Trial Information

Summary: A Phase II Study of Autologous Incubated Macrophages for the Treatment of Complete Spinal Cord Injuries

In keeping with the goal of providing outstanding healthcare, The Mount Sinai Medical Center's Department of Rehabilitation Medicine once again takes the lead in the latest advances in spinal cord injury (SCI) research.

To date, there is no established therapeutic intervention capable of restoring significant function after SCI. Among the processes triggered by SCI is the degeneration of directly injured nerve cells and their fibers, and the subsequent (secondary) degeneration of nerve cells and fibers that escaped the initial injury but were exposed to the hostile extracellular environment created following acute injury. In contrast to other body tissues, the spinal cord and other parts of the central nervous system (CNS) have a poor ability to activate mechanisms that help to avoid the spread of damage and induce nerve fiber regeneration. As a result, spinal cord injury and the consequent nerve cell death can result in a myriad of organ/system dysfunctions below the level of the injury.

In general, following tissue injury, certain white blood cells known as activated macrophages, proceed to clean tissue debris and secrete certain chemicals and growth factors to promote wound healing. Macrophages are the janitors of the body, they clean up debris and make the place livable again. These events occur in all regenerative tissues, including the peripheral nervous system, but are severely limited in the damaged CNS.

Proneuron Biotechnologies, Inc. of Ness-Ziona, Israel has developed a product known as ProCord (macrophage therapy) that utilizes patients' own immune system for the medical treatment of spinal cord injuries. ProCord consists of macrophages isolated from the patient's own blood, activated through a specific process and injected directly into the patient's injured spinal cord. It is hoped that the introduction into the CNS of appropriate numbers of properly activated macrophages will promote a physiological healing process similar to that occurring in spontaneously regenerative tissues, thereby facilitating healing of the injured nerves.

This study is a controlled trial involving a total of 60 patients with acute complete spinal cord injuries (ASIA A), two thirds of whom will be assigned randomly to the treatment group. One third will be assigned to the control group, which will only get traditional acute medical and rehabilitative treatment. The Mount Sinai Medical Center has received approval from the Institutional Review Board (GCO#: 03-0916 approved through 11/17/2005) to begin enrolling patients in this trial.

With the collaboration of Sinai's exceptional neurosurgical team, we began subject enrollment in October of 2004. The Mount Sinai staff is always taking strides to minimize the devastating effects of SCI, by exploring new ideas and possibilities to restore function to this patient population.

Compensation Provided

Patient Inclusion/Exclusion Criteria:

Traumatic SCI, within 14 days of injury
16-65 years of age
Neurologically Complete SCI ? Defined by the American Spinal Injury Association as classification A (ASIA A)
Single spinal cord lesion from motor level C-5 to neurological T-11

The location and size of the injury cannot be determined by MRI
Women who are pregnant or breast feeding
Coma at the time of enrollment
Hgb <8.5 gm/dl
HIV(+); HBsAg(+); anti-HCV(+)
Gunshot wound or other penetrating trauma to and/or transection of the spinal cord
Fever (Temp >38.4oC, 101.1oF) in the 24 hours prior to surgery
Blood transfusion within 3 days of surgery
Ventilator assistance within 24 hours of surgery
Serious, pre-existing medical conditions
Mechanical ventilation due to neurological impairment
Disease or impairment that precludes adequate neurological exam
Rx with immune modulators or experimental drugs in 60 days prior to enrollment
Longitudinal size of lesion by MRI >3 cm

If you would like to learn more about participating in this study, please send an e-mail message using the form below.