Autologous Incubated Macrophages for Patients With Complete Spinal Cord Injuries
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ClinicalTrials.gov Identifier: NCT00073853 |
Recruitment Status :
Suspended
First Posted : December 11, 2003
Last Update Posted : August 28, 2009
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Spinal Cord Injury | Procedure: Autologous Incubated Macrophages (cell therapy) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 61 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | September 2003 |

- Improvement of ASIA grade
- Sensory scores
- Motor scores
- Bladder and bowel function

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Ages Eligible for Study: | 16 Years to 65 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00073853
United States, Colorado | |
Craig Hospital | |
Englewood, Colorado, United States, 80110 | |
United States, Georgia | |
Shepherd Center | |
Atlanta, Georgia, United States, 30309 | |
United States, New Jersey | |
UMDNJ | |
Newark, New Jersey, United States, 07103 | |
Kessler Medical Rehabilitation Research and Education Corporation | |
West Orange, New Jersey, United States, 07052 | |
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. | The Cleveland Clinic |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00073853 |
Other Study ID Numbers: |
22-P-01 |
First Posted: | December 11, 2003 Key Record Dates |
Last Update Posted: | August 28, 2009 |
Last Verified: | March 2006 |
paraplegia quadraplegia tetraplegia |
paralysis nerve regeneration Acute, Complete SCI |
Spinal Cord Injuries Wounds and Injuries Spinal Cord Diseases |
Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System |