Autologous Bulbar Olfactory Ensheathing Cells and Nerve Grafts for Treatment of Patients With Spinal Cord Transection

Summary

The purpose of this experimental therapy is to evaluate the safety and efficacy of transplantation of autologous olfactory ensheathing cells (OECs) and olfactory nerve fibroblasts (ONFs) obtained from the olfactory bulb with simultaneous reconstruction of the posttraumatic spinal cord gap with peripheral nerve grafts, in patients with chronic complete spinal cord injury. The treatment will be performed in two patients that have sustained an anatomically complete spinal cord transection between the spinal cord segments C5 and Th10.

All patients wanting to participate in this study have to send their application at the address:

walk-again-project.org

Conditions

• Spinal Cord Injury at C5-Th10 Level With Complete Lesion
• Spinal Cord Transection

Interventions

PROCEDURE

obtaining of autologous human olfactory bulb, autologous sural nerve preparation

The operative procedure will be aimed to obtain one of the patient's olfactory bulbs. The operation will be performed using a minimally invasive intracranial microsurgical endoscopy-assisted or transnasal endoscopic approach. During the same operation the patient sural nerve will be prepared for a future grafting.

BIOLOGICAL

production of Glial Neuropatch

The human autologous olfactory ensheathing glia and olfactory fibroblast isolated from the olfactory bulb will be used for production of Glial Neuropatch in a laboratory facility in accordance with good manufacture procedures (GMP). The final Product will consist of the aforementioned cell suspension embedded with collagen scaffold. The European Medicines Agency/Committee for Advanced Therapies (EMA/CAT) considers that the Product Glial Neuropatch falls within the definition of a tissue engineered product of an advanced therapy medicinal product (decision EMA/CAT/293903/2018 from 22 June 2018: Scientific recommendation on classification of advanced therapy medicinal products Article 17 - Regulation (EC) No 1394/2007).

PROCEDURE

microsurgical reconstruction of the transected spinal cord with autologous Glial Neuropatch-nerve bridges

The surgery will consists of laminectomy/laminotomy, midline durotomy above the area of spinal cord lesion, detethering of the spinal cord from fibrotic adhesions, resection of the posttraumatic spinal cord glial scar, delivering of cultured OEC/ONFs explants (Glial Neuropatch) to the area of spinal cord injury and finally bridging of the spinal cord gap by harvested autologous sural nerve grafts.

Sponsors & Collaborators

• Wroclaw Medical University

  collaborator OTHER

• Akson, Neuro-Rehabilitation Center for the Treatment of Spinal Cord Injuries

  collaborator UNKNOWN

• University College, London

  collaborator OTHER

• Poznan University of Medical Sciences

  collaborator OTHER

• Nicholls Spinal Injury Foundation

  lead OTHER

Principal Investigators

• Pawel Tabakow, MD PhD · Wroclaw Medical University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

16 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-03-01

Primary Completion

2023-03-01

Completion

2023-03-01

Countries

• Poland

Study Locations