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 macrophagescircumvent 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	Treatment or Intervention	Phase
Spinal Cord Injury	Procedure: Autologous Incubated Macrophages (cell therapy)	Phase II

Ages Eligible for Study:  16 Years   -   65 Years,  Genders Eligible for Study:  Both

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

Proneuron Patient Recruitment      1-866-539-0767    clinical.trial@proneuron.com
Proneuron Patient Recruitment      1-506-652-3486    proneuron@clinicallinc.com

Colorado
      Craig Hospital, Englewood,  Colorado,  80110,  United States; Recruiting
New Jersey
      Kessler Medical Rehabilitation Research and Education Corporation, West Orange,  New Jersey,  07052,  United States; Not yet recruiting
New York
      Mount Sinai Spinal Cord Injury Model System, New York,  New York,  10029,  United States; Not yet recruiting
Israel
      Chaim Sheba Medical Center, Tel Hashomer,  52621,  Israel; Recruiting

Study ID Numbers:  22-P-01
Record last reviewed:  December 2003
Record first received:  December 10, 2003
ClinicalTrials.gov Identifier:  NCT00073853
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-09