Spinal Cord InjuriesPhase 1/2ABMST-SCINCT01186679
Safety and Efficacy of Autologous Bone Marrow Stem Cells in Treating Spinal Cord Injury
A Phase 1/2 study testing laminectomy and Intrathecal in people with Spinal Cord Injuries, run by International Stemcell Services Limited at 1 site in India.
Trial summary
The projected data related to the burden of spinal cord injuries induced limb paralysis in India is quite alarming. This is attributed to the rapid industrialization and economical development in the country. Increase in vehicular traffic has caused numerous road traffic accidents. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- laminectomy and Intrathecal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2008to Aug 2010
- 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Must be able to give voluntary (patients may not be able to write) consent.
- Must be able to understand study information provided to him.
- Patients with complete spinal cord trans-section: at least post 6 months after spinal cord Injury (in chronic patients), < 2 weeks in acute category and 2-8 weeks in subacute patients.
- The level of spinal cord injury must be between C4 and T12(neurological level)
- Spinal cord injury categorized in terms of ASIA Impairment scale.
- Age should be between 20-55 years
Who cannot join
- Mechanical ventilation due to neurological impairment
- Multiple level trauma
- Undetermined size and location of Spinal Cord injury
- Gunshot or other penetrating trauma to the spinal cord
- Longitudinal dimension of injury by MRI is greater than 3spinal segments
- Associated severe head injury
Show all 12Show fewer
- More than 9cms long bone fracture
- Women who are pregnant or lactating
- Serious pre-existing medical conditions
- Disease or impairment that precludes adequate neurological examination.
- Should not have co-morbidities like Diabetes, Systemic Hypertension etc.
- Severe co-morbidities/bed sores Tests positive for infectious diseases Deranged Coagulation profile and Hb < 8mg/dl
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Transplantation of Autologous Bone Marrow Stem Cells With Glial Scar Resection for Patients of Chronic Spinal Cord Injury and Intra-thecal Injection for Acute and Subacute Injury - A Preliminary Study
The projected data related to the burden of spinal cord injuries induced limb paralysis in India is quite alarming. This is attributed to the rapid industrialization and economical development in the country. Increase in vehicular traffic has caused numerous road traffic accidents. Rapid increase in populations, development in the computer technology and real estate business lead to construction of huge buildings which indirectly adds to the injuries due to fall. Spinal cord injuries could not be treated adequately with the prevailing treatment modalities. In view of this, 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. Since a large number of these patients will loose their productive life and at the prime of their lives, one such alternate therapy, which seems to offer some promise, is "stem cell" therapy, which has been well studied and published in prestigious journals.
In our present study, we want to evaluate the safety and efficacy of autologous bone marrow derived stem cells surgically transplanted directly into the lesion site with glial scar resection for 8 indian patients of chronic spinal cord injury and intra-thecal injection for 4 indian patients of acute and subacute injury.
- Conditions
- Spinal Cord Injuries
- Being tested
- laminectomy, Intrathecal
- 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.
laminectomyProcedure or surgery
surgical laminectomy with glial scar resection
IntrathecalProcedure or surgery
direct into the CSF through lumbar puncture
| Study group | Role | What they receive |
|---|---|---|
| Intralesional | Experimental | 1. Surgical transplantation into the lesion site in chronic patients
2. Direct intrathecal implantation in acute and subacute patients Receives: Procedure: laminectomy |
| intrathecal | Experimental | direct into the CSF through lumbar puncture Receives: Procedure: Intrathecal |
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. Significant clinical improvement in ASIA impairment scale and general condition
American Spinal Injury Assessment scale of A,B,C,D or E
Measured: 18 months
Secondary outcomes (1)
Changes in the MRI, Neurological improvement (cranial/spinal reflexes) and evoked potentials study
MRI findings of the lesion, Nerve conduction studies of the region and somatosensory evoked potentials of the same region
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 posted23 Aug 2010 (estimated)
- Study startJan 2008
- Primary completionFeb 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Stemcell Services Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dr.Arvind Bhateja, MCh.Neurosurgery, Principal investigator, Sita Bhateja Speciality Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186679
- Sponsor's protocol ID
- ISSL-AuBM-SCI
- Acronym
- ABMST-SCI
- Status last verified
- Aug 2010
- First submitted
- 20 Aug 2010
- Last updated
- 23 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Transplantation of Autologous Bone Marrow Stem Cells With Glial Scar Resection for Patients of Chronic Spinal Cord Injury and Intra-thecal Injection for Acute and Subacute Injury - A Preliminary Study
- ClinicalTrials.gov ID
- NCT01186679
- Acronym / sponsor ID
- ABMST-SCI / ISSL-AuBM-SCI
- Conditions
- Spinal Cord Injuries
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- International Stemcell Services LimitedIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 23 Aug 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 projected data related to the burden of spinal cord injuries induced limb paralysis in India is quite alarming. This is attributed to the rapid industrialization and economical development in the country. Increase in vehicular traffic has caused numerous road traffic accidents. Rapid increase in populations, development in the computer technology and real estate business lead to construction of huge buildings which indirectly adds to the injuries due to fall. Spinal cord injuries could not be treated adequately with the prevailing treatment modalities. In view of this, 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. Since a large number of these patients will loose their productive life and at the prime of their lives, one such alternate therapy, which seems to offer some promise, is "stem cell" therapy, which has been well studied and published in prestigious journals.
In our present study, we want to evaluate the safety and efficacy of autologous bone marrow derived stem cells surgically transplanted directly into the lesion site with glial scar resection for 8 indian patients of chronic spinal cord injury and intra-thecal injection for 4 indian patients of acute and subacute injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intralesional | Experimental | Procedure: laminectomy1. Surgical transplantation into the lesion site in chronic patients 2. Direct intrathecal implantation in acute and subacute patients |
| intrathecal | Experimental | Procedure: Intrathecaldirect into the CSF through lumbar puncture |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Must be able to give voluntary (patients may not be able to write) consent.
- Must be able to understand study information provided to him.
- Patients with complete spinal cord trans-section: at least post 6 months after spinal cord Injury (in chronic patients), < 2 weeks in acute category and 2-8 weeks in subacute patients.
- The level of spinal cord injury must be between C4 and T12(neurological level)
- Spinal cord injury categorized in terms of ASIA Impairment scale.
Key exclusion criteria (12 listed)
- Mechanical ventilation due to neurological impairment
- Multiple level trauma
- Undetermined size and location of Spinal Cord injury
- Gunshot or other penetrating trauma to the spinal cord
- Longitudinal dimension of injury by MRI is greater than 3spinal segments
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 |
|---|---|---|
| laminectomysurgical laminectomy with glial scar resection | Procedure or surgery | Intralesional |
| Intrathecaldirect into the CSF through lumbar puncture | Procedure or surgery | intrathecal |
Primary outcome
Number of Participants with adverse events as a measure of safety and tolerability. Significant clinical improvement in ASIA impairment scale and general condition
Time frame: 18 months
American Spinal Injury Assessment scale of A,B,C,D or E
1 secondary outcome
Changes in the MRI, Neurological improvement (cranial/spinal reflexes) and evoked potentials study
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 23 Aug 2010.
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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.
Dr.Arvind Bhateja, MCh.Neurosurgery principal investigator
Sita Bhateja Speciality Hospital
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 laminectomy and Intrathecal in people with Spinal Cord Injuries, run by International Stemcell Services Limited 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 6 inclusion and 12 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 23 Aug 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 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?
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?
Number of Participants with adverse events as a measure of safety and tolerability. Significant clinical improvement in ASIA impairment scale and general condition (time frame: 18 months). It is what the study was designed to measure, not a finding.
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 23 Aug 2010.