Status:
SUSPENDED
Transfer of Bone Marrow Derived Stem Cells for the Treatment of Spinal Cord Injury
Lead Sponsor:
TCA Cellular Therapy
Conditions:
Spinal Cord Injury
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study is based on preclinical (animal) studies showing that infusing bone marrow-derived mesenchymal stem cells into the spinal fluid may contribute to improving neurologic function in animal mod...
Detailed Description
A Phase I, single-center trial to assess the safety and tolerability of an intrathecal infusion (lumbar puncture) of autologous, ex vivo expanded bone marrow-derived mesenchymal stem cells in a well-d...
Eligibility Criteria
Inclusion
- Age 18 to 65
- American Spinal Injury Association Impairment Scale A
- Clinical evidence of lesions located below c-spine 5 (C-5)
- Confirmation by MRI of injury level
- Time between injury and enrollment greater than 2 weeks
- Ability to provide informed consent
- Platelet count greater than 100 Thousand/uL at screening
- INR equal to or less than 1.5
- Hematocrit less than 30% prior to bone marrow aspiration
- Spinal cord injury within 60 months of screening
Exclusion
- Anoxic brain injury
- Inability to provide consent
- Sepsis
- Neurological deficits attributed to lesions above C-5
- Cerebro-vascular accidents with intracranial hemorrhage, acute brain injuries, meningitis, hydrocephalus or other potential diseases where the pressure in the cerebro spinal fluid is increased
- Multiple sclerosis
- Amyotrophic lateral sclerosis
- Cerebral Palsy
- Evidence of cancer over the last 3 years prior to enrollment
- Immunosuppressive diseases
- Platelet count lower than 100,000
- White blood count greater than 15,000 unless the patient is on steroids
- Bleeding disorders
- Clinical or laboratory evidence of meningitis
- Skin infection at the infusion site
- Pregnant or planning to become pregnant
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2014
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01162915
Start Date
July 1 2010
End Date
May 1 2014
Last Update
May 9 2014
Active Locations (1)
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1
TCA Cellular Therapy, LLC
Covington, Louisiana, United States, 70433