Clinical trial NCT00073853: Autologous Incubated Macrophages for Patients With Complete Spinal Cord Injuries
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 type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Spinal Cord Injury
Keywords: paraplegia
quadraplegia
tetraplegia
paralysis
nerve regeneration
Acute, Complete SCI
Lead sponsor: Proneuron Biotechnologies
Sponsor class: INDUSTRY
Collaborators: name: The Marcus Foundation
name: B.I.R.D. (Israel-U.S. Binational Industrial Research and Development)
First posted: 2003-12-11
Enrollment: 61
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Improvement of ASIA grade
Secondary outcomes:
measure: Sensory scores
measure: Motor scores
measure: Bladder and bowel function
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Craig Hospital
state: Colorado
city: Atlanta
country: United States
facility: Shepherd Center
state: Georgia
city: Newark
country: United States
facility: UMDNJ
state: New Jersey
city: West Orange
country: United States
facility: Kessler Medical Rehabilitation Research and Education Corporation
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Spinal Cord Injury Model System
state: New York
city: Philadelphia
country: United States
facility: Shriners Hospital for Children
state: Pennsylvania
city: Tel Hashomer
country: Israel
facility: Chaim Sheba Medical Center
Study officials:
affiliation: Craig Hospital
name: Daniel Lammertse, M.D.
role: STUDY_DIRECTOR
affiliation: Chaim Sheba Medical Center
name: Nachshon Knoller, M.D.
role: STUDY_DIRECTOR
affiliation: University of Miami
name: Marca Sipski, M.D.
role: STUDY_DIRECTOR
affiliation: The Cleveland Clinic
name: Edward Benzel, M.D.
role: STUDY_DIRECTOR
References:
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. doi: 10.3171/spi.2005.3.3.0173.
citation: 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.
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. doi: 10.1038/nm0798-814.
citation: 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.