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Spinal cord injury regeneration using a marine bio-based hydrogel to be transfered from a French Technology Transfer Office.

Country of Origin: France
Reference Number: TOFR20180614001
Publication Date: 14 June 2018

Summary

An innovative scaffold for spinal cord injury indication has been fully investigated on both small and medium animal models, by a research lab in the Paris region. The French Technology Transfer Office (TTO) acting on behalf the research lab, is looking for a licensing agreement. The requested partner may be any medical device or pharmaceutical company operating in the spinal cord injury recovery process, with a view to conduct further clinical trials.

Description

A French Technology Transfer Office (TTO) is acting on behalf several major engineering and medical schools in the Paris region. A research team operating in biomechanical and tissue engineering has developed an innovative scaffold that promotes spinal tissue growing and motion coordination recovery.

* Market challlenges :
Spinal cord injury is strongly correlated with rough falls when climbing, car or motorcycle crashes when driving or by any crash involving the backbone. It can also be a direct result of any spinal disease or degeneration. The worldwide prevalence is about 250,000 and 500,000 patients. The incidental extra cost (including the global economic loss in addition to patients care) is very huge (from1.5 to 4.7 millions $) since there is still no appropriate recovery solution, either by surgery and/or drug delivery.

* State of the art :
There is no suitable biomaterial on the market that may be relevant for the spinal cord injury indication. Until now, only a few materials are under research investigation. Moreover, such results haven't reached the clinical milestone yet because of an obvious major issue : it is strongly difficult to set up a cohort of post-trauma patients only a few hours after beeing crashed or injured.
The only operation that is performed whenever enough safety requirements are met is a corrective or restorative surgery using the remaining living tissue, and leads to unreliable results.
As a consequence, there is a strong need for a biocompatible scaffold with a potential for :
- myelination of the remaining axones (myeline is the protective layer around nervous fibers), and
- angiogenesis (growing of new blood vessels from existing ones).

* Proposed technology :
Chitosan is a biocompatible material made from the chitin shells of shrimp and other crustaceans after a specific treatment using an alkaline substance, such as sodium hydroxide. Chitosan is known to have a bleeding reduction effect in bandages and is also an antibacterial agent. As an example, It is also known to help the drug delivery through the skin.
A chitosan-based innovative scaffold for spinal cord regeneration has been set up and patented in a Paris region research lab working in biomechanical and tissue engineering. It consists in an hydrogel suspension for use as a class III medical device according to the European regulation 2017/745.

Pre-clinical investigation has been performed on rats. The following results have been observed :
- the regeneration of spinal tissue and blood vessels,
- the regrowth of axones with remyelination.
The resulting function recovery on motion coordination has been evaluated using the ASIA scale from the American Spinal Injury Association as a reference. The locomotor function recovery score has been found to be 18/21 on rats. Investigation on dogs is in process with preliminary results that confirm the above-mentioned ones.

The requested partner may be any medical device or pharmaceutical company operating in spinal cord injury recovery process, with a view to conduct further clinical trials.
The French TTO is looking for a licensing agreement with such companies prior to the clinical investigation.

*Keywords :
central nervous system, spinal cord injury, nerve repair, medical device, hydrogel, chitosan
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Advantages and Innovations

The innovative marine bio-based hydrogel set up and patented by the Paris region research team, is a class III medical device for a cutting-edge curative treatment of the spinal cord injury.

The innovation consists in a chitosan-based hydrogel which is fully biocompatible. Above all, it is fully consistent with any 3D geometry of the damaged or impaired tissue area.

For the first time, the proposed innovation makes the spinal cord restorative surgery possible in appropriate conditions.

The spinal cord surgery using a marine bio-based scaffold has got the following advantages :
- no crosslink agent is needed to insure biocompatibility,
- no stem cells are needed for tissue regeneration,
- no any active principle ingredient (API) is needed,
- production of the innovative scaffold is affordable.

Stage Of Development

Field tested/evaluated

Stage Of Development Comment

The innovative scaffold to be used in spinal cord surgery has been investigated on both small and medium animal models.

The locomotor function recovery score has been found to be 18/21 on rats, with respect to the ASIA scale (see description section).

Investigation on dogs is in process with preliminary results that confirm those found on small animal model.

Requested partner

The requested partner may be any medical device or pharmaceutical company operating in spinal cord injury recovery process, with a view to conduct further clinical trials.

The French TTO is looking for a licensing agreement with such companies prior to the clinical investigation.

Cooperation offer is closed for requests