NCT02425670

Brief Summary

The purpose of this study is to determine whether patients with subacute ischemic stroke will benefit from infusion of patient's own bone marrow derived stem cells. Primary Hypothesis: Intravenous injection of bone marrow mononuclear cells at a dose of 30 to 500 million in patients with subacute ischemic stroke results in reduction of infarct volume and improvement of neurological function compared to those without the injection. Secondary Hypothesis: Patients receiving more than 100 million Bone marrow derived stem cells (BMSC) will have better outcome than those receiving fewer dosages of cells.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 24, 2015

Completed
Last Updated

April 24, 2015

Status Verified

April 1, 2015

Enrollment Period

1.7 years

First QC Date

April 7, 2015

Last Update Submit

April 21, 2015

Conditions

Middle Cerebral Artery InfarctionAnterior Cerebral Artery Infarction

Keywords

Brain attackstrokeIschemic strokestem cell therapy

Outcome Measures

Primary Outcomes (1)

  • Functional ability to perform activities of daily living on Modified Barthel Index Score

    6 months

Secondary Outcomes (3)

  • Neurological deficit on NIHSS score

    6 months and 1 year

  • Measurement of disability on Modified Rankin Scale

    3 months, 6 months and one year

  • Functional ability to perform activities of daily living on Modified Barthel Index (Functional status) on binary scale as independent (Barthel index > 60) or dead or dependent (Barthel Index <60)

    6 months and one year

Study Arms (2)

Bone marrow derived stem cells (BMSCs)

EXPERIMENTAL

BMSCs 30-500 million plus conventional management

Other: BMSCs

Control

NO INTERVENTION

Control: conventional management

Interventions

BMSCsOTHER

30-500 million Autologous BMSCs will be given intravenously to patients with acute ischemic stroke (onset from 7 to less than 30 days).

Also known as: Stem cell arm
Bone marrow derived stem cells (BMSCs)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients will be judged eligible if they have all of the following:
  • Sudden onset of focal neurologic deficit or impairment of consciousness,
  • Computerized tomographic or MRI scan of the head showing no primary haematoma, and relevant lesions within the Middle Cerebral Artery (MCA) and anterior cerebral artery (ACA) territory. Hemorrhagic changes in infarct are acceptable.
  • Age between 18 and 75 years
  • Seven days or more but less than 30 days since the onset of the qualifying event,
  • Glasgow Coma Scale score of above 8 at the time of randomization, in aphasic Eye and Motor score of more than 6,
  • Modified Barthel index score of 50 or less at the time of randomization.
  • NIHSS score of 7 or more points and inability to walk unaided or raise upper limb by 90 °
  • Patient is stable: A patient will be defined as stable when he has normal respiration, is afebrile, has BP less than mean arterial pressure of 125mm Hg (but no hypotension defined as systolic BP \<90mmHg), has fasting venous blood sugar level less than 200mg % and normal urea/electrolytes for at least 48 hours.

You may not qualify if:

  • Lacunar syndrome
  • Intubation
  • Posterior Circulation Stroke
  • Co-morbidity likely to limit survival to less than three years e.g. malignant diseases, hepatic or renal failure
  • Pre-stroke disability leading to dependence on others for activities of daily living,
  • Inaccessibility for follow-up
  • Allergy to local anaesthetic
  • Unwillingness to provide written informed consent by self or assent by next of kin.
  • Symptom of Acute myocardial infarction or acute involvement of any other organ.
  • Pregnancy
  • Human immunodeficiency virus (HIV)/hepatitis C virus (HCV)/HbsAg positive.
  • Patient is a part of any other trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Postgraduate Institute of Medical Education & Research

Chandigarh, Chandigarh, 160 012, India

Location

Armed Forces Medical College

Pune, Maharashtra, 411040, India

Location

Army Hospital (Referral and Research Centre),

Delhi Cantonment, National Capital Territory of Delhi, 110010, India

Location

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Sanjay Gandhi Postgraduate Institute of Medical Sciences

Lucknow, Uttar Pradesh, 226014, India

Location

Related Publications (1)

  • 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.

    PMID: 25378424RESULT

Related Links

MeSH Terms

Conditions

Infarction, Middle Cerebral ArteryInfarction, Anterior Cerebral ArteryStrokeIschemic Stroke

Condition Hierarchy (Ancestors)

Cerebral InfarctionBrain InfarctionBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCerebral Arterial DiseasesIntracranial Arterial DiseasesVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Kameshwar Prasad, MBBS, MD

    All India Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Head, Department of Neurology

Study Record Dates

First Submitted

April 7, 2015

First Posted

April 24, 2015

Study Start

January 1, 2009

Primary Completion

October 1, 2010

Study Completion

June 1, 2011

Last Updated

April 24, 2015

Record last verified: 2015-04

Locations

IN(5)