Intra-arterial Bone-marrow Mononuclear Cells Infusion for Acute Ischemic Stroke

Ischemic Stroke Clinical Trial

Official title:

Intra-arterial Autologous Bone-marrow Mononuclear Cells Infusion for Acute Ischemic Stroke. A Phase II, Open-label, Multicenter, Randomized and Controlled Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02178657
• Other study ID #: EudraCT 2013-002135-15
• Status: Completed
• Phase: Phase 2
• Start date: April 2015
• Est. completion date: April 12, 2023

Study information

• Verified date: February 2024
• Source: Andalusian Initiative for Advanced Therapies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial aims to test that intra-arterial injection of autologous bone marrow mononuclear cells in acute ischemic stroke patients is safe and improves neurological outcomes.

Description:

This is a study in which the patients will be included diagnosed of ischemic stroke sharply in the territory of the cerebral average artery that there fulfill criteria of incorporation and none of those of exclusion and that they have signed the informed assent. 76 patients will randomize in proportion 2:1:1 in a group control that will receive only medical conventional treatment and in two groups of intervention that will receive an unique intra-arterial infusion of mononuclear autologous bone marrow stem cells (one group of dose of 2 millions of BMSC for kilogram of weight and another group of dose of 5 millions of BMSC for kilogram of weight). The three groups of patients will be followed for 24 months. The randomization will be stratified depending on the NHSS score. This clinical trial has a voluntary substudy to obtain information on plasma biomarkers.

Other known NCT identifiers

• NCT02290483

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: April 12, 2023
• Est. primary completion date: October 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with middle cerebral artery (MCA) acute ischemic stroke.

• Time of stroke onset is known and treatment can be started between day 1 and 7 of onset.

• DWI-MRI has reliably shown acute MCA ischemic lesions

• Magnetic resonance angiography (MRA) must confirm ipsilateral MCA permeability

• National Institute of Health Stroke Scale score of 6-20 at inclusion

• Age 18-80 years

• Written informed consent has been obtained

Exclusion Criteria:

• Hemorrhagic stroke or symptomatic hemorrhagic transformation

• Lacunar infarction

• Preocclusive stenosis or total occlusion of ipsilateral carotid artery

• Worsening of =4 points in National Institute of Health Stroke Scale in the 24 hours previous to inclusion, attributable to edema or hemorrhagic transformation or suspicious of malignant edema

• Decrease of consciousness with a Glasgow Coma Scale of <8 points

• Patients with present or previous malignant disease during the last 5 years, except for basal cell carcinoma

• Contraindication for MRI or for bone marrow harvest

• Previous diagnosis of neurodegenerative disease

• Acute heart failure

• Hepatic or renal dysfunction (creatinine >2mg/dL)

• Coagulopathy

• Severe co-morbidity

• Pregnancy, childbearing potential (unless it is certain that pregnancy is not possible) or breast feeding

• Modified Rankin Score (mRS) before stroke of =2

• Participation in any clinical trial in the last 3 months

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Autologous bone marrow mononuclear cell intra-arterial injection

Locations

Country	Name	City	State
Spain	Hospital Universitario Puerta del Mar	Cadiz
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	Hospitales Universitarios Virgen del Rocio	Seville
Spain	Hospitales Universitarios Virgen Macarena	Seville

Sponsors (1)

Lead Sponsor	Collaborator
Andalusian Initiative for Advanced Therapies

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Functional outcomes	Functional outcome measure by National Institute of Health Stroke Scale and Barthel at 6 months	6 months
Other	Infarct volume	Infarct volume change between baseline (DWI) and 6 months (FLAIR)	6 months
Other	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		24 months
Other	Number of Participants with new-onset seizures as a Measure of Safety and Tolerability		6 months
Other	Functional outcomes	Categorical shift in mRS ordinal (0-6) scale	6 months
Primary	Disability	Proportion of patients with modified Rankin Scale scores of 0-2 at 6 months	6 months
Secondary	Mortality		24 months