Suspended

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

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What is being tested

Data Collection

Who is being recruted

Central Nervous System Diseases+3

+ Nervous System Diseases

+ Spinal Cord Diseases

From 16 to 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 2003
See protocol details

Summary

Principal SponsorProneuron Biotechnologies
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2003

Actual date on which the first participant was enrolled.

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.

Official TitleA 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 
Principal SponsorProneuron Biotechnologies
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

61 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 16 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Central Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesSpinal Cord InjuriesWounds and InjuriesTrauma, Nervous System

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Suspended

Craig Hospital

Englewood, United StatesSee the location
Suspended

Shepherd Center

Atlanta, United States
Suspended

UMDNJ

Newark, United States
Suspended

Kessler Medical Rehabilitation Research and Education Corporation

West Orange, United States
Suspended7 Study Centers