Intraarterial Stem Cells in Subacute Ischemic Stroke

Ischemic Stroke Clinical Trial

Official title:

To Evaluate the Safety, Feasibility and Clinical Outcome of Intraarterial Infusion of Bone Marrow Derived Mononuclear Cells in Subacute Ischaemic Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03080571
• Other study ID #: PGIMER RADIOLOGY
• Status: Completed
• Phase: Phase 1
• First received: March 7, 2017
• Last updated: March 14, 2017
• Start date: July 2015
• Est. completion date: December 2016

Study information

• Verified date: March 2017
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Infarction
• Infarction, Middle Cerebral Artery
• Ischemia
• Ischemic Stroke
• MCA Infarction
• Stroke

Intervention

Biological:
• autologous BMMNC stem cells
Autologous BMMNC injected in the ipsilateral MCA

Other:
• standard care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

References & Publications (5)

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. — View Citation

Friedrich MA, Martins MP, Araújo 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. — View Citation

Moniche F, Gonzalez A, Gonzalez-Marcos JR, Carmona M, Piñero 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. — View Citation

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. — View Citation

Suárez-Monteagudo C, Hernández-Ramírez P, Alvarez-González L, García-Maeso I, de la Cuétara-Bernal K, Castillo-Díaz L, Bringas-Vega ML, Martínez-Aching G, Morales-Chacón LM, Báez-Martín MM, Sánchez-Catasús C, Carballo-Barreda M, Rodríguez-Rojas R, Gómez-Fernández L, Alberti-Amador E, Macías-Abraham C, Balea ED, Rosales LC, Del Valle Pérez L, Ferrer BB, González 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in National Institutes of Health Stroke Scale	increase in National Institutes of Health Stroke Scale more than / equal to 4 points	6 month
Primary	symptomatic intracranial hemorrhage		6 month
Primary	new ischemic lesion		6 month
Primary	Death		6 month
Secondary	modified rankin score	A modified rankin score of 0-1 in patients with National Institutes of Health Stroke Scale of 8-14 at the admission and modified rankin score of 0-2 in patients with National Institutes of Health Stroke Scale >14 at the admission.	6 months