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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01162915 |
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Date of registration:
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13/07/2010 |
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Primary sponsor: |
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Public title:
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Transfer of Bone Marrow Derived Stem Cells for the Treatment of Spinal Cord Injury
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Scientific title:
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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 |
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Date of first enrolment:
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July 2010 |
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Target sample size:
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10 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01162915 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Gabriel P Lasala, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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TCA Cellular Therapy, LLC |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Spinal Cord Injury
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Intervention(s)
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Biological: autologous mesenchymal stem cells
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Primary Outcome(s)
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Safety
[Time Frame: 12 months]
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Secondary ID(s)
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2009-SCI-I
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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