- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01162915
Transfer of Bone Marrow Derived Stem Cells for the Treatment of Spinal Cord Injury
Phase I, Single Center, Trial to Asses Safety and Tolerability of the Intrathecal Infusion of Ex-vivo Expanded Bone-marrow Derived Mesenchymal Stem Cells for the Treatment of Spinal Cord Injury
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 models with spinal cord injuries. Bone marrow (BM) contains several types of stem cells that can produce functional cells. This includes cells that could help the healing process of damaged neurologic tissue.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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-defined population of spinal cord injury patients.
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Louisiana
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Covington, Louisiana, United States, 70433
- TCA Cellular Therapy, LLC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Safety
Infusion of autologous bone marrow-derived mesenchymal stem cells.
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Intrathecal infusion of a single dose of ex vivo expanded MSC.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety
Time Frame: 12 months
|
Phase I trial to assess safety of intrathecal infusion of autologous mesenchymal stem cell treatment in spinal cord injury.
|
12 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009-SCI-I
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Spinal Cord Injury
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-
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Kevin KilgoreNational Institute of Neurological Disorders and Stroke (NINDS); Case Western... and other collaboratorsRecruitingSpinal Cord Injuries | Spinal Cord Injury at C5-C7 Level | Spinal Cord Injury Cervical | Spinal Cord Injury at C5-C7 Level With Complete Lesion | Spinal Cord Injury at C5-C7 Level With Incomplete LesionUnited States
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-
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-
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Kessler FoundationNew Jersey Commission on Spinal Cord ResearchRecruitingSpinal Cord Injuries | Incomplete Spinal Cord InjuryUnited States
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