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Autologous Incubated Macrophages for Patients With Complete Spinal Cord Injuries

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

Status
Suspended
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00073853
Enrollment
61
Registered
2003-12-11
Start date
2003-09-30
Completion date
Unknown
Last updated
2009-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury

Keywords

paraplegia, quadraplegia, tetraplegia, paralysis, nerve regeneration, Acute, Complete SCI

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.

Interventions

PROCEDUREAutologous Incubated Macrophages (cell therapy)

Sponsors

The Marcus Foundation
CollaboratorOTHER
B.I.R.D. (Israel-U.S. Binational Industrial Research and Development)
CollaboratorUNKNOWN
Proneuron Biotechnologies
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Improvement of ASIA grade

Secondary

MeasureTime frame
Sensory scores
Motor scores
Bladder and bowel function

Countries

Israel, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026