Safety of Autologous Stem Cell Infusion for Children With Acquired Hearing Loss
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.
Sensorineural Hearing Loss
Genetic: Autologous Stem Cells
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety of Autologous Stem Cell Infusion for Children With Acquired Hearing Loss|
- Safety of Autologous Stem Cell Infusion [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
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: Heapitc 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 ] [ Designated as safety issue: No ]To determine if autologous hUBC transplantation in children with hearing loss improves inner ear function, audition and language development.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02038972
|Contact: Linda Baumgartner, MSfirstname.lastname@example.org|
|Contact: Jennifer Green, DNP, ARNP||407-388-5715||Jennifer.email@example.com|
|United States, Florida|
|Orlando, Florida, United States, 32803|
|Contact: Jennifer Green, DNP, ARNP 407-388-5715 firstname.lastname@example.org|
|Principal Investigator:||James Baumgartner, MD||Florida Hospital|
|Principal Investigator:||Linda Baumgartner, MS||Florida Hospital|