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

Primary Purpose

Acute Stroke

Status

Completed

Phase

Phase 2

Locations

India

Study Type

Interventional

Intervention

Autologous bone marrow stem cell

About this trial

This is an interventional treatment trial for Acute Stroke focused on measuring Acute ischemic stroke

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.)

Exclusion Criteria: -

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.
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.

Sites / Locations

All India Institute of Medical Sciences
Army Hospital (R & R Hospital)
Post Graduate Institute of Medical Education and Research
Armed Forces Medical College
Sanjay Gandhi Postgraduate Institute of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Autologous bone marrow stem cell

Control

Arm Description

Outcomes

Primary Outcome Measures

Barthel index score

The primary efficacy outcome is difference between the two groups in the modified Barthel index score at six month post randomization.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01501773

First Posted

December 26, 2011

Last Updated

December 26, 2011

Sponsor

Manipal Acunova Ltd.

Collaborators

Ministry of Science and Technology, India

1. Study Identification

Unique Protocol Identification Number

NCT01501773

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Manipal Acunova Ltd.

Collaborators

Ministry of Science and Technology, India

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Stroke

Keywords

Acute ischemic stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Autologous bone marrow stem cell

Arm Type

Experimental

Arm Title

Control

Arm Type

No Intervention

Intervention Type

Biological

Intervention Name(s)

Autologous bone marrow stem cell

Intervention Description

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

Primary Outcome Measure Information:

Title

Barthel index score

Description

The primary efficacy outcome is difference between the two groups in the modified Barthel index score at six month post randomization.

Time Frame

six month post randomization

Secondary Outcome Measure Information:

Title

NIHSS score and functional status

Description

Time Frame

3, 6 and 12 months post randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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.) Exclusion Criteria: - 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. 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.

Overall Study Officials: