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| Name | Class |
|---|---|
| The Marcus Foundation | OTHER |
| B.I.R.D. (Israel-U.S. Binational Industrial Research and Development) | UNKNOWN |
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Incubated Macrophages (cell therapy) | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of ASIA grade |
| Measure | Description | Time Frame |
|---|---|---|
| Sensory scores | ||
| Motor scores | ||
| Bladder and bowel function |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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. | The Cleveland Clinic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Craig Hospital | Englewood | Colorado | 80110 | United States | ||
| Shepherd Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16235699 | Background | Knoller N, Auerbach G, Fulga V, Zelig G, Attias J, Bakimer R, Marder JB, Yoles E, Belkin M, Schwartz M, Hadani M. Clinical experience using incubated autologous macrophages as a treatment for complete spinal cord injury: phase I study results. J Neurosurg Spine. 2005 Sep;3(3):173-81. doi: 10.3171/spi.2005.3.3.0173. | |
| 14512160 | Background |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D010264 | Paraplegia |
| D011782 | Quadriplegia |
| D010243 | Paralysis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D064987 | Cell- and Tissue-Based Therapy |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| Atlanta |
| Georgia |
| 30309 |
| United States |
| UMDNJ | Newark | New Jersey | 07103 | United States |
| Kessler Medical Rehabilitation Research and Education Corporation | West Orange | New Jersey | 07052 | United States |
| Mount Sinai Spinal Cord Injury Model System | New York | New York | 10029 | United States |
| Shriners Hospital for Children | Philadelphia | Pennsylvania | 19140 | United States |
| Chaim Sheba Medical Center | Tel Litwinsky | 52621 | Israel |
| Bomstein Y, Marder JB, Vitner K, Smirnov I, Lisaey G, Butovsky O, Fulga V, Yoles E. Features of skin-coincubated macrophages that promote recovery from spinal cord injury. J Neuroimmunol. 2003 Sep;142(1-2):10-6. doi: 10.1016/s0165-5728(03)00260-1. |
| 9662373 | Background | Rapalino O, Lazarov-Spiegler O, Agranov E, Velan GJ, Yoles E, Fraidakis M, Solomon A, Gepstein R, Katz A, Belkin M, Hadani M, Schwartz M. Implantation of stimulated homologous macrophages results in partial recovery of paraplegic rats. Nat Med. 1998 Jul;4(7):814-21. doi: 10.1038/nm0798-814. |
| 22525310 | Derived | Lammertse DP, Jones LA, Charlifue SB, Kirshblum SC, Apple DF, Ragnarsson KT, Falci SP, Heary RF, Choudhri TF, Jenkins AL, Betz RR, Poonian D, Cuthbert JP, Jha A, Snyder DA, Knoller N. Autologous incubated macrophage therapy in acute, complete spinal cord injury: results of the phase 2 randomized controlled multicenter trial. Spinal Cord. 2012 Sep;50(9):661-71. doi: 10.1038/sc.2012.39. Epub 2012 Apr 24. |
| D014947 | Wounds and Injuries |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |