AzTrials
AzTrials

Middle Cerebral Artery InfarctionPhase 2InVeSTNCT02425670

Stem Cell Therapy For Acute Ischemic Stroke Patients

A Phase 2 study testing BMSCs in people with Middle Cerebral Artery Infarction and Anterior Cerebral Artery Infarction, run by All India Institute of Medical Sciences at 5 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
BMSCs
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
Jan 2009to Jun 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,
Show all 9Show fewer
  • 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.

Who cannot join

  • Patients meeting the inclusion criteria will be considered ineligible for the study if they have any one of the following:
  • 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,
Show all 13Show fewer
  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

India5 sites

  • Postgraduate Institute of Medical Education & Research

    Chandigarh, Chandigarh, 160 012

  • Army Hospital (Referral and Research Centre),

    Delhi Cantonment, National Capital Territory of Delhi, 110010

  • 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

  • Armed Forces Medical College

    Pune, Maharashtra, 411040

Other trials in India

About this study

Official title: Intravenous Autologous Bone Marrow-derived Stem Cells Therapy for Patients With Acute Ischemic Stroke: A Multi-Institutional Project

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.

Read the detailed description

Background: Stroke accounts for significant disability and there is need for novel treatment modality which can improve the functional outcome. In this randomized clinical trial, investigators proposed to examine stem cell therapy as a potential therapeutic modality. Stem cells in animal stroke models have shown reduction in infarct size and improvement in neurological function. Only one human clinical trial with intravenous autologous marrow stromal cell therapy of five patients has shown some benefit. The primary objective of this phase II study was to explore if there is favourable risk to benefit ratio for autologous bone marrow derived mononuclear stem cell therapy (BMSCs) in patients with acute ischemic stroke to justify a larger phase III trial.

Methods \& Design: The study recruited 120 men and women aged 18-70 years presenting with acute ischemic stroke (7-29 days) and a NIHSS score of ≥ 7 and BI ≤ 50. Following baseline assessment (MRI Brain, Whole Body PET scan, EEG brain, CT scan Brain and clinical examination including National Institute of Health Stroke Scale (NIHSS), Barthel Index (BI), modified Rankin Scale (mRS), Glasgow Come Scale (GCS), participants were randomly allocated to two groups: conventional management alone (control group); or conventional management and autologous intravenous BMSCs transplantation (experimental group). Bone marrow was aspirated under local anaesthesia and the isolated BMSCs cells injected intravenously within 4 hours. The patients were monitored with hemogram \& renal/liver function tests, CT scan brain at 36 hrs and clinical examination for a week. The patients were followed up to one year with periodic MRI brain at 3 months, 6 months, EEG \& PET scan at 6 months and 1 year. The primary efficacy outcomes were difference between the two groups in the Modified Barthel index score and modified Rankin Scale score at six-month post-randomisation. The secondary efficacy outcomes are: NIHSS score at six-months and 1 year post-randomisation; and the modified Rankin scale score at 3 months and one year post-randomization, and functional status measured by barthel index (in binary scale <60 or >60 ) at six months and one year post-randomization. Dose response analysis were done by comparing outcomes in patients receiving various doses of bone marrow mononuclear cells.

Discussion: This phase 2 study was aimed to explore if there is a favourable risk-to-benefit ratio for stem cell therapy in patients with acute ischemic stroke. Investigators also planned to examine whether there is justification for phase III trial of autologous bone marrow derived mononuclear stem cell therapy for acute ischemic stroke.

Being tested
BMSCs
Keywords
Brain attack, stroke, Ischemic stroke, stem cell therapy
Medical subject headings
Infarction, Middle Cerebral Artery, Infarction, Anterior Cerebral Artery, Stroke, Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMSCsOther

    Also called Stem cell arm

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

Study groups in NCT02425670
Study groupRoleWhat they receive
Bone marrow derived stem cells (BMSCs)ExperimentalBMSCs 30-500 million plus conventional management
Receives: Other: BMSCs
ControlNo interventionControl: conventional management

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 months

Secondary outcomes (3)

  1. Neurological deficit on NIHSS score

    Measured: 6 months and 1 year

  2. Measurement of disability on Modified Rankin Scale

    Measured: 3 months, 6 months and one year

  3. 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)

    Measured: 6 months and one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2015 (estimated)
  2. Study startJan 2009
  3. Primary completionOct 2010
  4. Study completionJun 2011

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02425670
Sponsor's protocol ID
BT/pr6815/MED/14/880/2005AIIMS
Other IDs
REFCTRI000046, 19.04.2008
Acronym
InVeST
Status last verified
Apr 2015
First submitted
7 Apr 2015
Last updated
24 Apr 2015
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 25378424

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BMSCs in people with Middle Cerebral Artery Infarction and Anterior Cerebral Artery Infarction, run by All India Institute of Medical Sciences 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 9 inclusion and 13 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 24 Apr 2015. 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?

Functional ability to perform activities of daily living on Modified Barthel Index Score (time frame: 6 months). 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 NCT02425670, 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 24 Apr 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in