Autologous Incubated Macrophages for Patients With Complete Spinal Cord Injuries

Spinal Cord Injury Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00073853
• Other study ID #: 22-P-01
• Status: Suspended
• Phase: Phase 2
• First received: December 10, 2003
• Last updated: August 27, 2009
• Start date: September 2003

Study information

• Verified date: March 2006
• Source: Proneuron Biotechnologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 61
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Procedure:
• Autologous Incubated Macrophages (cell therapy)

Locations

Country	Name	City	State
Israel	Chaim Sheba Medical Center	Tel Hashomer
United States	Shepherd Center	Atlanta	Georgia
United States	Craig Hospital	Englewood	Colorado
United States	Mount Sinai Spinal Cord Injury Model System	New York	New York
United States	UMDNJ	Newark	New Jersey
United States	Shriners Hospital for Children	Philadelphia	Pennsylvania
United States	Kessler Medical Rehabilitation Research and Education Corporation	West Orange	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Proneuron Biotechnologies	B.I.R.D. (Israel-U.S. Binational Industrial Research and Development), The Marcus Foundation

Countries where clinical trial is conducted

United States,  Israel, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of ASIA grade
Secondary	Sensory scores
Secondary	Motor scores
Secondary	Bladder and bowel function