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Based on a business decision unrelated to any safety concerns.
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This study will evaluate the safety and efficacy of human central nervous system stem cell transplantation into patients with traumatic injury in the cervical region of the spinal cord.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HuCNS-SC cells | Experimental | Intramedullary transplantation of HuCNS-SC cells in the cervical spine |
|
| non-surgery arm | No Intervention | non-surgery arm |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HuCNS-SC cells | Drug | surgery arm |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in ISNCSCI upper extremity motor scores | Up to one year after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with serious and non-serious adverse events | Safety measures will include collection of adverse events, laboratory tests, neurological examination, ISNCSCI motor and sensory scores, pain and allodynia assessment, AIS grade, physical examination and modified Ashworth scale | Up to one year from the time of enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Huhn, MD | StemCells, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rancho Los Amigos National Rehabilitation Center/USC | Downey | California | 90242 | United States | ||
| University of Miami Miller School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27130222 | Derived | Ahuja CS, Fehlings M. Concise Review: Bridging the Gap: Novel Neuroregenerative and Neuroprotective Strategies in Spinal Cord Injury. Stem Cells Transl Med. 2016 Jul;5(7):914-24. doi: 10.5966/sctm.2015-0381. Epub 2016 Apr 29. |
| Label | URL |
|---|---|
| Study Website | View source |
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| Miami |
| Florida |
| 33136 |
| United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Maryland Medical Systems | Baltimore | Maryland | 21201 | United States |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
| University of Minnesota/Courage Kenny Rehabilitation Institute | Minneapolis | Minnesota | 55414 | United States |
| Mount Sinai Medical Center, Dept of Neurosurgery | New York | New York | 10029 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Texas, Mischer Neuroscience Institute | Houston | Texas | 77030 | United States |
| University of Utah Health Sciences Center | Salt Lake City | Utah | 84132 | United States |
| Medical College of Wisconsin/Froedtert Hospital | Milwaukee | Wisconsin | 53226 | United States |
| Foothills Medical Center | Calgary | Alberta | T2N 2T9 | Canada |
| Toronto Western Hospital | Toronto | Ontario | M9R1L5 | Canada |
| ID | Term |
|---|---|
| D013124 | Spinal Injuries |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D019567 | Back Injuries |
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