好色先生

好色先生

Explore the latest content from across our publications

Log In

Forgot Password?
Create New Account

Loading... please wait

Abstract Details

A Phase 1/2a Open-Label Study to Investigate the Safety of the Transplantation (by Injection) of Human Glial Restricted Progenitor Cells (hGRPs; Q-Cells®) into Subjects with Transverse Myelitis (TM)
Autoimmune Neurology
P1 - Poster Session 1 (5:30 PM-6:30 PM)
15-020
  • The primary objective of the study is to evaluate the safety of Q-Cells® transplantation into the posterior columns of the spinal cord in patients with Transverse Myelitis

  •  

A secondary objective of the study is to obtain preliminary data regarding the clinical activity of Q-Cells®

Transverse Myelitis (TM) is an inflammatory condition of the spinal cord that leads to demyelination. Use of a cellular therapeutic to supply oligoprogenitor cells to induce remyelination is proven in animal models.


Enrollment is planned for up to 9 subjects over 12 months. 3 subjects in each co hort. Each subject receives a single time point administration of Q-Cells®: with 10 unilateral injections targeted to posterior columns of the spinal cord.  An observational period of each subject will be completed, before moving forward with next subject, and the next co hort.

 

Study data will be assessed for safety and activity after the last subject has completed the 9-month study visit.  Following the 9-month study period, subjects who consent will continue to be followed for safety and activity long-term in a separate protocol.

 

Involvement consists of Screening, Pre-operative/Treatment, and Post-treatment study periods.  Post treatment will be conducted at Study site only. 

 

Subjects must have the ability to undergo a laminectomy, and extensive immunosuppressive therapy for a prescribed period.  Subjects must be ASIA 2 (paralyzed), be able to complete MRI’s, and complete multiple follow-up visits.


Remyelination has been proven in animal models.  No results from human trials, as yet.
No conclusions have been reached in human trials, as yet.
Authors/Disclosures
Jan Cameron Watts, RN (University of Texas Southwestern Medical Center)
PRESENTER
No disclosure on file
Benjamin M. Greenberg, MD, FAAN (UT Southwestern Medical Center) Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Greenberg has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. Dr. Greenberg has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amgen. Dr. Greenberg has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Sanofi/Genzyme. Dr. Greenberg has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech/Roche. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Signant. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for IQVIA. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sandoz. Dr. Greenberg has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Clene. Dr. Greenberg has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for TG Therapeutics. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for IQVIA. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abcuro. Dr. Greenberg has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Siegel Rare Neuroimmune Association. Dr. Greenberg has or had stock in GenrAb.Dr. Greenberg has or had stock in Clene.Dr. Greenberg has received intellectual property interests from a discovery or technology relating to health care. Dr. Greenberg has received publishing royalties from a publication relating to health care.