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

Phase 2

Completed

• Conditions: Acute Stroke
• Interventions: Biological: Autologous bone marrow stem cell

• Registration Number: NCT01501773
• Lead Sponsor: Manipal Acunova Ltd.

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.

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2011-12
• Study First Submitted: 2011-12-26
• Study First Submitted QC: 2011-12-26
• Last Update Submitted: 2011-12-26
• Study First Posted: 2011-12-29
• Last Update Posted: 2011-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Autologous bone marrow stem cell	Autologous bone marrow stem cell	-

Primary Outcome Measures

Name	Time	Method
Barthel index score	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.

Secondary Outcome Measures

Name	Time	Method
NIHSS score and functional status	3, 6 and 12 months post randomization	1. NIHSS score at 6 months and one year post randomization.; 2. 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

Trial Locations

Locations (5)

Post Graduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, Haryana, India

Armed Forces Medical College; 🇮🇳 Pune, Maharastra, India

Sanjay Gandhi Postgraduate Institute of Medical Sciences; 🇮🇳 Lucknow, UttarPradesh, India

All India Institute of Medical Sciences; 🇮🇳 New Delhi, Delhi, India

Army Hospital (R & R Hospital); 🇮🇳 New Delhi, Delhi, India