Autologous Bulbar Olfactory Ensheathing Cells and Nerve Grafts for Treatment of Patients With Spinal Cord Transection
NCT ID: NCT03933072
Last Updated: 2021-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
2 participants
INTERVENTIONAL
2016-03-01
2023-03-01
Brief Summary
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All patients wanting to participate in this study have to send their application at the address:
walk-again-project.org
Detailed Description
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The main goal of the study is to answer the question if there is possible to evoke functional regeneration of severed spinal cord axons after a two-stage surgical intervention in patients sustaining a complete spinal cord transection between the spinal cord segments C5 and Th10. Patients with clinically, electrophysiologically and radiologically features of complete spinal cord injury will undergo an 8-month neurorehabilitation regimen. Patients who will not show electrophysiological and clinical signs of recovery from the spinal cord injury will enter the surgical part of the study.
During the first surgery the patient's own olfactory bulb will be obtained. The human autologous olfactory ensheathing glia and olfactory fibroblast isolated from the olfactory bulb will be used for production of Glial Neuropatch in accordance with the methodology adjusted in grant number GR-797/NCN/2013 and 2012/06/M/NZ4/00138, in a laboratory facility, in accordance with the 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).
The second surgery will consist of laminectomy/laminotomy, midline durotomy above the area of spinal cord lesion, detethering of the spinal cord from fibrous 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.
After discharge from the hospital, the patients will be subjected to a minimum 2-year neurorehabilitation in accordance with the same program as before the operation.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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patients with complete spinal cord injury
the planned interventions have been described in the section below
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.
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).
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.
Interventions
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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.
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).
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.
Eligibility Criteria
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Inclusion Criteria
2. Myelopathy not exceeding 2 spinal cord segments as confirmed by MRI.
3. Complete loss of sensory and motor function below the injury, confirmed in serial control clinical studies (ASIA Category A) and neurophysiological studies (MEP, SSR, EPT, EMG, ENG, von Frey's filaments)
4. Age from 16 to 65 years.
5. Patient undergoing continuous rehabilitation.
6. Good patient motivation and cooperation, no mental disturbances.
7. Patient is ready to stay with an accompanying person for at least 3 years in Poland.
8. Patient without cardiac disease and without epilepsy, does not have peacemaker or any electronic or ferromagnetic implants.
Exclusion Criteria
2. Progressive post-traumatic syringomyelia.
3. Significant spinal stenosis or instability.
4. Muscle atrophy or joint ossifications.
5. Severe systemic disease such as neoplasm, contagious disease, diabetes etc.
6. Chronic sinusitis destroying the paranasal sinuses, tumors of nasal cavities or patients with hyposmia in repetitive smell perception tests will be excluded.
7. Implants or the health status described in point 8 (see above).
Note: All patients wanting to participate in this study have to send their application via the walk-again-project.org recruitment website!
16 Years
65 Years
ALL
No
Sponsors
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Wroclaw Medical University
OTHER
Akson, Neuro-Rehabilitation Center for the Treatment of Spinal Cord Injuries
UNKNOWN
University College, London
OTHER
Poznan University of Medical Sciences
OTHER
Nicholls Spinal Injury Foundation
OTHER
Responsible Party
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Dr. Pawel Tabakow
Ass. Professor, MD PhD
Principal Investigators
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Pawel Tabakow, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Wroclaw Medical University
Locations
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Wroclaw Medical University
Wroclaw, , Poland
Countries
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Central Contacts
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Facility Contacts
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Pawel Tabakow, MD PhD
Role: primary
Aleksandra Nowak, Dr
Role: backup
References
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Tabakow P, Raisman G, Fortuna W, Czyz M, Huber J, Li D, Szewczyk P, Okurowski S, Miedzybrodzki R, Czapiga B, Salomon B, Halon A, Li Y, Lipiec J, Kulczyk A, Jarmundowicz W. Functional regeneration of supraspinal connections in a patient with transected spinal cord following transplantation of bulbar olfactory ensheathing cells with peripheral nerve bridging. Cell Transplant. 2014;23(12):1631-55. doi: 10.3727/096368914X685131. Epub 2014 Oct 21.
Tabakow P, Jarmundowicz W, Czapiga B, Fortuna W, Miedzybrodzki R, Czyz M, Huber J, Szarek D, Okurowski S, Szewczyk P, Gorski A, Raisman G. Transplantation of autologous olfactory ensheathing cells in complete human spinal cord injury. Cell Transplant. 2013;22(9):1591-612. doi: 10.3727/096368912X663532.
Collins A, Li D, Liadi M, Tabakow P, Fortuna W, Raisman G, Li Y. Partial Recovery of Proprioception in Rats with Dorsal Root Injury after Human Olfactory Bulb Cell Transplantation. J Neurotrauma. 2018 Jun 15;35(12):1367-1378. doi: 10.1089/neu.2017.5273. Epub 2018 Mar 29.
Ibrahim A, Li D, Collins A, Tabakow P, Raisman G, Li Y. Comparison of olfactory bulbar and mucosal cultures in a rat rhizotomy model. Cell Transplant. 2014;23(11):1465-70. doi: 10.3727/096368913X676213. Epub 2013 Dec 30.
Czyz M, Tabakow P, Hernandez-Sanchez I, Jarmundowicz W, Raisman G. Obtaining the olfactory bulb as a source of olfactory ensheathing cells with the use of minimally invasive neuroendoscopy-assisted supraorbital keyhole approach--cadaveric feasibility study. Br J Neurosurg. 2015 Jun;29(3):362-70. doi: 10.3109/02688697.2015.1006170. Epub 2015 Feb 7.
Czyz M, Tabakow P, Gheek D, Mis M, Jarmundowicz W, Raisman G. The supraorbital keyhole approach via an eyebrow incision applied to obtain the olfactory bulb as a source of olfactory ensheathing cells--radiological feasibility study. Br J Neurosurg. 2014 Apr;28(2):234-40. doi: 10.3109/02688697.2013.817534. Epub 2013 Jul 19.
Other Identifiers
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Wroclaw Walk Again Project
Identifier Type: -
Identifier Source: org_study_id