Phase 1 Safety Trial of Autologous Human Schwann Cell Transplantation in Chronic Spinal Cord Injury.

Adult Cell Transplantation Female Humans Lumbar Vertebrae / injuries Magnetic Resonance Imaging Male Middle Aged Schwann Cells / transplantation Spinal Cord Injuries / surgery Sural Nerve Thoracic Vertebrae / injuries Transplantation, Autologous Treatment Outcome
Schwann cells autologous transplantation chronic human paraplegia spinal cord injury

Journal

Journal of neurotrauma
ISSN: 1557-9042
Titre abrégé: J Neurotrauma
Pays: United States
ID NLM: 8811626

Informations de publication

Date de publication:
02 2022
Historique:
pubmed: 25 3 2021
medline: 19 3 2022
entrez: 24 3 2021
Statut: ppublish

Résumé

A phase 1 open-label, non-randomized clinical trial was conducted to determine feasibility and safety of autologous human Schwann cell (ahSC) transplantation accompanied by rehabilitation in participants with chronic spinal cord injury (SCI). Magnetic resonance imaging (MRI) was used to screen eligible participants to estimate an individualized volume of cell suspension to be implanted. The trial incorporated standardized multi-modal rehabilitation before and after cell delivery. Participants underwent sural nerve harvest, and ahSCs were isolated and propagated in culture. The dose of culture-expanded ahSCs injected into the chronic spinal cord lesion of each individual followed a cavity-filling volume approach. Primary outcome measures for safety and trend-toward efficacy were assessed. Two participants with American Spinal Injury Association Impairment Scale (AIS) A and two participants with incomplete chronic SCI (AIS B, C) were each enrolled in cervical and thoracic SCI cohorts (

Identifiants

DOI: 10.1089/neu.2020.7590 PMID: 33757304 PMC: PMC9360180
pubmed: 33757304
doi: 10.1089/neu.2020.7590
pmc: PMC9360180
doi:

Types de publication

Clinical Trial, Phase I Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

285-299

Subventions

Organisme : NIA NIH HHS
ID : L30 AG060558
Pays : United States
Organisme : NIA NIH HHS
ID : R01 AG055638
Pays : United States

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Auteurs

Katie L Gant (KL)

The Miami Project to Cure Paralysis, University of Miami, Miami, Florida, USA.
Department of Neurological Surgery, University of Miami, Miami, Florida, USA.

James D Guest (JD)

The Miami Project to Cure Paralysis, University of Miami, Miami, Florida, USA.
Department of Neurological Surgery, University of Miami, Miami, Florida, USA.
Department of Neuroscience, University of Miami, Miami, Florida, USA.

Anne E Palermo (AE)

The Miami Project to Cure Paralysis, University of Miami, Miami, Florida, USA.
Department of Neurological Surgery, University of Miami, Miami, Florida, USA.

Aditya Vedantam (A)

The Miami Project to Cure Paralysis, University of Miami, Miami, Florida, USA.
Department of Neurological Surgery, University of Miami, Miami, Florida, USA.

George Jimsheleishvili (G)

The Miami Project to Cure Paralysis, University of Miami, Miami, Florida, USA.
Department of Neurological Surgery, University of Miami, Miami, Florida, USA.

Mary Bartlett Bunge (MB)

The Miami Project to Cure Paralysis, University of Miami, Miami, Florida, USA.
Department of Neurological Surgery, University of Miami, Miami, Florida, USA.
Department of Neuroscience, University of Miami, Miami, Florida, USA.
Department of Cell Biology, University of Miami, Miami, Florida, USA.
Department of Neurology, University of Miami, Miami, Florida, USA.
Department of Interdisciplinary Stem Cell Institute, University of Miami, Miami, Florida, USA.

Adriana E Brooks (AE)

The Miami Project to Cure Paralysis, University of Miami, Miami, Florida, USA.
Department of Interdisciplinary Stem Cell Institute, University of Miami, Miami, Florida, USA.

Kim D Anderson (KD)

Department of Physical Medicine and Rehabilitation, Case Western Reserve University, Metrohealth Medical Center, Cleveland, Ohio, USA.

Christine K Thomas (CK)

The Miami Project to Cure Paralysis, University of Miami, Miami, Florida, USA.
Department of Neurological Surgery, University of Miami, Miami, Florida, USA.

Andrea J Santamaria (AJ)

The Miami Project to Cure Paralysis, University of Miami, Miami, Florida, USA.
Department of Neurological Surgery, University of Miami, Miami, Florida, USA.

Monica A Perez (MA)

The Miami Project to Cure Paralysis, University of Miami, Miami, Florida, USA.
Department of Neurological Surgery, University of Miami, Miami, Florida, USA.
Bruce W. Carter Department of Veterans Affairs Medical Center, Miami, Florida, USA.
Shirley Ryan AbilityLab, Northwestern University, Edward Hines Jr, VA Hospital, Chicago, Illinois, USA.

Rosie Curiel (R)

Department of Psychiatry, University of Miami, Miami, Florida, USA.

Mark S Nash (MS)

Department of Rehabilitation Medicine, University of Miami, Miami, Florida, USA.

Efrat Saraf-Lavi (E)

Department of Radiology, University of Miami, Miami, Florida, USA.

Damien D Pearse (DD)

Department of Neuroscience, University of Miami, Miami, Florida, USA.
Department of Interdisciplinary Stem Cell Institute, University of Miami, Miami, Florida, USA.
Bruce W. Carter Department of Veterans Affairs Medical Center, Miami, Florida, USA.
Shirley Ryan AbilityLab, Northwestern University, Edward Hines Jr, VA Hospital, Chicago, Illinois, USA.

Eva Widerström-Noga (E)

The Miami Project to Cure Paralysis, University of Miami, Miami, Florida, USA.
Department of Neurological Surgery, University of Miami, Miami, Florida, USA.
Department of Neuroscience, University of Miami, Miami, Florida, USA.
Department of Rehabilitation Medicine, University of Miami, Miami, Florida, USA.
Bruce W. Carter Department of Veterans Affairs Medical Center, Miami, Florida, USA.

Aisha Khan (A)

The Miami Project to Cure Paralysis, University of Miami, Miami, Florida, USA.
Department of Interdisciplinary Stem Cell Institute, University of Miami, Miami, Florida, USA.

W Dalton Dietrich (WD)

The Miami Project to Cure Paralysis, University of Miami, Miami, Florida, USA.
Department of Neurological Surgery, University of Miami, Miami, Florida, USA.
Department of Neuroscience, University of Miami, Miami, Florida, USA.
Department of Cell Biology, University of Miami, Miami, Florida, USA.
Department of Neurology, University of Miami, Miami, Florida, USA.
Department of Interdisciplinary Stem Cell Institute, University of Miami, Miami, Florida, USA.

Allan D Levi (AD)

The Miami Project to Cure Paralysis, University of Miami, Miami, Florida, USA.
Department of Neurological Surgery, University of Miami, Miami, Florida, USA.
Department of Neuroscience, University of Miami, Miami, Florida, USA.

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Classifications MeSH

questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Phase 1 Safety Trial of Autologous Human...
questionsmedicales.fr › Procédures de chirurgie opératoire › Transplantation › Transplantation cellulaire › Phase 1 Safety Trial of Autologous Human...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Phase 1 Safety Trial of Autologous Human...
questionsmedicales.fr › Appareil locomoteur › Squelette › Rachis › Vertèbres lombales › Phase 1 Safety Trial of Autologous Human...
questionsmedicales.fr › Diagnostic › Techniques et procédures diagnostiques › Imagerie diagnostique › Tomographie › Imagerie par résonance magnétique › Phase 1 Safety Trial of Autologous Human...
questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Adulte d'âge moyen › Phase 1 Safety Trial of Autologous Human...
questionsmedicales.fr › Cellules › Névroglie › Cellules de Schwann › Phase 1 Safety Trial of Autologous Human...
questionsmedicales.fr › Plaies et blessures › Traumatismes de la moelle épinière › Phase 1 Safety Trial of Autologous Human...
questionsmedicales.fr › Système nerveux › Système nerveux périphérique › Nerfs périphériques › Nerfs spinaux › Plexus lombosacral › Nerf ischiatique › Nerf tibial › Nerf sural › Phase 1 Safety Trial of Autologous Human...
questionsmedicales.fr › Appareil locomoteur › Squelette › Rachis › Vertèbres thoraciques › Phase 1 Safety Trial of Autologous Human...
questionsmedicales.fr › Procédures de chirurgie opératoire › Transplantation › Transplantation autologue › Phase 1 Safety Trial of Autologous Human...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Évaluation des résultats et des processus en soins de santé › Évaluation de résultat (soins) › Résultat thérapeutique › Phase 1 Safety Trial of Autologous Human...