Acute Spinal Cord InjuryPhase 1/2NCT02260713
Autologous Bone Marrow Cell Transplantation in Persons With Acute Spinal Cord Injury- An Indian Pilot Study.
A Phase 1/2 study testing autologous bone marrow cell in people with Acute Spinal Cord Injury, run by Indian Spinal Injuries Centre at 1 site in India.
Trial summary
Pilot study on 7 subjects in each group (total 21 subjects) to establish the safety and feasibility of autologous bone marrow cell transplantation in case of acute complete spinal cord injury by each of the following techniques and a corresponding number of controlled subjects: Directly into the injured site with a… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Acute Spinal Cord Injury
- What is being tested?
- autologous bone marrow cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2011to Nov 2017
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Acute spinal cord injury between 10 days and 14 days post injury.
- The subject must have a traumatic spinal cord injury between the spinal segmental levels T1 and T12 (Neurological Level).
- Must have a complete injury (ASIA-A).
Who cannot join
- Subject whose medical condition requires mechanical ventilation.
- Subjects with neurological level of injury above T1 and below T12.
- Subjects more than 14 days and less than 10 days post-injury.
- Lower motor neuron injury.
- Subjects with pathological fracture.
- Spinal Injuries in subjects with Ankylosing Spondylitis.
Show all 10Show fewer
- Subjects with extremes of age: less than 18 years or more than 50 years.
- Subjects with pre-existing severe medical disease which would affect the outcome like severe diabetes, rheumatoid arthritis.
- Subjects with Psychological disorders.
- Female subjects with pregnancy.
Trial locations and contacts
1 site in 1 country.
India1 site
Indian Spinal Injury Center
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: Autologous Bone Marrow Cell Transplantation in Persons With Acute Spinal Cord Injury- An Indian Pilot Study
Pilot study on 7 subjects in each group (total 21 subjects) to establish the safety and feasibility of autologous bone marrow cell transplantation in case of acute complete spinal cord injury by each of the following techniques and a corresponding number of controlled subjects:
- Directly into the injured site with a syringe after exposing the spinal cord.
- By Intrathecal injection.
Read the detailed description
Intervention : Autologous bone marrow cell: Transplantation of the autologous bone marrow cell transplantation through one of the below mentioned techniques: 1. Directly into the injured spinal cord site with a syringe after exposing the spinal cord. 2. By Intrathecal injection. Number of cells Injected: 200 million cells in 1.8 ml of autologous plasma. In case of Direct delivery, the cells were delivered in one sitting at six sites ( 2 above the lesion, 2 at the lesion and 2 below the lesion) as 0.3 ml aliquots each. In case of Intrathecal injection, the cells were delivered as a single injection of 1.8ml via lumbar puncture. Frequency of Injection: Single Total duration of Therapy: The procedure of Bone marrow harvesting, enrichment and transplantation was completed in a single setting of approximately 2-3 hours. The transplantation procedure in case of Direct delivery took 2 mins per injection site that is approximately 12 mins and in case of lumbar puncture the transplantation procedure took approximately 2 mins.
Comparator Agent:Control: control subjects with acute complete spinal cord injury who would not receive any bone marrow transplantation.
- Conditions
- Acute Spinal Cord Injury
- Being tested
- autologous bone marrow cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous bone marrow cellBiological
Transplantation of 200 million cells in 1.8 ml of autologous plasma in a single sitting. In case of intralesional route, the cells were delivered in one sitting at six sites ( 2 above the lesion, 2 at the lesion and 2 below the lesion) as 0.3 ml aliquots each. In case of Intrathecal route, the cells were delivered as a single injection of 1.8ml via lumbar puncture.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | control subjects with acute complete spinal cord injury who would not receive any bone marrow transplantation. |
| Transplantation via intrathecal route | Experimental | Subjects with acute complete spinal cord injury who receive autologous bone marrow cell transplantation via lumber puncture Receives: Biological: autologous bone marrow cell |
| Transplantation via intralesional route | Experimental | Subjects with acute complete spinal cord injury who receive autologous bone marrow cell transplantation via durotomy and injection at the lesional site . Receives: Biological: autologous bone marrow cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine for improvement in the ASIA classification.
Blinded assessors will examine for improvement in the ASIA classification of at least one grade by 12 months or change from baseline of 10 points or more in total motor score, with consideration of their distribution along the neuraxis, from the ASIA Impairment Scale (AIS) manual motor test by 12 months.
Measured: up to 5 years
Secondary outcomes (11)
Any voluntary movement by additional muscle groups not included in International Standards for Neurological Classification of Spinal Cord Injury
Measured: up to 5 years
Improvement by at least 1 point on the WISCI scale
Measured: up to 5 years
Decrease in spasticity by one grade or more as assessed by Modified Ashworth Spasticity Scale
Measured: up to 5 years
Improvement in ASIA sensory examination
Measured: up to 5 years
Improvements in SCIM score
Measured: up to 5 years
Psychological evaluation
Measured: up to 5 years
Improvements in EMG
Measured: up to 5 years
Improvements in SSEP
Measured: up to 5 years
Improvements in MEP
Measured: up to 5 years
Significant change in any of the variables included in urodynamic assessment
Measured: up to 5 years
Improvements in any of the variables included in ISCIS
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startFeb 2011
- Primary completionNov 2017
- Study completionNov 2017
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 Acute 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indian Spinal Injuries Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Indian Council of Medical Research
- Responsible party
- Sponsor
- Investigators
- Dr Harvinder S Chhabra, MS, Principal investigator, Indian Spinal Injuries Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02260713
- Sponsor's protocol ID
- ISIC-BMC
- Status last verified
- Feb 2016
- First submitted
- 16 Sep 2014
- Last updated
- 12 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chhabra HS, Sarda K, Arora M, Sharawat R, Singh V, Nanda A, Sangodimath GM, Tandon V. Autologous bone marrow cell transplantation in acute spinal cord injury--an Indian pilot study. Spinal Cord. 2016 Jan;54(1):57-64. doi: 10.1038/sc.2015.134. Epub 2015 Aug 18.
PubMed 26282492
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Bone Marrow Cell Transplantation in Persons With Acute Spinal Cord Injury- An Indian Pilot Study
- ClinicalTrials.gov ID
- NCT02260713
- Acronym / sponsor ID
- ISIC-BMC
- Conditions
- Acute Spinal Cord Injury
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Indian Spinal Injuries CentreUniversity, hospital or other
- Collaborators
- Indian Council of Medical Research
- Study start
- Feb 2011 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 9 Oct 2014 (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.
Pilot study on 7 subjects in each group (total 21 subjects) to establish the safety and feasibility of autologous bone marrow cell transplantation in case of acute complete spinal cord injury by each of the following techniques and a corresponding number of controlled subjects:
- Directly into the injured site with a syringe after exposing the spinal cord.
- By Intrathecal injection.
Detailed description
Intervention : Autologous bone marrow cell: Transplantation of the autologous bone marrow cell transplantation through one of the below mentioned techniques: 1. Directly into the injured spinal cord site with a syringe after exposing the spinal cord. 2. By Intrathecal injection. Number of cells Injected: 200 million cells in 1.8 ml of autologous plasma. In case of Direct delivery, the cells were delivered in one sitting at six sites ( 2 above the lesion, 2 at the lesion and 2 below the lesion) as 0.3 ml aliquots each. In case of Intrathecal injection, the cells were delivered as a single injection of 1.8ml via lumbar puncture. Frequency of Injection: Single Total duration of Therapy: The procedure of Bone marrow harvesting, enrichment and transplantation was completed in a single setting of approximately 2-3 hours. The transplantation procedure in case of Direct delivery took 2 mins per injection site that is approximately 12 mins and in case of lumbar puncture the transplantation procedure took approximately 2 mins.
Comparator Agent:Control: control subjects with acute complete spinal cord injury who would not receive any bone marrow transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –control subjects with acute complete spinal cord injury who would not receive any bone marrow transplantation. |
| Transplantation via intrathecal route | Experimental | Biological: autologous bone marrow cellSubjects with acute complete spinal cord injury who receive autologous bone marrow cell transplantation via lumber puncture |
| Transplantation via intralesional route | Experimental | Biological: autologous bone marrow cellSubjects with acute complete spinal cord injury who receive autologous bone marrow cell transplantation via durotomy and injection at the lesional site . |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Acute spinal cord injury between 10 days and 14 days post injury.
- The subject must have a traumatic spinal cord injury between the spinal segmental levels T1 and T12 (Neurological Level).
- Must have a complete injury (ASIA-A).
Key exclusion criteria (10 listed)
- Subject whose medical condition requires mechanical ventilation.
- Subjects with neurological level of injury above T1 and below T12.
- Subjects more than 14 days and less than 10 days post-injury.
- Lower motor neuron injury.
- Subjects with pathological fracture.
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 cellTransplantation of 200 million cells in 1.8 ml of autologous plasma in a single sitting. In case of intralesional route, the cells were delivered in one sitting at six sites ( 2 above the lesion, 2 at the lesion and 2 below the lesion) as 0.3 ml aliquots each. In case of Intrathecal route, the cells were delivered as a single injection of 1.8ml via lumbar puncture. | Biological | Transplantation via intralesional route, Transplantation via intrathecal route |
Primary outcome
Examine for improvement in the ASIA classification.
Time frame: up to 5 years
Blinded assessors will examine for improvement in the ASIA classification of at least one grade by 12 months or change from baseline of 10 points or more in total motor score, with consideration of their distribution along the neuraxis, from the ASIA Impairment Scale (AIS) manual motor test by 12 months.
11 secondary outcomes
Any voluntary movement by additional muscle groups not included in International Standards for Neurological Classification of Spinal Cord Injury
Time frame: up to 5 years
Improvement by at least 1 point on the WISCI scale
Time frame: up to 5 years
Decrease in spasticity by one grade or more as assessed by Modified Ashworth Spasticity Scale
Time frame: up to 5 years
Improvement in ASIA sensory examination
Time frame: up to 5 years
Improvements in SCIM score
Time frame: up to 5 years
Psychological evaluation
Time frame: up to 5 years
Improvements in EMG
Time frame: up to 5 years
Improvements in SSEP
Time frame: up to 5 years
Improvements in MEP
Time frame: up to 5 years
Significant change in any of the variables included in urodynamic assessment
Time frame: up to 5 years
Improvements in any of the variables included in ISCIS
Time frame: up to 5 years
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 12 Mar 2018.
- Results publication: PubMed 26282492Chhabra HS, Sarda K, Arora M, Sharawat R, Singh V, Nanda A, Sangodimath GM, Tandon V. Autologous bone marrow cell transplantation in acute spinal cord injury--an Indian pilot study. Spinal Cord. 2016 Jan;54(1):57-64. doi: 10.1038/sc.2015.134. Epub 2015 Aug 18.
- Individual participant dataSharing planned: No
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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 Harvinder S Chhabra, MS principal investigator
Indian Spinal Injuries Centre
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 cell in people with Acute Spinal Cord Injury, run by Indian Spinal Injuries Centre 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 3 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: finished, as of the sponsor's last update on 12 Mar 2018. 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?
Examine for improvement in the ASIA classification. (time frame: up to 5 years). 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 NCT02260713, 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 12 Mar 2018.