Complete Spinal Cord InjuriesPhase 1NCT01231893
Transplantation of Autologous Olfactory Ensheathing Cells in Complete Human Spinal Cord Injury
A Phase 1 study testing olfactory mucosa ensheathing cell grafting, rehabilitation and rehabilitation in people with Complete Spinal Cord Injuries, run by Wroclaw Medical University at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Complete Spinal Cord Injuries
- What is being tested?
- olfactory mucosa ensheathing cell grafting, rehabilitation and rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 sitePoland
- Study dates
- May 2008to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Show all 10Show fewer
- chronic sinusitis
- tumors or polyps of nasal cavities
- persistent hyposmia or anosmia
- pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Neurosurgery of Wroclaw Medical University
Wroclaw, 50-556
Pawel Tabakow, M.D. Ph.D.
Wlodzimierz Jarmundowicz, M.D. Ph.D.
About this study
Official title: Transplantation of Autologous Olfactory Ensheathing Cells for Treatment of Complete Human Spinal Cord Injuries- a Phase I Clinical Trial.
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.
Read the detailed description
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
- Complete Spinal Cord Injuries
- Being tested
- olfactory mucosa ensheathing cell grafting, rehabilitation, rehabilitation
- Keywords
- human, spinal cord injury, olfactory ensheathing cells, transplantation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olfactory mucosa ensheathing cell grafting, rehabilitationProcedure or surgery
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.
rehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| olfactory ensheathing cell recipient | Experimental | Not described Receives: Procedure: olfactory mucosa ensheathing cell grafting, rehabilitation |
| control | Active comparator | Not described Receives: Other: rehabilitation |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
- Study startMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences, Department of Rehabilitation in Spinal Cord Injuries Akson
- Investigators
- Wlodzimierz Jarmundowicz, M.D. Ph.D., Study director, Department of Neurosurgery of Wroclaw Medical UniversityPawel Tabakow, M.D. Ph.D., Principal investigator, Department of Neurosurgery of Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231893
- Sponsor's protocol ID
- SR 406
- Status last verified
- Oct 2010
- First submitted
- 29 Oct 2010
- Last updated
- 1 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transplantation of Autologous Olfactory Ensheathing Cells for Treatment of Complete Human Spinal Cord Injuries- a Phase I Clinical Trial.
- ClinicalTrials.gov ID
- NCT01231893
- Acronym / sponsor ID
- SR 406
- Conditions
- Complete Spinal Cord Injuries
- Keywords
- human, spinal cord injury, olfactory ensheathing cells, transplantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Collaborators
- Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences, Department of Rehabilitation in Spinal Cord Injuries Akson
- Study start
- May 2008
- First posted
- 1 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| olfactory ensheathing cell recipient | Experimental | Procedure: olfactory mucosa ensheathing cell grafting, rehabilitation |
| control | Active comparator | Other: rehabilitation |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- a coexisting lesion of the nervous system
- progressive post-traumatic syringomyelia
- significant spinal stenosis or instability
- persistent neuropathic pain
- muscle atrophy or joint ossifications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| olfactory mucosa ensheathing cell grafting, rehabilitationIn 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. | Procedure or surgery | olfactory ensheathing cell recipient |
| rehabilitationIn 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. | Other | control |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2010.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wlodzimierz Jarmundowicz, M.D. Ph.D. study director
Department of Neurosurgery of Wroclaw Medical University
Pawel Tabakow, M.D. Ph.D. principal investigator
Department of Neurosurgery of Wroclaw Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing olfactory mucosa ensheathing cell grafting, rehabilitation and rehabilitation in people with Complete Spinal Cord Injuries, run by Wroclaw Medical University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pawel Tabakow, M.D. Ph.D. (48 606 137 846, p.tabakov@wp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2010.