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Schwann Cell IND
Progress

 


~Organized Schwann cell clinical trial team

 


~Obtained guidance from external SCI experts and FDA consultants

 


~Held informal discussion with the FDA

 


~Developed GMP cell processing and manufacturing procedures for human Schwann cells

 

~Performed toxicology and tumorigenicity experiments in rodents

 

~Designed the safest procedures for injecting cells

 

 

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Home > Research Clinical Trials & Studies > Subacute Schwann Cell Clinical Trial

 

 

Clinical Trial for Subacute Spinal Cord Injury

This trial is an FDA-approved Phase I clinical trial designed to test the safety of autologous human Schwann cells in subjects with subacute spinal cord injury.

 

 

Subject inclusion criteria:

• Persons with traumatic spinal cord injury (SCI) that occurred within the previous 30 days;

• Between the ages of 18 and 60 years at last birthday;

• SCI at thoracic level between T3-T11 as defined by MRI and the most caudal level of intact motor and sensory function;

• No movement or sensation below the level of injury at the time of enrollment.

 

 

 

Subject exclusion criteria:

 

• Persons with penetrating injury of the spinal cord or complete transection of the cord, including bone fragment lacerations, as identified by MRI;

• Persons with a lesion in the conus medullaris, cauda equine, or lower extremity peripheral nerve;

• Other traumatic injuries (e.g. Closed Head Injury, another level of SCI) affecting the ability to provide informed consent and participate fully in rehabilitation;

• Presence of systemic disease that might interfere with subject safety, compliance, or evaluation of the condition under study;

• Body Mass Index (BMI)> 35;

• Persons with significant lower extremity injury, previous surgery, or amputation such that would preclude satisfactory sural nerve harvest;

 

 

 

For more information:


If you have a loved one or a patient whom you think
may qualify for this study, contact:


The Miami Project to Cure Paralysis
            as soon as possilbe at (305) 243-7108. 
         

                                          

 

  

For additional information, please visit: 

 

 

 

 

 

 

 

 

 

 

Video Message from Drs. Levi and Guest

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
 
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