Spinal Cord InjuryPhase 1/2ABSCINCT01730183
To Study the Safety and Efficacy of Autologous Bone Marrow Stem Cells in Patients With Spinal Cord Injury
A Phase 1/2 study testing Bone marrow derived stem cells in people with Spinal Cord Injury, run by Max Institute of Neurosciences at 1 site in India.
Trial summary
This is a Phase I/II, multicenter, prospective, non-randomized, open label study to evaluate the safety/efficacy of autologous bone marrow-derived stem cell transplantation in spinal cord injury patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Bone marrow derived stem cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2012to Nov 2014
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Traumatic injury of the spinal cord (below C5 level) occurring within 6 months to 8 years prior to treatment, resulting in a sustained and complete / Partial loss of sensory and motor function below the injury (ASIA Category A, B and C ).
- Confirmation spinal cord injury level (Patients with complete or partial transection/damage by MRI).
- Those provide fully informed consent.
- The level of spinal cord injury must be below C4.
Who cannot join
- Spinal vertebral instability.
- Major concurrent medical illness (e.g. carcinoma, auto-immune disease,)
- ASIA Impairment Scale category other than D \& E.
- Lactating and pregnant women.
- Syringomyelia is also an exclusion criterion but an exemption can be made for a patient with a stable syrinx.
- Platelet count greater than 100 thousand/µl at screening.
Show all 9Show fewer
- Hematocrit less than 30% prior to bone marrow aspiration.
- Patients with major and current psychiatric illness.
- Significant traumatic brain injury associated with the spinal cord injury.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Max Super speciality Hospital
Dehradun, Uttrakhand, 248001
+91-8800255922, dr.ydewanneuro@gmail.com
Yashbir Dewan, MS, MCh
About this study
Official title: To Study the Safety and Efficacy of Autologous Bone Marrow Stem Cells in Patients With Spinal Cord Injury (SCI)
This is a Phase I/II, multicenter, prospective, non-randomized, open label study to evaluate the safety/efficacy of autologous bone marrow-derived stem cell transplantation in spinal cord injury patients.
Read the detailed description
Spinal cord injury (SCI) is a traumatic disorder resulting in a functional deficit that usually leads to severe and permanent paralysis and the projected data related to the burden of spinal cord injuries across the globe is quite alarming. Pharmacological and rehabilitation therapies to SCI have got limited effect. There is definitely an urgent need for finding different methods of treatment for these patients who cannot undergo established modalities of treatment or these have been tried unsuccessfully. Another promising therapeutic approach for SCI is "Stem cell transplantation". Bone marrow derived stem cells have been shown to promote anatomical and functional recovery in animal models of SCI by promoting tissue sparing, axonal regeneration, and remyelination. In our present study, we want to evaluate the safety and efficacy of autologous bone marrow derived stem cells surgically transplanted intrathecally into patients with spinal cord injury.
- Conditions
- Spinal Cord Injury
- Being tested
- Bone marrow derived stem cells
- 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.
Bone marrow derived stem cellsOther
Also called Bone Marrow derived Mononucleated stem cell (BMMNCs)
Intrathecal administration of autologous bone marrow derived stem cells upto a cell dose of equal or greater than 10(8)BMMNCs.
| Study group | Role | What they receive |
|---|---|---|
| Bone marrow derived stem cells | Experimental | Autologous Bone Marrow derived Stem Cells(BMSC) transplanted intrathecally into patients with spinal cord injury. Receives: Other: Bone marrow derived stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as a measure of safety and tolerability.
The measure is the number of adverse events following intrathecal administration of autologous bone marrow derived stem cells in spinal cord injury patients.
Measured: 18 months
Secondary outcomes (1)
Significant improvement in the ASIA scores by the assessment motor, sensory and sphincteric function.
- Improvement in the functional Independence as measured by Spinal Cord Independence Measure (SCIM III). [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]
- Improvement in the pain sensation score as measured by Bryce/Ragnarsson SCI pain taxonomy (BR-SCI-PT). [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]
- Significant Changes in the muscle tone as indicated by Modified Ashworth Scale (MAS). [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]
- Improvement in the Clinical Outcome Variable Scale (COVS) score. [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]
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 posted21 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionNov 2014 (estimated)
- Study completionNov 2014 (estimated)
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 Spinal Cord InjuryStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Max Institute of Neurosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Yashbir Dewan, Max Institute of Neurosciences
- Investigators
- Yashbir Dewan, MS, MCh, Principal investigator, Max HealthcareYashbir Dewan, MS, MCh, Study chair, Max Helathcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01730183
- Sponsor's protocol ID
- TPSC/POC/BMSC/SCI
- Acronym
- ABSCI
- Status last verified
- Nov 2012
- First submitted
- 15 Nov 2012
- Last updated
- 21 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Geffner LF, Santacruz P, Izurieta M, Flor L, Maldonado B, Auad AH, Montenegro X, Gonzalez R, Silva F. Administration of autologous bone marrow stem cells into spinal cord injury patients via multiple routes is safe and improves their quality of life: comprehensive case studies. Cell Transplant. 2008;17(12):1277-93. doi: 10.3727/096368908787648074.
PubMed 19364066
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Study the Safety and Efficacy of Autologous Bone Marrow Stem Cells in Patients With Spinal Cord Injury (SCI)
- ClinicalTrials.gov ID
- NCT01730183
- Acronym / sponsor ID
- ABSCI / TPSC/POC/BMSC/SCI
- Conditions
- Spinal Cord Injury
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Max Institute of NeurosciencesIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 21 Nov 2012 (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 is a Phase I/II, multicenter, prospective, non-randomized, open label study to evaluate the safety/efficacy of autologous bone marrow-derived stem cell transplantation in spinal cord injury patients.
Detailed description
Spinal cord injury (SCI) is a traumatic disorder resulting in a functional deficit that usually leads to severe and permanent paralysis and the projected data related to the burden of spinal cord injuries across the globe is quite alarming. Pharmacological and rehabilitation therapies to SCI have got limited effect. There is definitely an urgent need for finding different methods of treatment for these patients who cannot undergo established modalities of treatment or these have been tried unsuccessfully. Another promising therapeutic approach for SCI is "Stem cell transplantation". Bone marrow derived stem cells have been shown to promote anatomical and functional recovery in animal models of SCI by promoting tissue sparing, axonal regeneration, and remyelination. In our present study, we want to evaluate the safety and efficacy of autologous bone marrow derived stem cells surgically transplanted intrathecally into patients with spinal cord injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bone marrow derived stem cells | Experimental | Other: Bone marrow derived stem cellsAutologous Bone Marrow derived Stem Cells(BMSC) transplanted intrathecally into patients with spinal cord injury. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Traumatic injury of the spinal cord (below C5 level) occurring within 6 months to 8 years prior to treatment, resulting in a sustained and complete / Partial loss of sensory and motor function below the injury (ASIA Category A, B and C ).
- Confirmation spinal cord injury level (Patients with complete or partial transection/damage by MRI).
- Those provide fully informed consent.
- The level of spinal cord injury must be below C4.
Key exclusion criteria (9 listed)
- Spinal vertebral instability.
- Major concurrent medical illness (e.g. carcinoma, auto-immune disease,)
- ASIA Impairment Scale category other than D \& E.
- Lactating and pregnant women.
- Syringomyelia is also an exclusion criterion but an exemption can be made for a patient with a stable syrinx.
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 |
|---|---|---|
| Bone marrow derived stem cellsAlso: Bone Marrow derived Mononucleated stem cell (BMMNCs)Intrathecal administration of autologous bone marrow derived stem cells upto a cell dose of equal or greater than 10(8)BMMNCs. | Other | Bone marrow derived stem cells |
Primary outcome
Number of participants with adverse events as a measure of safety and tolerability.
Time frame: 18 months
The measure is the number of adverse events following intrathecal administration of autologous bone marrow derived stem cells in spinal cord injury patients.
1 secondary outcome
Significant improvement in the ASIA scores by the assessment motor, sensory and sphincteric function.
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2012.
- Background: PubMed 19364066Geffner LF, Santacruz P, Izurieta M, Flor L, Maldonado B, Auad AH, Montenegro X, Gonzalez R, Silva F. Administration of autologous bone marrow stem cells into spinal cord injury patients via multiple routes is safe and improves their quality of life: comprehensive case studies. Cell Transplant. 2008;17(12):1277-93. doi: 10.3727/096368908787648074.
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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.
Yashbir Dewan, MS, MCh principal investigator
Max Healthcare
Yashbir Dewan, MS, MCh study chair
Max Helathcare
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 Bone marrow derived stem cells in people with Spinal Cord Injury, run by Max Institute of Neurosciences at 1 site in India.
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 9 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 21 Nov 2012. 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yashbir Dewan, MS, MCh (+91-8800255922, dr.ydewanneuro@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events as a measure of safety and tolerability. (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 NCT01730183, 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 21 Nov 2012.