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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...

 

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


PHASES

 
   

1

2

 

AUTOLOGOUS SCHWANN CELLS

 

 

Acute SCI

Closed to Enrollment

 

Chronic SCI

Enrolling

 

 

BIOMARKERS OF SCI

 

Acute SCI

 

Enrolling

 

 

NACTN

Acute SCI

Enrolling

 

 

RILUZOLE

Acute SCI

Completed

  Enrolling

 

THERAPEUTIC HYPOTHERMIA

 

Acute SCI

 

Enrolling

 

 

HuCNS-SC® STEM CELLS

 

Chronic SCI

 

 

  Enrolling

 

DBS

 

Chronic SCI

 

Enrolling

 

 

BMI

 

 

Chronic SCI

 

Pending

 

 

 

 

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

TOPIC

STUDY

 

Pain Survey #1

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

 

 Activity
and
Nutrient Modifying

 

Clinically Meaningful Changes in Wheelchair Propulsion Stress

Training Programs to Improve Outcomes for Individuals with Spinal Cord Injury

Cardiorespiratory Responses to Intermittent Hypoxia Exposure in Individuals With Spinal Cord Injury

Male Fertility


Fertility Evaluation

Treatment of Infertility

Rehabilitation


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

Sleep Study


Sleep Disordered Breathing in Chronic SCI: A Randomized Controlled Trial of Treatment impact on Cognition, Quality of Life, and Cardiovascular Disease

 

Brain Machine
Interface Study

 

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

 

 

 

 

Human Motor Control
and
Plasticity

 

 

 

 

Bilateral Control of Arm Movement after Spinal Cord Injury

Synchronization of Corticospinal Volleys After Spinal Cord Injury

Bilateral Force Coupling after Spinal Cord Injury

 Reorganization of Motor Cortical Representations after Spinal Cord Injury

Spike-timing Dependent Plasticity after Spinal Cord Injury

 

 
 
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