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Home > "A" Clinical Trials Conditions > Autologous Incubated Macrophages for the Treatment of Patients with Complete Spinal Cord Injuries  Autologous Incubated Macrophages for the Treatment of Patients with Complete Spinal Cord Injuries
Autologous Incubated Macrophages for the Treatment of Patients with Complete Spinal Cord Injuries
For Condition: Spinal Cord Injury
Status: Recruiting
Sponsor(s): Proneuron Biotechnologies ,
Synopsis: Autologous Incubated Macrophage Therapy (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 âimmune privilege.â Autologous Incubated Macrophage therapy is designed to circumvent the immune privilege, thus supporting the regrowth of axons through the injury site and enabling the recovery of neurological function. The therapy derives from the pioneering research of Prof. Michal Schwartz at the Weizmann Institute of Science.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 16 Years/65 Years
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 61
Location and Contact Information:
Chaim Sheba Medical Center *Recruiting*
Tel Hashomer, , 52621
Israel
Recruiting Nachshon Knoller
Kessler Medical Rehabilitation Research and Education Corporation *Not yet recruiting*
West Orange, New Jersey, 07052
United States
Not yet recruiting Steven Kirshblum
Mount Sinai Spinal Cord Injury Model System *Not yet recruiting*
New York City, New York, 10029
United States
Not yet recruiting Kristjan Ragnarsson
Craig Hospital *Recruiting*
Englewood, Colorado, 80110
United States
Recruiting Daniel Lammertse
Additional Information:
Study ID Numbers: 22-P-01;
Study Start Date: December 2003
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00073853
Other Spinal Cord Injury Studies:
1. Methylprednisolone Given by 24-Hour or 48-Hour Infusion versus Tirilazad for Acute Spinal Cord Injury
2. Effects of Acute SCI on Colonic Motility & Tone
3. Mechanisms of Human Plasticity in the Human System
4. Magnetic Resonance Imaging Studies of Motor and Thought Processes
5. Autologous Incubated Macrophages for the Treatment of Patients with Complete Spinal Cord Injuries
Related Studies:
Other Spinal Cord Injury Clinical Trials
Other New Jersey Clinical Trials
Other West Orange Clinical Trials
Autologous Incubated Macrophages for the Treatment of Patients with Complete Spinal Cord Injuries
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