Autologous Incubated Macrophages for Patients With Complete Spinal Cord Injuries
NCT ID: NCT00073853
Last Updated: 2009-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE2
61 participants
INTERVENTIONAL
2003-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Autologous Incubated Macrophages (cell therapy)
Eligibility Criteria
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Inclusion Criteria
* Age 16 to 65 years
* Complete spinal cord injury (ASIA A)
* Neurological level : C5 to T11
* MRI showing lesion
Exclusion Criteria
* Coma or other severe injury or disease
* Penetrating injury
* Ongoing mechanical ventilation
* Unsuitable based on MRI or other factor
16 Years
65 Years
ALL
No
Sponsors
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The Marcus Foundation
OTHER
B.I.R.D. (Israel-U.S. Binational Industrial Research and Development)
UNKNOWN
Proneuron Biotechnologies
INDUSTRY
Principal Investigators
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Daniel Lammertse, M.D.
Role: STUDY_DIRECTOR
Craig Hospital
Nachshon Knoller, M.D.
Role: STUDY_DIRECTOR
Chaim Sheba Medical Center
Marca Sipski, M.D.
Role: STUDY_DIRECTOR
University of Miami
Edward Benzel, M.D.
Role: STUDY_DIRECTOR
The Cleveland Clinic
Locations
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Craig Hospital
Englewood, Colorado, United States
Shepherd Center
Atlanta, Georgia, United States
UMDNJ
Newark, New Jersey, United States
Kessler Medical Rehabilitation Research and Education Corporation
West Orange, New Jersey, United States
Mount Sinai Spinal Cord Injury Model System
New York, New York, United States
Shriners Hospital for Children
Philadelphia, Pennsylvania, United States
Chaim Sheba Medical Center
Tel Litwinsky, , Israel
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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22-P-01
Identifier Type: -
Identifier Source: org_study_id