- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00073853
Autologous Incubated Macrophages for Patients With Complete Spinal Cord Injuries
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Tel Hashomer, Israel, 52621
- Chaim Sheba Medical Center
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Colorado
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Englewood, Colorado, United States, 80110
- Craig Hospital
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Georgia
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Atlanta, Georgia, United States, 30309
- Shepherd Center
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New Jersey
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Newark, New Jersey, United States, 07103
- UMDNJ
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West Orange, New Jersey, United States, 07052
- Kessler Medical Rehabilitation Research and Education Corporation
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New York
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New York, New York, United States, 10029
- Mount Sinai Spinal Cord Injury Model System
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19140
- Shriners Hospital for Children
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Traumatic SCI during last 14 days
- Age 16 to 65 years
- Complete spinal cord injury (ASIA A)
- Neurological level : C5 to T11
- MRI showing lesion
Exclusion Criteria:
- Women who are pregnant or breastfeeding
- Coma or other severe injury or disease
- Penetrating injury
- Ongoing mechanical ventilation
- Unsuitable based on MRI or other factor
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Improvement of ASIA grade
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Secondary Outcome Measures
Outcome Measure |
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Sensory scores
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Motor scores
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Bladder and bowel function
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- 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., The Cleveland Clinic
Publications and helpful links
General Publications
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-P-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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