Sponsor/Curative Therapy

 Clinical Phase & ID

 What's Going On?

BioAxone Cethrin BA-210 in Complete "Acute" Cervical C5-C6-C7 & Thoracic SCIs. News: & Results:

 

Phase I/II Completed
NCT00500812
NCT00610337

Recruited at 8 locations in the US and Canada.  Motor recovery trial suggests BA-210 may increase neuro recovery.  Further clinical trials planned, Michael J. Fehlings, MD, PhD-PI, Canada. Responsible Party: Talaris Advisors  BioAxone BioSciences intends to move forward with a placebo-controlled Cethrin Phase 2b trial, and plans to begin enrollment in 2012 for Acute Injury. Now located in Ft. Lauderdale, FL.

Cairo University Autologous Bone Marrow Transplant for Chronic SCIs with a duration of injury from 10 months to 3 years.

Phase II Completed
NCT00816803

Recruited at Cairo University School of Medicine, Cairo, Egypt. 

International Stemcell Services Ltd Trans. Autologous BMSC with Glial Scar Resection, Chronics, Acute, Subacute. 

Phase I/II Completed
NCT01186679

Recruited at Sita Bhateja Speciality Hospital Bangalore, Karnataka, India, Dr. Arvind Bhateja, MCh-PI 

Stem Cells, Inc.  HuCNS-SC in Thoracic T2-T11 SCIs, greater than 6 weeks post injury and evidence of conus function. (Video) 

Phase I/II
NCT01321333

Recruiting at Balgrist University, Zurich, Switzerland, Armin Curt, MD-PI  Asia A enrollment completed.  Asia B & C patient enrollment is open to USA and Canada.   (StemCells Inc. Video Library)

 Phase I/II

NCT01490242

China SCI Network  Umbilical Cord Blood Mononuclear Cell and Lithium in Acute & Sub-Acute SCI  (Video)

Phase I/II
NCT00517374 NCT00592722
NCT00750061 NCT01046786 
NCT01393977 

NCT01471613

Multi center in China   CN100 Observational Trial Completed - CN101&CN102A Lithium Ph I/II Completed - CN102B UCBNCs & Lithium Ph II Recruiting - CN103 UCBMNCs & Lithium (might add Methylprednisolone to PhII) Ph III Plan to begin in 2012. Wise Young MD,PhD-Director
Chinese Armed Forces Phase 11 Rehab vs. UCBMNCs 

Montreal General Hospital  Spinalon: An oral tritherapy to acutely trigger short episodes of walking on complete chronic 3 months post SCI Asia A&B. Thoracic and Cervical C3-C8
News Release: 

 Phase I/IIa
 NCT01484184

Pre-IND granted by FDA Jan. 2010. Recruiting Late 2011 McGill University Health Ctr, Funded by the US Dept. of Defense and US Army. Start Date: May 2012 Study Director Pierre Guertin, PhD Report:   Related Links: NIH -Center for Translative Meds.

Proneuron Biotechnologies-ProCord  Autologous Incubated Macrophages in Complete, Acute C5-T11 SCIs.

Phase II Suspended
NCT00073853

PhI in Belgium and Israel, 50 enrolled between 2003 & 2006.  Trial suspended for financial reasons. Study Directors: D. Lammertse, MD, Nachshon Knoller, MD, Marca Sipski, MD, Edward Benzel, MD 

Taipei Veterans General  Hospital Applying Acidic fibroblast growth factor (aFGF; also known as FGF-1) and peripheral nerve bridging. Fibrin glue.

Phase I/II 
VGHTPE.GOV.TW

Dr. Henreich Cheng Hung-chih Principal Investigator, Taipei Veterans General Hospital applying for Phase 3
News Release: &  Video:  Lab Report:

Translational Research Informatics Ctr.  Bone Marrow Stromal Cell Transplant in Acute SCIs.

Phase II Completed
NCT00695149

Recruited at Kansai Medical University Moriguchi, Osaka, Japan 

California Stem Cell, Inc.  Motorgraft Safety Study Stem Cell-derived Motor Neuron Transplantation for SMA-Type 1  Video#1 & Video#2  Info Link

Phase I
On Hold 

Hans Keirstead Research Group, University of California-Irvine. Orphan Drug status granted in 2009. Feb 7, 2011 - FDA requested additional animal study and completion of ongoing SMA animal studies. Completed FDA GLP safety for Motor Neurons. Hans Keirstead Principal Investigator. Applications for ALS and SCI are in pre-clinical development. (News Link) 

Geron Corporation  Injection of hESC-derived GRNOPC1 in Complete, T3-T11 SCIs, 7-14 days post injury.

Phase I
NCT01217008
Discontinued

Recruiting at 7 locations in the US. Santa Clara Valley Med Ctr, CA. G. Steinberg MD PhD-PI, Shepherd Center, Atlanta, GA - D. Apple MD-PI, Northwestern Univ. Med Ctr, Chicago, IL-R. Fessler MD,PhD-PI, The Jefferson Univ. Hospital, Philadelphia PA - J. Harrop MD-PI, The Medical College of WI, Milwaukee, WI - Shekar Kurpad MD-PI, U of MD Rehab Institute at Kernan Hosp, Baltimore, MD - Peter Gorman MD-PI. Staggered patient enrollment of 10 days.  

Hospital Sao Rafael  Autologous Bone Marrow Cell Transplantation in Complete Thoracic & Lumbar SCIs 

Phase I
NCT01325103

Active, but not recruiting at Hospital Sao Rafael, Salvador, Bahia, Brazil. Ricardo R. Santos, MD, PhD - PI  (Video)

Phase I Approved

Methodist Hospital System Pharmacokinetics of Riluzole in Acute  C4-T12 SCIs

Phase I Completed
NCT00876889

Ph I included 36 subjects. Recruited at 6 hospitals in USA and 1 in Canada.  Drug approved for ALS under brand name Rilutek.  SCI preclinical studies showed neurotrophic effect.  Numerous ongoing clinical trials for various diseases and conditions with this drug. 

Memorial Hermann Healthcare System Autologous Stem Cells for Chronic SCIs in Children Ages 1-15 years old 

Phase I NCT01328869

Recruiting at Memorial Hermann Hospital, Houston, Texas  James E. Baumgartner, MD – PI

Novartis  Pharmacokinetics of Intrathecal Administered AT 1355 Anti-Nogo in Complete C5 to T12 Acute SCIs  

Phase I Completed
NCT00406016 

Recruiting at multi center sites in the US, Canada, Germany, Spain, Switzerland.  Robert Grossman, MD-PI  Planned Filing 2015 

Spinal Cord Society of New Zealand  Transplant Olfactory Ensheathing Cells (OECs) and Scar Removal and Rehabilitation.

Phase I Approved
Information:

Recruiting: Trial to begin Early 2012 For 12 People with Complete Thoracic SCI, Ages 18-35 With Injury (2-7 years post) News Release:                      
Jim Faed, MD - Clinical Research Director 

TCA Cellular Therapy LLC  Intrathecal Infusion BMSC in Complete, below C5, Subacute & Chronic SCIs  (Video)

Phase I
NCT01162915

Not Recruiting, but Ongoing: TCA, Covington, LA.  Gabriel P. Lasala, MD-PI (On hold by the FDA) 

The Miami Project  Therapeutic Hypothermia (ARTIC) in Acute Cervical SCIs 

Phase I
Completed

NIH Neurologic Emergency Treatment Trials revised proposal to be submitted. Multi center Hypothermia Trial (ARTIC) Ph II study, 17 centers, 210 patients randomized for normothermic vs hypothermic treatment. 

Wroclow Medical University  Autologous Olfactory Ensheathing Cells in Complete C5 to L5, Subacute and Chronic SCIs 

Phase I 
NCT01231893

Recruiting at Department of Neurosurgery at Wroclow Medical University, Wroclow, Poland.  Pawel Tabakow, MD, PhD - PI
Study Information:

InVivo Therapeutics  Biocompatible Polymer Scaffolding in Acute SCIs (Video#1)  & (Video#2)

IDE Application 

Investigational Device Exemption (IDE) application currently being reviewed by FDA. Partnership with the Miami Project 

Neuralstem, Inc.  Human Clinical Trial with Stem Cells in Chronic SCIs (Video#1) & (Video#2)

IND Application 

Investigational New Drug (IND) application currently under review by FDA. Currently conducting ALS clinical trial. Jonathan Glass, MD-PI News Release #1:   News Release #2: 

The Miami Project  Human Schwann Cell Transplantation in Acute, Severe SCIs(Video) begins @ 5:30 min.

Preparing IND

This Phase I trial will be a dose escalation safety in 9-12 patients.  Partnership with InVivo Therapeutics 

APINME Assoc.  Bone Marrow Stromal Cells in Complete Thoracic, Chronic SCIs 

Pending Trial 

Recruiting at Hospital University, Puerta de Hierro, Madrid, Spain.  Dr. Vaquero-PI Projected Start April 2012 

 Guangzhou General Hosp. Intravenous combined with intrathecal administration of autologous bone marrow derived mesenchymal stem cells 

 Phase 1 & II

NCT01446640