Intraarterial Stem Cells in Subacute Ischemic Stroke

NCT03080571 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: PGIMER RADIOLOGY
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Conditions

Ischemic Stroke; MCA Infarction

Outcome Measures

Primary Outcomes (4)

• Change in National Institutes of Health Stroke Scale

  increase in National Institutes of Health Stroke Scale more than / equal to 4 points

  6 month

• symptomatic intracranial hemorrhage

  6 month

• new ischemic lesion

  6 month

• Death

  6 month

Secondary Outcomes (1)

• modified rankin score

  6 months

Study Arms (2)

Stem cell group

EXPERIMENTAL

autologous BMMNC stem cells with standard care

Biological: autologous BMMNC stem cells; Other: standard care

Control

ACTIVE COMPARATOR

Patients randomised in this group received standard care only

Other: standard care

Interventions

autologous BMMNC stem cells BIOLOGICAL

Autologous BMMNC injected in the ipsilateral MCA

Stem cell group

standard care OTHER

Control; Stem cell group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Related Publications (5)

• Moniche F, Gonzalez A, Gonzalez-Marcos JR, Carmona M, Pinero P, Espigado I, Garcia-Solis D, Cayuela A, Montaner J, Boada C, Rosell A, Jimenez MD, Mayol A, Gil-Peralta A. Intra-arterial bone marrow mononuclear cells in ischemic stroke: a pilot clinical trial. Stroke. 2012 Aug;43(8):2242-4. doi: 10.1161/STROKEAHA.112.659409. Epub 2012 Jul 3.

  PMID: 22764211 BACKGROUND

• Battistella V, de Freitas GR, da Fonseca LM, Mercante D, Gutfilen B, Goldenberg RC, Dias JV, Kasai-Brunswick TH, Wajnberg E, Rosado-de-Castro PH, Alves-Leon SV, Mendez-Otero R, Andre C. Safety of autologous bone marrow mononuclear cell transplantation in patients with nonacute ischemic stroke. Regen Med. 2011 Jan;6(1):45-52. doi: 10.2217/rme.10.97.

  PMID: 21175286 BACKGROUND

• Suarez-Monteagudo C, Hernandez-Ramirez P, Alvarez-Gonzalez L, Garcia-Maeso I, de la Cuetara-Bernal K, Castillo-Diaz L, Bringas-Vega ML, Martinez-Aching G, Morales-Chacon LM, Baez-Martin MM, Sanchez-Catasus C, Carballo-Barreda M, Rodriguez-Rojas R, Gomez-Fernandez L, Alberti-Amador E, Macias-Abraham C, Balea ED, Rosales LC, Del Valle Perez L, Ferrer BB, Gonzalez RM, Bergado JA. Autologous bone marrow stem cell neurotransplantation in stroke patients. An open study. Restor Neurol Neurosci. 2009;27(3):151-61. doi: 10.3233/RNN-2009-0483.

  PMID: 19531871 BACKGROUND

• Savitz SI, Misra V, Kasam M, Juneja H, Cox CS Jr, Alderman S, Aisiku I, Kar S, Gee A, Grotta JC. Intravenous autologous bone marrow mononuclear cells for ischemic stroke. Ann Neurol. 2011 Jul;70(1):59-69. doi: 10.1002/ana.22458.

  PMID: 21786299 BACKGROUND

• 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.

  PMID: 22507676 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke; Infarction, Middle Cerebral Artery

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cerebral Infarction; Brain Infarction; Brain Ischemia; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Vivek Gupta, DM

  Post Graduate Institute of Medical Education and Research, Chandigarh

  STUDY DIRECTOR

• Vikas Bhatia, DM

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: PROBE design
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: test group :Stem cell plus standard care control group : standard care

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: March 15, 2017
• Study Start: July 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 15, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share