MedDataX Logo

Transplantation of Autologous Olfactory Ensheathing Cells in Complete Human Spinal Cord Injury

NCT ID: NCT01231893

Last Updated: 2010-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this experimental therapy is an assessment of the safety and feasibility of transplantation of autologous olfactory ensheathing glia and olfactory fibroblasts obtained from the olfactory mucosa in patients with complete spinal cord injury.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The increasing number of patients (mostly young), who have sustained a spinal cord injury mainly as a result of motor vehicle accidents, falls or violence has become worldwide a serious clinical, social and economical problem. Most accepted treatment protocols for spinal cord injury focus on techniques of early neuro-protection aimed at maximal prevention of secondary spinal cord injury (administration of methylprednisolon and spinal cord surgical decompression) as well as on methods of stimulation of plasticity in the central nervous system (neurorehabilitation). While these methods have been shown to stimulate functional recovery in patients with incomplete spinal cord injury, the results of treatment of patients with severe incomplete and complete spinal cord injuries remain unsatisfactory. This is due to the lack of spontaneous regeneration of lesioned axons in the spinal cord. Results from a substantial number of animal experiments performed mainly on the model of mammalian spinal cord injury in the last 3 decades led to the establishment of numerous regeneration-promoting strategies including application of neurotrophic factors, antibodies blocking the myelin-associated proteins and transplantation of cells with neurotrophic activity. Olfactory ensheathing cells (OECs) are an unique population of macroglia found in the lamina propria of olfactory mucosa, around the olfactory nerve fascicles and in the two outer layers of the olfactory bulb. These cells have the natural ability to stimulate the regrowth of lesioned peripheral and central axons. In a Phase I non-randomized controlled prospective study we have tested the hypothesis that a combined approach for treatment of complete spinal cord injuries consisting of intraspinal transplantation of a mixture of autologous OECs and fibroblasts isolated from the olfactory mucosa, combined with intense neuro-rehabilitation is safe and feasible.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Complete Spinal Cord Injuries

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

human, spinal cord injury, olfactory ensheathing cells, transplantation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

olfactory ensheathing cell recipient

Group Type EXPERIMENTAL

olfactory mucosa ensheathing cell grafting, rehabilitation

Intervention Type PROCEDURE

In this group patients are planned to underwent a biopsy of their own olfactory mucosa for isolation and culture of olfactory ensheathing cells and olfactory fibroblasts. The suspension of these cells will be next transplanted into the focus of spinal cord injury. Before and after surgery the patients will undergo an intense neurorehabilitation program.

control

Group Type ACTIVE_COMPARATOR

rehabilitation

Intervention Type OTHER

In this group the patients will not undergo any surgical procedure. They will participate in the same rehabilitation protocol that is planned for the patients from the experimental group.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

olfactory mucosa ensheathing cell grafting, rehabilitation

In this group patients are planned to underwent a biopsy of their own olfactory mucosa for isolation and culture of olfactory ensheathing cells and olfactory fibroblasts. The suspension of these cells will be next transplanted into the focus of spinal cord injury. Before and after surgery the patients will undergo an intense neurorehabilitation program.

Intervention Type PROCEDURE

rehabilitation

In this group the patients will not undergo any surgical procedure. They will participate in the same rehabilitation protocol that is planned for the patients from the experimental group.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* spinal cord injury at subacute or chronic stage
* a single spinal cord injury between segments C5 and L5
* myelopathy confirmed by MRI, not exceeding 2 spinal cord segments
* loss of sensory and motor function below the injury, confirmed in control studies (ASIA Category A)
* age from 16 to 65 years
* patient undergoing continuous rehabilitation
* good patient motivation and cooperation
* signed informed consent

Exclusion Criteria

* a coexisting lesion of the nervous system
* progressive post-traumatic syringomyelia
* significant spinal stenosis or instability
* persistent neuropathic pain
* muscle atrophy or joint ossifications
* severe systemic disease (neoplasm, contagious disease, diabetes etc.)
* chronic sinusitis
* tumors or polyps of nasal cavities
* persistent hyposmia or anosmia
* pregnant or breastfeeding women
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences

OTHER

Sponsor Role collaborator

Department of Rehabilitation in Spinal Cord Injuries Akson

UNKNOWN

Sponsor Role collaborator

Wroclaw Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Department of Neurosurgery of the Wroclaw Medical University

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wlodzimierz Jarmundowicz, M.D. Ph.D.

Role: STUDY_DIRECTOR

Department of Neurosurgery of Wroclaw Medical University

Pawel Tabakow, M.D. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Neurosurgery of Wroclaw Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Neurosurgery of Wroclaw Medical University

Wroclaw, , Poland

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Poland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Pawel Tabakow, M.D. Ph.D.

Role: CONTACT

Phone: 48 606 137 846

Email: [email protected]

Wlodzimierz Jarmundowicz, M.D. Ph.D.

Role: CONTACT

Phone: 48 601 706 816

Email: [email protected]

Related Links

Access external resources that provide additional context or updates about the study.

http://www.sci-therapies.info

Related Info

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SR 406

Identifier Type: -

Identifier Source: org_study_id