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Autologous Bone Marrow Harvest and Transplant for Sensorineural Hearing Loss

NCT02616172 · Status: SUSPENDED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-03-18

No results posted yet for this study

Summary

Autologous human bone marrow mononuclear fraction (BMMF) will be harvested and given to children with bilateral moderate to severe sensorineural hearing loss. The aim is to determine if bone marrow mononuclear fraction (BMMF) infusion is safe, feasible, improves inner ear function, audition, and language development.

Conditions

  • Sensorineural Hearing Loss

Interventions

GENETIC

Autologous Bone Marrow Infusion

The subjects autologous bone marrow cells harvested at Florida Hospital will be infused intravenously by gravity

Sponsors & Collaborators

  • James Baumgartner, MD

    lead OTHER

Principal Investigators

  • James Baumgartner, MD · AdventHealth

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2022-09-30
Completion
2022-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02616172 on ClinicalTrials.gov