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

Primary Purpose

Ischemic Stroke

Status
Active
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Autologous bone marrow mononuclear cell intra-arterial injection
Sponsored by
Andalusian Initiative for Advanced Therapies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring Stroke, Cell therapy, Bone marrow

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitario Puerta del Mar
  • Hospital Universitario Reina Sofía
  • Hospitales Universitarios Virgen del Rocio
  • Hospitales Universitarios Virgen Macarena

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Bone marrow transplantation low dose

Bone marrow transplantation high dose

Control

Arm Description

Intra-arterial autologous bone marrow mononuclear cells injection (dose 2x10^6 per kilogram)

Intra-arterial autologous bone marrow mononuclear cells injection (dose 5x10^6 per kilogram)

Outcomes

Primary Outcome Measures

Disability
Proportion of patients with modified Rankin Scale scores of 0-2 at 6 months

Secondary Outcome Measures

Mortality

Full Information

First Posted
June 27, 2014
Last Updated
February 15, 2022
Sponsor
Andalusian Initiative for Advanced Therapies
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1. Study Identification

Unique Protocol Identification Number
NCT02178657
Brief Title
Intra-arterial Bone-marrow Mononuclear Cells Infusion for Acute Ischemic Stroke
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2015 (undefined)
Primary Completion Date
October 27, 2021 (Actual)
Study Completion Date
April 12, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Andalusian Initiative for Advanced Therapies

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
Stroke, Cell therapy, Bone marrow

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bone marrow transplantation low dose
Arm Type
Experimental
Arm Description
Intra-arterial autologous bone marrow mononuclear cells injection (dose 2x10^6 per kilogram)
Arm Title
Bone marrow transplantation high dose
Arm Type
Experimental
Arm Description
Intra-arterial autologous bone marrow mononuclear cells injection (dose 5x10^6 per kilogram)
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Autologous bone marrow mononuclear cell intra-arterial injection
Primary Outcome Measure Information:
Title
Disability
Description
Proportion of patients with modified Rankin Scale scores of 0-2 at 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Mortality
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Functional outcomes
Description
Functional outcome measure by National Institute of Health Stroke Scale and Barthel at 6 months
Time Frame
6 months
Title
Infarct volume
Description
Infarct volume change between baseline (DWI) and 6 months (FLAIR)
Time Frame
6 months
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
24 months
Title
Number of Participants with new-onset seizures as a Measure of Safety and Tolerability
Time Frame
6 months
Title
Functional outcomes
Description
Categorical shift in mRS ordinal (0-6) scale
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Moniche, MD, PhD
Organizational Affiliation
Hospitales Universitarios Virgen del Rocio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Puerta del Mar
City
Cadiz
ZIP/Postal Code
11009
Country
Spain
Facility Name
Hospital Universitario Reina Sofía
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospitales Universitarios Virgen del Rocio
City
Seville
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospitales Universitarios Virgen Macarena
City
Seville
ZIP/Postal Code
41071
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
31852749
Citation
Mancha F, Escudero-Martinez I, Zapata-Arriaza E, Vega-Salvatierra A, Cabezas JA, Lebrato L, Pardo B, De-La-Torre J, Zapata M, Escamilla V, Calderon-Cabrera C, Martin-Sanchez J, Valverde R, Aguera-Morales E, Herrera I, Delgado F, Gamero MA, Perez-Sanchez S, Moya M, Espinosa R, Ortega-Quintanilla J, Gutierrez-Jarrin I, Gonzalez-Garcia A, Montaner J, Moniche F. Circulating microRNA after autologous bone marrow mononuclear cell (BM-MNC) injection in patients with ischemic stroke. J Investig Med. 2020 Mar;68(3):807-810. doi: 10.1136/jim-2019-001161. Epub 2019 Dec 17.
Results Reference
derived
PubMed Identifier
26044701
Citation
Moniche F, Escudero I, Zapata-Arriaza E, Usero-Ruiz M, Prieto-Leon M, de la Torre J, Gamero MA, Tamayo JA, Ochoa-Sepulveda JJ, Maestre J, Carmona M, Pinero P, Calderon-Cabrera C, Jimenez MD, Gonzalez A, Montaner J. Intra-arterial bone marrow mononuclear cells (BM-MNCs) transplantation in acute ischemic stroke (IBIS trial): protocol of a phase II, randomized, dose-finding, controlled multicenter trial. Int J Stroke. 2015 Oct;10(7):1149-52. doi: 10.1111/ijs.12520. Epub 2015 Jun 4.
Results Reference
derived

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

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