Autologous Incubated Macrophages for Patients With Complete Spinal Cord Injuries

Proneuron Biotechnologies

Status and phase: Suspended; Phase 2

Conditions: Spinal Cord Injury

Treatments: Procedure: Autologous Incubated Macrophages (cell therapy)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00073853

22-P-01

Details and patient eligibility

About

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.

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)