Transfer of Bone Marrow Derived Stem Cells for the Treatment of Spinal Cord Injury
NCT ID: NCT01162915
Last Updated: 2014-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE1
10 participants
INTERVENTIONAL
2010-07-31
2014-05-31
Brief Summary
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The primary objective of this study is to see if the injection of these cells, obtained from your own bone marrow, is safe. A secondary objective is to evaluate if the treatment can provide functional improvements (neuromuscular control and sensation) in the affected areas.
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Detailed Description
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Safety will be evaluated by neurological and non-neurological tests performed after short-term (1 to 30 days) and long-term (2 to 12 months)follow-up evaluation periods after cell infusion.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Safety
Infusion of autologous bone marrow-derived mesenchymal stem cells.
Autologous bone marrow-derived mesenchymal stem cells.
Intrathecal infusion of a single dose of ex vivo expanded MSC.
Interventions
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Autologous bone marrow-derived mesenchymal stem cells.
Intrathecal infusion of a single dose of ex vivo expanded MSC.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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TCA Cellular Therapy
INDUSTRY
Responsible Party
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Locations
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TCA Cellular Therapy, LLC
Covington, Louisiana, United States
Countries
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Related Links
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Related Info
Other Identifiers
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2009-SCI-I
Identifier Type: -
Identifier Source: org_study_id
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