Acute StrokePhase 2NCT01501773
Intravenous Autologous Bone Marrow-derived Stem Cells Therapy for Patients With Acute Ischemic Stroke
A Phase 2 study testing Autologous bone marrow stem cell in people with Acute Stroke, run by Manipal Acunova Ltd. at 5 sites in India.
Trial summary
A multi-centric initiative to study safety,feasibility and efficacy of using intravenous autologous bone marrow mononuclear cells(BMMC) in patients with acute ischemic stroke.This phase of study is visualised as phase 2 study and will aim to determine dose response gradient of stem cell therapy and to explore if there… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Stroke
- What is being tested?
- Autologous bone marrow stem cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 5 sitesIndia
- Study dates
- Oct 2008to Oct 2011
- Phase
- Phase 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sudden onset of focal neurologic deficit or impairment of consciousness.
- CT or MRI scan of head showing no haematoma and relevant lesions within the MCA and ACA territory.
- Age between 30 -70 years (after amendment 18 -70 years).
- >7 to </=30 days passed since the onset of the qualifying event.
- Glasgow Coma Scale score of >8 at the time of randomization, in aphasic Eye and Motor score of >6.
- Modified Barthel Index score of 50 or less at the time of randomization.
- NHISS score of 7 or more points and inability to walk unaided or raise upper limb by 90 degree.
- Patient is stable. ( normal respiration, afebrile, BP less than mean arterial pressure of 125 mm of Hg, fasting blood sugar < 200 mg% and normal urea/electrolytes for at least 48 hours.)
Who cannot join
- Lacunar syndrome
- Intubation
- Posterior circulation stroke
- Co morbidity likely to limit survival to less than 3 years eg. Hepatic or renal failure.
- Inaccessibility for follow up.
- Allergy to local anaesthetic.
Show all 9Show fewer
- Unwillingness to provide written informed consent.
- Symptom of acute myocardial infarction or acute involvement of any other organ.
- Pregnancy 10. HIV positive 11. Patient is a part of any other trial in last 6 months.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
India5 sites
Post Graduate Institute of Medical Education and Research
Chandīgarh, Haryana, 160012
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, 226014
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
Army Hospital (R & R Hospital)
New Delhi, National Capital Territory of Delhi
Armed Forces Medical College
Pune, Maharashtra, 411040
About this study
Official title: Phase II Intravenous Autologous Bone Marrow-derived Stem Cells Therapy for Patients With Acute Ischemic Stroke
A multi-centric initiative to study safety,feasibility and efficacy of using intravenous autologous bone marrow mononuclear cells(BMMC) in patients with acute ischemic stroke.This phase of study is visualised as phase 2 study and will aim to determine dose response gradient of stem cell therapy and to explore if there is favorable risk to benefit ratio for autologous stem cell therapy in patient with acute ischamic stroke.
Read the detailed description
This phase of the study will have two arms developed through random allocation: one arm for intravenous autologous bone marrow derived stem cell/mononuclear cells(BMMC arm); and second control arm. Patients with acute ischaemic stroke between 7-30 days after onset with moderae severity in sable condition will be entered into the study after informed consent. Both arms will receive standard treatment but BMMC arm will,in addition,have bone marrow aspiration and receive autologous 30-500 million bone marrow mononuclear cells intravenously on the day of randomisation and all patients will be followed at DaY 7 ± days, Day 90(-7 days to +14 days), Day 180(-7 days to +28 days)and Day 365 (-7 days to + 28 days). A number of safety and efficacy variables will be measured. This phase 2 study will aim to determine dose response gradient of stem cell therapy and to explore if results have a favourable risk to benefit ratio to justify a phase 3 study. This will be the first human trial to determine and compare favourable and unfavourable effects of bone marrow mononuclear cells(mainly CD34) in acute ischamic stroke and also the first multi-centric study with potential to achieve a reasonable sample size in a relatively short time.
- Conditions
- Acute Stroke
- Being tested
- Autologous bone marrow stem cell
- Keywords
- Acute ischemic stroke
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous bone marrow stem cellBiological
Autologous bone marrow stem cell have bone marrow aspiration and receive 30-500 million bone marrow mononuclear cells intravenously on the day of randomization.
| Study group | Role | What they receive |
|---|---|---|
| Autologous bone marrow stem cell | Experimental | Not described Receives: Biological: Autologous bone marrow stem cell |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barthel index score
The primary efficacy outcome is difference between the two groups in the modified Barthel index score at six month post randomization.
Measured: six month post randomization
Secondary outcomes (1)
NIHSS score and functional status
- NIHSS score at 6 months and one year post randomization.
- And degree of handicap as measured by Modified Ranking scale administered at 3, 6 and 12 months post randomization and functional status at 6 months and 12 months post randomization
Measured: 3, 6 and 12 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startOct 2008
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute StrokeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manipal Acunova Ltd.
- Sponsor type
- Research network
- Collaborators
- Ministry of Science and Technology, India
- Responsible party
- Sponsor
- Investigators
- Dr. Kameshwar Prasad, MBBS, MD, Principal investigator, All India Institute of Medical SciencesDr. Usha Kant Misra, MBBS, MD, DM, Principal investigator, Sanjay Gandhi Postgraduate Institute of Medical SciencesDr. R.S Sarkar, Principal investigator, Armed Forces Medical CollegeDr. Sudesh Kumar Prabhakar, MBBS, MD, DM, Principal investigator, Post Graduate Institute of Medical Education and Research, ChandigarhDr. Sharat Joshi, MBBS,MD, DM, Principal investigator, Army R & R Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501773
- Sponsor's protocol ID
- INVEST
- Status last verified
- Dec 2011
- First submitted
- 26 Dec 2011
- Last updated
- 29 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Prasad K, Sharma A, Garg A, Mohanty S, Bhatnagar S, Johri S, Singh KK, Nair V, Sarkar RS, Gorthi SP, Hassan KM, Prabhakar S, Marwaha N, Khandelwal N, Misra UK, Kalita J, Nityanand S; InveST Study Group. Intravenous autologous bone marrow mononuclear stem cell therapy for ischemic stroke: a multicentric, randomized trial. Stroke. 2014 Dec;45(12):3618-24. doi: 10.1161/STROKEAHA.114.007028. Epub 2014 Nov 6.
PubMed 25378424Prasad K, Mohanty S, Bhatia R, Srivastava MV, Garg A, Srivastava A, Goyal V, Tripathi M, Kumar A, Bal C, Vij A, Mishra NK. Autologous intravenous bone marrow mononuclear cell therapy for patients with subacute ischaemic stroke: a pilot study. Indian J Med Res. 2012 Aug;136(2):221-8.
PubMed 22960888
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Intravenous Autologous Bone Marrow-derived Stem Cells Therapy for Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT01501773
- Acronym / sponsor ID
- INVEST
- Conditions
- Acute Stroke
- Keywords
- Acute ischemic stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Manipal Acunova Ltd.Research network
- Collaborators
- Ministry of Science and Technology, India
- Study start
- Oct 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 29 Dec 2011 (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.
A multi-centric initiative to study safety,feasibility and efficacy of using intravenous autologous bone marrow mononuclear cells(BMMC) in patients with acute ischemic stroke.This phase of study is visualised as phase 2 study and will aim to determine dose response gradient of stem cell therapy and to explore if there is favorable risk to benefit ratio for autologous stem cell therapy in patient with acute ischamic stroke.
Detailed description
This phase of the study will have two arms developed through random allocation: one arm for intravenous autologous bone marrow derived stem cell/mononuclear cells(BMMC arm); and second control arm. Patients with acute ischaemic stroke between 7-30 days after onset with moderae severity in sable condition will be entered into the study after informed consent. Both arms will receive standard treatment but BMMC arm will,in addition,have bone marrow aspiration and receive autologous 30-500 million bone marrow mononuclear cells intravenously on the day of randomisation and all patients will be followed at DaY 7 ± days, Day 90(-7 days to +14 days), Day 180(-7 days to +28 days)and Day 365 (-7 days to + 28 days). A number of safety and efficacy variables will be measured. This phase 2 study will aim to determine dose response gradient of stem cell therapy and to explore if results have a favourable risk to benefit ratio to justify a phase 3 study. This will be the first human trial to determine and compare favourable and unfavourable effects of bone marrow mononuclear cells(mainly CD34) in acute ischamic stroke and also the first multi-centric study with potential to achieve a reasonable sample size in a relatively short time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous bone marrow stem cell | Experimental | Biological: Autologous bone marrow stem cell |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Sudden onset of focal neurologic deficit or impairment of consciousness.
- CT or MRI scan of head showing no haematoma and relevant lesions within the MCA and ACA territory.
- Age between 30 -70 years (after amendment 18 -70 years).
- >7 to </=30 days passed since the onset of the qualifying event.
- Glasgow Coma Scale score of >8 at the time of randomization, in aphasic Eye and Motor score of >6.
Key exclusion criteria (9 listed)
- Lacunar syndrome
- Intubation
- Posterior circulation stroke
- Co morbidity likely to limit survival to less than 3 years eg. Hepatic or renal failure.
- Inaccessibility for follow up.
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 stem cellAutologous bone marrow stem cell have bone marrow aspiration and receive 30-500 million bone marrow mononuclear cells intravenously on the day of randomization. | Biological | Autologous bone marrow stem cell |
Primary outcome
Barthel index score
Time frame: six month post randomization
The primary efficacy outcome is difference between the two groups in the modified Barthel index score at six month post randomization.
1 secondary outcome
NIHSS score and functional status
Time frame: 3, 6 and 12 months post randomization
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 29 Dec 2011.
- Derived from this study: PubMed 25378424Prasad K, Sharma A, Garg A, Mohanty S, Bhatnagar S, Johri S, Singh KK, Nair V, Sarkar RS, Gorthi SP, Hassan KM, Prabhakar S, Marwaha N, Khandelwal N, Misra UK, Kalita J, Nityanand S; InveST Study Group. Intravenous autologous bone marrow mononuclear stem cell therapy for ischemic stroke: a multicentric, randomized trial. Stroke. 2014 Dec;45(12):3618-24. doi: 10.1161/STROKEAHA.114.007028. Epub 2014 Nov 6.
- Derived from this study: PubMed 22960888Prasad K, Mohanty S, Bhatia R, Srivastava MV, Garg A, Srivastava A, Goyal V, Tripathi M, Kumar A, Bal C, Vij A, Mishra NK. Autologous intravenous bone marrow mononuclear cell therapy for patients with subacute ischaemic stroke: a pilot study. Indian J Med Res. 2012 Aug;136(2):221-8.
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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. Kameshwar Prasad, MBBS, MD principal investigator
All India Institute of Medical Sciences
Dr. Usha Kant Misra, MBBS, MD, DM principal investigator
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Dr. R.S Sarkar principal investigator
Armed Forces Medical College
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Autologous bone marrow stem cell in people with Acute Stroke, run by Manipal Acunova Ltd. at 5 sites 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 8 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: finished, as of the sponsor's last update on 29 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 phase mean?
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?
Barthel index score (time frame: six month post randomization). 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 NCT01501773, which also lists 2 linked publications.
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 29 Dec 2011.