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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|