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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

 

 

Read more...

 

  

 

 

 


Who qualifies for the Schwann cell clinical trial?
 

 

 

 

Home > Research > Clinical Trials & Studies

 

 

 

CLINICAL TRIALS & STUDIES

 

The Miami Project clinical researchers currently have several clinical trials and clinical studies available for people who have had a spinal cord injury; some are for acute injuries and some are for chronic injuries.  The clinical trials are testing the safety and efficacy of different neuroprotective, repairative, or modulatory interventions.  The clinical studies are investigating questions regarding exercise science, nutrition, rehabilitation training, pain, male fertility, aging, and brain-machine interface technology.
 
If you would like to be considered for these or future Miami Project trials or studies, please see our Interested in Participating? page, send us a message , or call the Miami Project Education Office at 305-243-7108. 

 

 

TREATMENT

POPULATION

PRE-CLINICAL

PHASES

1

2

AUTOLOGOUS SCHWANN CELLS

Acute SCI

 

Enrolling

 

Chronic SCI

 

Pending

 

BIOMARKERS

OF SCI

Acute SCI

 

Enrolling

 

 

NACTN

Acute SCI

 

Enrolling

 

 

RILUZOLE

Acute SCI

 

Completed

Pending

 

AC105

Acute SCI

   


Pending

 

THERAPEUTIC

HYPOTHERMIA

Acute SCI

 

Enrolling

Pending

HuCNS-SC® STEM CELLS

Chronic SCI

   

Enrolling

 

 

  

 

(Click each one of the topics below for additional study details)

TOPIC

STUDY

Survey #1

International Spinal Cord Injury Basic Pain Data Set Survey forSelf-Report Measure

Survey #2


  Survey About Pain After Spinal Cord Injury

Activity
and
Nutrient Modifying

Cardiometabolic Risk, Obesity and Cardiovascular Disease in People with Spinal Cord Injury

Effect of an Omega-3 Supplement Intervention Program on Cardiometabolic Health in People with Spinal Cord Injury

Obesity/Overweight in Persons with Early and Chronic SCI: A Randomized Multi-Center Controlled Lifestyle Intervention 

Clinically Meaningful Changes in Wheelchair Propulsion Stress

Training Programs to Improve Outcomes for Individuals with Spinal Cord Injury

Assessment of Novel Fitness Tests and Fitness Intervention

Male Fertility

Fertility Evaluation

Treatment of Infertility

Rehabilitation

Skilled Motor Training and tDCS to Improve Leg Function After SCI

Quantifying Spasticity in Activities of Daily Living

Aging

Telomeres as an Aging and Health Biomarker in Persons with Spinal Cord Injury

Muscle Weakness and Fatigue with Age after Spinal Cord Injury

Pilot Study Investigating the Impact of Time Post-Spinal Cord Injury on the Bladder Inflammatory Profile

Brain Machine Interface

Treatment of Pain and Autonomic Dysreflexia in Spinal Cord Injury with Deep Brain Stimulation (DBS)

Assessment of Candidates and Design Considerations for Neuroprosthetic Devices for Individuals with Chronic SCI

 

 
 
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