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| Sponsor: | Proneuron Biotechnologies |
|---|---|
| Collaborators: |
Marcus Foundation B.I.R.D. (Israel-U.S. Binational Industrial Research and Development) |
| Information provided by: | Proneuron Biotechnologies |
| ClinicalTrials.gov Identifier: | NCT00073853 |
Purpose
Autologous Incubated Macrophages (ProCord) is being developed as a therapy for acute, complete spinal cord injury (SCI). The therapy is intended to reverse the loss of motor and sensory function.
Following non-CNS tissue injury, macrophages quickly arrive on the scene, where they clean up cell debris, secrete different molecules thus promoting a controlled inflammatory reaction that forms the first phase of the wound healing process. While this process occurs in most tissues, including peripheral nerves, it does not occur in the CNS, where macrophages and other immune cells are relatively rare, and their activities curtailed by a biochemical mechanism known as "immune privilege."
In animal studies, it appears that incubated macrophages circumvent the immune privilege, thus supporting the regrowth of axons through the injury site and enabling the recovery of neurological function. The concept derives from the pioneering research of Prof. Michal Schwartz at the Weizmann Institute of Science.
| Condition | Intervention | Phase |
|---|---|---|
|
Spinal Cord Injury |
Procedure: Autologous Incubated Macrophages (cell therapy) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II Multicenter, Randomized-Controlled Study to Evaluate the Safety and Efficacy of Autologous Incubated Macrophages for the Treatment of Patients With Complete Spinal Cord Injuries |
Eligibility| Ages Eligible for Study: | 16 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Colorado | |
| Craig Hospital | |
| Englewood, Colorado, United States, 80110 | |
| United States, Georgia | |
| Shepherd Center | |
| Atlanta, Georgia, United States, 30309 | |
| United States, New Jersey | |
| Kessler Medical Rehabilitation Research and Education Corporation | |
| West Orange, New Jersey, United States, 07052 | |
| UMDNJ | |
| Newark, New Jersey, United States, 07103 | |
| United States, New York | |
| Mount Sinai Spinal Cord Injury Model System | |
| New York, New York, United States, 10029 | |
| United States, Pennsylvania | |
| Shriners Hospital for Children | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Israel | |
| Chaim Sheba Medical Center | |
| Tel Hashomer, Israel, 52621 | |
| Study Director: | Daniel Lammertse, M.D. | Craig Hospital |
| Study Director: | Nachshon Knoller, M.D. | Chaim Sheba Medical Center |
| Study Director: | Marca Sipski, M.D. | University of Miami |
| Study Director: | Edward Benzel, M.D. | Cleveland Clinic |
More Information
| Study ID Numbers: | 22-P-01 |
| Study First Received: | December 10, 2003 |
| Last Updated: | August 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00073853 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
paraplegia quadraplegia tetraplegia |
paralysis nerve regeneration Acute, Complete SCI |
|
Spinal Cord Injuries Spinal Cord Diseases Nervous System Diseases Wounds and Injuries |
Disorders of Environmental Origin Central Nervous System Diseases Trauma, Nervous System |