| First Published on Clinicaltrials.gov: |
3/1/2010 |
| Status: |
Ongoing, But Not Recruiting |
| ClinicalTrials.gov ID: |
NCT01082653 |
| Sponsor: |
TCA Cellular Therapy |
| Purpose: |
The primary purpose of this study is to evaluate safety of the infusion procedure, as assessed by absence of complications at the site of infusion or the appearance of new neurologic deficit not attributed to the natural progression of the disease. |
| Phase: |
I |
| Treatment Type: |
Intrathecal infusion |
| Trial Type: |
Open label |
| Estimated Enrollment: |
6 |
| Eligibility: |
18 years to 80 years. Both Genders. No healthy volunteers. |
| Details: |
One arm study: one-time intrathecal infusion of autologous bone marrow-derived stem cells suspended in infusion medium. After cell infusion patients will be followed at WK 2, MN 1, MN 2, MN 6 and a long-term followup at MN 12 in the clinic and/or office. |
| Collaborator(s): |
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| Location(s): |
- Covington, LA, 70433, United States
|
| Primary Investigator: |
Gabriel P. Lasala, MD TCA Cellular Therapy, LLC |
| Contact: |
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| Trial Protocol as Published on Clinicaltrials.gov: |
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| ALS Forum: |
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