Safety of Autologous Stem Cell Infusion for Children With Acquired Hearing Loss
|ClinicalTrials.gov Identifier: NCT02038972|
Recruitment Status : Completed
First Posted : January 17, 2014
Last Update Posted : March 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Sensorineural Hearing Loss||Genetic: Autologous Stem Cells||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety of Autologous Stem Cell Infusion for Children With Acquired Hearing Loss|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||December 11, 2015|
|Actual Study Completion Date :||January 10, 2017|
Experimental: Autologous Stem Cells
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.
Genetic: Autologous Stem Cells
The subjects autologous stem cells banked at Cord Blood Registry will be infused intravenously by gravity.
Other Name: Cell based therapy
- Safety of Autologous Stem Cell Infusion [ Time Frame: 1 year ]
To determine if autologous human umbilical cord blood (hUBC) infusion in children with hearing loss is safe and feasible. Infusion related toxicity as measured by:
i. hemodynamic instability: An adverse event will be defined as a sustained (> 10 minutes) >20% decrease in MAP.
ii. acute lung injury: Chest X-ray will be done at baseline and at 1 day post infusion to assess for polymorphonuclear infiltrates iii. hepatic injury/toxicity: Hepatic panel will be performed at baseline and 1 day post infusion. Injury is defined as acute elevation of the AST/ALT hepatic enzymes > 900 U/dl in the first 24 hours post infusion iv. renal injury/insufficiency: CMP will be performed at baseline and 1 day after infusion v. exacerbation of neurological status: defined as a change in Glasgow Coma Scale, pupillary size/reactivity, motor/sensory evaluation of extremities, and seizure activity from infusion to discharge.
- Inner Ear Function, Audition, and Language Development [ Time Frame: 1 year ]To determine if autologous hUBC transplantation in children with hearing loss improves inner ear function, audition and language development.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02038972
|United States, Florida|
|Orlando, Florida, United States, 32803|
|Principal Investigator:||James Baumgartner, MD||Florida Hospital|