Safety Study of Human Spinal Cord-derived Neural Stem Cell Transplantation for the Treatment of Chronic SCI (SCI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01772810|
Recruitment Status : Recruiting
First Posted : January 21, 2013
Last Update Posted : September 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury (SCI)||Drug: Human spinal cord stem cells.||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Open-label, Single-site, Safety Study of Human Spinal Cord-derived Neural Stem Cell Transplantation for the Treatment of Chronic SCI|
|Actual Study Start Date :||August 2014|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||December 2022|
Experimental: Surgical implantation of human spinal cord stem cells
Surgical implantation of human spinal cord derived neural stem cells.
Drug: Human spinal cord stem cells.
Human spinal cord stem cell implantation in paralysis patients due to a spinal cord injury.
Other Name: spinal cord injury (SCI)
- Adverse events and clinically significant laboratory abnormalities [ Time Frame: 6 months ]
- Graft survival in the transplant site as determined by MRI (for Group A) and via autopsy, if one is completed. [ Time Frame: Month 60 ]Effectiveness of immunosuppression as determined by absence of donor-specific HLA antibodies.
- EMG, SCIM, ISNC SCI, and Bowel and bladder follow-up [ Time Frame: 60 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01772810
|Contact: Dr. Ciacci's Research Group||844-317-7836 (STEM)||firstname.lastname@example.org|
|United States, California|
|UCSD Medical Center, Division of Neurosurgery||Recruiting|
|San Diego, California, United States, 92103-8893|
|Contact: Dr. Ciacci's Research Group 844-317-7836 email@example.com|
|Principal Investigator: Joseph Ciacci, MD|
|Sub-Investigator: Martin Marsala, MD|
|Principal Investigator:||Joseph Ciacci, MD||UCSD Medical Center, Division of Neurosurgery|