Clinical trial NCT03080571: Intraarterial Stem Cells in Subacute Ischemic Stroke
Official title: To Evaluate the Safety, Feasibility and Clinical Outcome of Intraarterial Infusion of Bone Marrow Derived Mononuclear Cells in Subacute Ischaemic Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ischemic Stroke
MCA Infarction
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2017-03-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: test group :Stem cell plus standard care control group : standard care
Primary purpose: TREATMENT

Brief summary: Stroke is a leading cause of morbidity and mortality.Acute ischemia causes irreversible damage to neurons and glial cells, leading to functional deficits and chronic sequelae with variable degrees of spontaneous recovery of function. Stem cells have been shown to enhance recovery through multiple immunomodulatory effects, neoangiogenesis and neurogenesis.

We conducted a prospective randomised end observer blinded study to evaluate primarily the safety of intraarterial autologous stem cells delivered to ipsilateral middle cerebral artery in acute and subacute stroke patients (0-15 days post ictus).Secondarily we aimed to evaluate the outcome on the basis of clinical evaluation and follow up imaging

Detailed description: 1. This study was done over a period of one and a half years from July 2015 to December 2016. A total of 229 patients who presented with acute middle cerebral artery stroke and admitted at Post graduate institute of medical education and research were evaluated for recruitment into this study.
2. Participants who satisfied the inclusion criteria were randomized at 1 week into control and stem cell infusion test group within 15 days of stroke onset.
3. Investigators evaluated 20 patients, with 10 each in control and stem cell infusion test group.
4. Participants in the test group were infused autologous bone marrow mononuclear cells through intraarterial route using a microcatheter which was placed in proximal ipsilateral M1 segment of MCA. Participants in the control group did not receive stem cell therapy. Rest of the pharmacological treatment and physiotherapy were similar in both groups for the period of 6 months.

5,Participants were evaluated with clinical and radiological follow up at 6 months.

Eligibility criteria: Inclusion Criteria: Requires presence of all of the following

1. Age range 20-80 years symptoms
2. Signs of clinically definite MCA stroke (0 to 14 days post ictus)
3. National Institute of Health Stroke Scale (NIHSS)\> 7,
4. Stroke clinically and on imaging conforming to the MCA territory,
5. Recanalization/patency of involved M1 segment of MCA on imaging
6. Patency of carotid arteries for intra-arterial access of cerebral circulation

Exclusion Criteria: Requires presence of any of the following

1. cerebral hemorrhage on CT/MRI
2. Imaging evidence of M1-MCA segment complete occlusion
3. Hemodynamic instability
4. Known defect of clotting or platelet function
5. Severe co-morbidity precluding intra-arterial intervention
6. Hepatic or renal dysfunction
7. Pregnant patients
8. Patient likely to be unavailable for follow-up
9. Patients with evidence of chronic illness or advanced cancer
10. Patient already dependent in activities of daily living before the present acute stroke i.e. pre stroke mRS \>3
11. Refusal to give informed consent

Primary outcomes:
measure: Change in National Institutes of Health Stroke Scale
timeFrame: 6 month
measure: symptomatic intracranial hemorrhage
timeFrame: 6 month
measure: new ischemic lesion
timeFrame: 6 month
measure: Death
timeFrame: 6 month
Secondary outcomes:
measure: modified rankin score
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: PGIMER
name: Vivek Gupta, DM
role: STUDY_DIRECTOR
affiliation: PGIMER
name: Vikas Bhatia, DM
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Friedrich MA, Martins MP, Araujo MD, Klamt C, Vedolin L, Garicochea B, Raupp EF, Sartori El Ammar J, Machado DC, Costa JC, Nogueira RG, Rosado-de-Castro PH, Mendez-Otero R, Freitas GR. Intra-arterial infusion of autologous bone marrow mononuclear cells in patients with moderate to severe middle cerebral artery acute ischemic stroke. Cell Transplant. 2012;21 Suppl 1:S13-21. doi: 10.3727/096368912x612512.