a Cochlear Implant System Objective Measures in Cochlear Implant Evaluation of a Binaural Spatialization Method for Hearing Aids Esteem New Subject Enrollment Post Approval Study Safety of Autologous Stem Cell Infusion for Children With Acquired Hearing Loss Investigation of Anatomical Correlates of Speech Discrimination Efficacy of Digital Noise Reduction Strategies: A Hearing Aid Trial Evaluation of Revised Indicatons (ERID) for Cochlear Implant Candidacy for the Adult CMS Population Clinical and Genetic Analysis of Enlarged Vestibular Aqueducts Balance in Children With Cochlear Implants Congenital Cytomegalovirus: Efficacy of Antiviral Treatment Nucleus Freedom Cochlear Implant System Pediatric Post-approval Study Evaluation of the Nucleus Hybrid™ L24 Cochlear Implant System Radiological Classification of the Facial Nerve Congenital Cytomegalovirus: Efficacy of Antiviral Treatment in a Randomized Controlled Trial The Effect of Sound Stimulation on Hearing Ability The Effect of Sound Stimulation on Pure-tone Hearing Threshold Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss The SeaSHeL National Prospective Cohort Study Non-linear Frequency Compared to Conventional Processing in Patients With and Without Cochlear Dead Regions. Study of Low Level Laser Therapy and Word Recognition in Hearing Impaired Individuals Electrode Placement and Audiologic Outcomes With the Advanced Bionics HiFocus L23 Electrode Video HIT in Sudden Sensorineural Hearing Loss Determine the Incidence of Long QT Amongst a Large Cohort of Subjects Diagnosed With Unilateral or Bilateral Sensorineural Hearing Loss. FX-322 in Sensorineural Hearing Loss Autologous Bone Marrow Harvest and Transplant for Sensorineural Hearing Loss FX-322 in Adults With Stable Sensorineural Hearing Loss

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

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


Primary Outcome

Safety of Autologous Stem Cell Infusion

Secondary Outcome

 Inner Ear Function, Audition, and Language Development


Sensorineural Hearing Loss


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.


* 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


Estimated Enrollment


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




6 Weeks - 6 Years

Accepts Healthy Volunteers



James Baumgartner, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Responsible Party


Study Sponsor

James Baumgartner, MD


 CBR Systems, Inc.

Study Sponsor

James Baumgartner, MD, Principal Investigator, AdventHealth

Verification Date

August 2017