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Intravenous Autologous Bone Marrow-derived Stem Cells Therapy for Patients With Acute Ischemic Stroke

NCT ID: NCT01501773

Last Updated: 2011-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-10-31

Brief Summary

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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

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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

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Acute Stroke

Keywords

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Acute ischemic stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Autologous bone marrow stem cell

Group Type EXPERIMENTAL

Autologous bone marrow stem cell

Intervention Type BIOLOGICAL

Autologous bone marrow stem cell have bone marrow aspiration and receive 30-500 million bone marrow mononuclear cells intravenously on the day of randomization.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Autologous bone marrow stem cell

Autologous bone marrow stem cell have bone marrow aspiration and receive 30-500 million bone marrow mononuclear cells intravenously on the day of randomization.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Sudden onset of focal neurologic deficit or impairment of consciousness.
2. CT or MRI scan of head showing no haematoma and relevant lesions within the MCA and ACA territory.
3. Age between 30 -70 years (after amendment 18 -70 years).
4. \>7 to \</=30 days passed since the onset of the qualifying event.
5. Glasgow Coma Scale score of \>8 at the time of randomization, in aphasic Eye and Motor score of \>6.
6. Modified Barthel Index score of 50 or less at the time of randomization.
7. NHISS score of 7 or more points and inability to walk unaided or raise upper limb by 90 degree.
8. 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.)

Exclusion Criteria

1. Lacunar syndrome
2. Intubation
3. Posterior circulation stroke
4. Co morbidity likely to limit survival to less than 3 years eg. Hepatic or renal failure.
5. Inaccessibility for follow up.
6. Allergy to local anaesthetic.
7. Unwillingness to provide written informed consent.
8. Symptom of acute myocardial infarction or acute involvement of any other organ.
9. Pregnancy 10. HIV positive 11. Patient is a part of any other trial in last 6 months.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Science and Technology, India

OTHER_GOV

Sponsor Role collaborator

Manipal Acunova Ltd.

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr. Kameshwar Prasad, MBBS, MD

Role: PRINCIPAL_INVESTIGATOR

All India Institute of Medical Sciences

Dr. Usha Kant Misra, MBBS, MD, DM

Role: PRINCIPAL_INVESTIGATOR

Sanjay Gandhi Postgraduate Institute of Medical Sciences

Dr. R.S Sarkar

Role: PRINCIPAL_INVESTIGATOR

Armed Forces Medical College

Dr. Sudesh Kumar Prabhakar, MBBS, MD, DM

Role: PRINCIPAL_INVESTIGATOR

Post Graduate Institute of Medical Education and Research, Chandigarh

Dr. Sharat Joshi, MBBS,MD, DM

Role: PRINCIPAL_INVESTIGATOR

Army R & R Hospital

Locations

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Post Graduate Institute of Medical Education and Research

Chandīgarh, Haryana, India

Site Status

Armed Forces Medical College

Pune, Maharashtra, India

Site Status

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status

Army Hospital (R & R Hospital)

New Delhi, National Capital Territory of Delhi, India

Site Status

Sanjay Gandhi Postgraduate Institute of Medical Sciences

Lucknow, Uttar Pradesh, India

Site Status

Countries

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India

References

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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.

Reference Type DERIVED
PMID: 25378424 (View on PubMed)

Prasad 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.

Reference Type DERIVED
PMID: 22960888 (View on PubMed)

Other Identifiers

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INVEST

Identifier Type: -

Identifier Source: org_study_id