2018 World Premiere: a life-changing therapy for SCI patients

Subscription

Different steps of the clinical trial project

ClINICAL TRIAL PROCEDURE FOR THE PATIENT  

 
The final objective of Neurogelen Marche  Association wants to set up  a clinical trial in France, combining NEUROGEL™  with  EPO & progesterone,  the added efficacy of the two hormones having been demonstrated in animal trials.
 
The Association’s scientific council would like to conduct this first trial in 15 patients.

Additionally, Dr. Pawan Kumar GUPTA is also seeking funding for a 5 patient clinical trial in India.   His approach is slightly different since he wants to combine NEUROGEL™  with stem cells.

For the volunteer patients selected by the scientists, the clinical trial will include two major stages.

The operation :

The operation involves a graft of  NEUROGEL™ to replace the glial scar.
 
Rehabilitation :

To allow the regrowth of nerve fibers with NEUROGEL™,  the patient will have to undergo a long and intensive rehabilitation in a physiotherapy center.   Concurrently, he will receive a hormonal treatment of EPO + progesterone.

LENGTH OF THE CLINICAL TRIAL

The estimated length of the clinical trial for the patient is one year minimum,  spent mostly in a physiotherapy center.

For the promoter, this clinical trial will involve two stages: setting up a system of quality management and preparing a technical dossier to obtain CE accreditation (CE= Communaute Europenne = European Union.)  The process  of obtaining CE accreditation takes a minimum of two years, from the beginning of the trial.