Chronic Spinal Cord InjuryPhase 1/2NCT00816803
Cell Transplant in Spinal Cord Injury Patients
A Phase 1/2 study testing Autologous bone marrow transplant and Physical therapy in people with Chronic Spinal Cord Injury, run by Cairo University at 1 site in Egypt.
Trial summary
This study is designed to assess the safety of autologous bone marrow derived cell transplant in chronic spinal cord injury patients. The hypothesis is that the availability of bone marrow derived mesenchymal stem cells at the sites of injury promote neuronal regeneration. Read more about this study
- Who is it for?
- Ages 10 to 36 years
- Conditions the study is for
- Chronic Spinal Cord Injury
- What is being tested?
- Autologous bone marrow transplant and Physical therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- May 2005to Dec 2008
- Phase
- Phase 1/2
- 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 10 to 36 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Traumatic spinal cord injury
- No concomitant systemic disease
- No progress on physiotherapy for at least 6 months
- Duration of injury from 10 months to 3 years
Who cannot join
- Non-traumatic spinal cord injury whether transverse myelitis or demyelination
- Concomitant systemic disease
- Progress can be observed on physiotherapy
- Acute injury or duration of injury less than 10 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autologous Bone Marrow Derived Cell Transplant in Spinal Cord Injury Patients
This study is designed to assess the safety of autologous bone marrow derived cell transplant in chronic spinal cord injury patients. The hypothesis is that the availability of bone marrow derived mesenchymal stem cells at the sites of injury promote neuronal regeneration.
- Conditions
- Chronic Spinal Cord Injury
- Being tested
- Autologous bone marrow transplant, Physical therapy
- Keywords
- Spinal cord injury
- 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.
Autologous bone marrow transplantProcedure or surgery
Physical therapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| BM transplant with physiotherapy | Experimental | Autologous BM transplant Receives: Procedure: Autologous bone marrow transplant; Procedure: Physical therapy |
| Physiotherapy only | Active comparator | conventional physical therapy for chronic spinal cord injury. Receives: Procedure: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of autologous BM transplant measured by absence of neuronal changes, infections or increased intracranial tension, and monitoring for any abnormal growth or tumor formation by MRI.
Measured: 18 months
Secondary outcomes (1)
Efficacy of BM cell transplant in improving neurological functions in patients with chronic SCI. Improvement in motor, sensory and sphincteric functions, and quality of life using ASIA scores and MRI.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2009 (estimated)
- Study startMay 2005
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Azhar University, Medical Military Academy, Egypt, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816803
- Sponsor's protocol ID
- EGY-SCI-1
- Status last verified
- Jan 2009
- First submitted
- 31 Dec 2008
- Last updated
- 5 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
El-Kheir WA, Gabr H, Awad MR, Ghannam O, Barakat Y, Farghali HA, El Maadawi ZM, Ewes I, Sabaawy HE. Autologous bone marrow-derived cell therapy combined with physical therapy induces functional improvement in chronic spinal cord injury patients. Cell Transplant. 2014 Apr;23(6):729-45. doi: 10.3727/096368913X664540. Epub 2013 Feb 26.
PubMed 23452836
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Bone Marrow Derived Cell Transplant in Spinal Cord Injury Patients
- ClinicalTrials.gov ID
- NCT00816803
- Acronym / sponsor ID
- EGY-SCI-1
- Conditions
- Chronic Spinal Cord Injury
- Keywords
- Spinal cord injury
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Al-Azhar University, Medical Military Academy, Egypt, Alexandria University
- Study start
- May 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 5 Jan 2009 (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.
This study is designed to assess the safety of autologous bone marrow derived cell transplant in chronic spinal cord injury patients. The hypothesis is that the availability of bone marrow derived mesenchymal stem cells at the sites of injury promote neuronal regeneration.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BM transplant with physiotherapy | Experimental | Procedure: Autologous bone marrow transplant, Procedure: Physical therapyAutologous BM transplant |
| Physiotherapy only | Active comparator | Procedure: Physical therapyconventional physical therapy for chronic spinal cord injury. |
Who may qualify
- Ages
- 10 to 36 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Traumatic spinal cord injury
- No concomitant systemic disease
- No progress on physiotherapy for at least 6 months
- Duration of injury from 10 months to 3 years
Key exclusion criteria (4 listed)
- Non-traumatic spinal cord injury whether transverse myelitis or demyelination
- Concomitant systemic disease
- Progress can be observed on physiotherapy
- Acute injury or duration of injury less than 10 months
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 |
|---|---|---|
| Autologous bone marrow transplant | Procedure or surgery | BM transplant with physiotherapy |
| Physical therapy | Procedure or surgery | BM transplant with physiotherapy, Physiotherapy only |
Primary outcome
Safety of autologous BM transplant measured by absence of neuronal changes, infections or increased intracranial tension, and monitoring for any abnormal growth or tumor formation by MRI.
Time frame: 18 months
1 secondary outcome
Efficacy of BM cell transplant in improving neurological functions in patients with chronic SCI. Improvement in motor, sensory and sphincteric functions, and quality of life using ASIA scores and MRI.
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2009.
- Derived from this study: PubMed 23452836El-Kheir WA, Gabr H, Awad MR, Ghannam O, Barakat Y, Farghali HA, El Maadawi ZM, Ewes I, Sabaawy HE. Autologous bone marrow-derived cell therapy combined with physical therapy induces functional improvement in chronic spinal cord injury patients. Cell Transplant. 2014 Apr;23(6):729-45. doi: 10.3727/096368913X664540. Epub 2013 Feb 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous bone marrow transplant and Physical therapy in people with Chronic Spinal Cord Injury, run by Cairo University at 1 site in Egypt.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 5 Jan 2009. 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 Egypt. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of autologous BM transplant measured by absence of neuronal changes, infections or increased intracranial tension, and monitoring for any abnormal growth or tumor formation by MRI. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00816803, which also lists 1 linked publication.
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 5 Jan 2009.