Spinal Cord InjuryPhase 2NCT00073853
Autologous Incubated Macrophages for Patients With Complete Spinal Cord Injuries
A Phase 2 study testing Autologous Incubated Macrophages (cell therapy) in people with Spinal Cord Injury, run by Proneuron Biotechnologies at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Autologous Incubated Macrophages (cell therapy)
- Type of treatment
- Surgery or procedure
- How many people
- 61 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Sep 2003to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Shepherd Center
Atlanta, Georgia, 30309
Craig Hospital
Englewood, Colorado, 80110
Mount Sinai Spinal Cord Injury Model System
New York, New York, 10029
UMDNJ
Newark, New Jersey, 07103
Shriners Hospital for Children
Philadelphia, Pennsylvania, 19140
Kessler Medical Rehabilitation Research and Education Corporation
West Orange, New Jersey, 07052
About this study
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
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.
- Conditions
- Spinal Cord Injury
- Being tested
- Autologous Incubated Macrophages (cell therapy)
- Keywords
- paraplegia, quadraplegia, tetraplegia, paralysis, nerve regeneration, Acute, Complete SCI
- Medical subject headings
- Spinal Cord Injuries, Paraplegia, Quadriplegia, Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Incubated Macrophages (cell therapy)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of ASIA grade
Secondary outcomes (3)
Sensory scores
Motor scores
Bladder and bowel function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2003 (estimated)
- Study startSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants
Sponsor and investigators
- Lead sponsor
- Proneuron Biotechnologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Marcus Foundation, B.I.R.D. (Israel-U.S. Binational Industrial Research and Development)
- Investigators
- Daniel Lammertse, M.D., Study director, Craig HospitalNachshon Knoller, M.D., Study director, Chaim Sheba Medical CenterMarca Sipski, M.D., Study director, University of MiamiEdward Benzel, M.D., Study director, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00073853
- Sponsor's protocol ID
- 22-P-01
- Status last verified
- Mar 2006
- First submitted
- 10 Dec 2003
- Last updated
- 28 Aug 2009
- Results posted
- No
Publications
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.
PubMed 16235699Bomstein 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.
PubMed 14512160Rapalino 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.
PubMed 9662373Lammertse 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.
PubMed 22525310
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00073853
- Acronym / sponsor ID
- 22-P-01
- Conditions
- Spinal Cord Injury
- Keywords
- paraplegia, quadraplegia, tetraplegia, paralysis, nerve regeneration, Acute, Complete SCI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 61 participants
- Lead sponsor
- Proneuron BiotechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- The Marcus Foundation, B.I.R.D. (Israel-U.S. Binational Industrial Research and Development)
- Study start
- Sep 2003
- First posted
- 11 Dec 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Incubated Macrophages (cell therapy) | Procedure or surgery | – |
Primary outcome
Improvement of ASIA grade
3 secondary outcomes
Sensory scores
Motor scores
Bladder and bowel function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2009.
- Background: PubMed 16235699Knoller 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.
- Background: PubMed 14512160Bomstein 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.
- Background: PubMed 9662373Rapalino 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.
- Derived from this study: PubMed 22525310Lammertse 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Lammertse, M.D. study director
Craig Hospital
Nachshon Knoller, M.D. study director
Chaim Sheba Medical Center
Marca Sipski, M.D. study director
University of Miami
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Autologous Incubated Macrophages (cell therapy) in people with Spinal Cord Injury, run by Proneuron Biotechnologies at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 28 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of ASIA grade. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00073853, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2009.