NCT02178657

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2015

Longer than P75 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 1, 2014

Completed
9 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2021

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2023

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

6.6 years

First QC Date

June 27, 2014

Last Update Submit

February 6, 2024

Conditions

Ischemic Stroke

Keywords

StrokeCell therapyBone marrow

Outcome Measures

Primary Outcomes (1)

  • Disability

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

    6 months

Secondary Outcomes (1)

  • Mortality

    24 months

Other Outcomes (5)

  • Functional outcomes

    6 months

  • Infarct volume

    6 months

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    24 months

  • +2 more other outcomes

Study Arms (3)

Bone marrow transplantation low dose

EXPERIMENTAL

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

Drug: Autologous bone marrow mononuclear cell intra-arterial injection

Bone marrow transplantation high dose

EXPERIMENTAL

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

Drug: Autologous bone marrow mononuclear cell intra-arterial injection

Control

NO INTERVENTION

Interventions

Autologous bone marrow mononuclear cell intra-arterial injectionDRUG
Bone marrow transplantation high doseBone marrow transplantation low dose

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Age 18-80 years
  • Written informed consent has been obtained

You may not qualify if:

  • Hemorrhagic stroke or symptomatic hemorrhagic transformation
  • Lacunar infarction
  • Preocclusive stenosis or total occlusion of ipsilateral carotid artery
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital Universitario Puerta del Mar

Cadiz, 11009, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

Location

Hospitales Universitarios Virgen del Rocio

Seville, 41013, Spain

Location

Hospitales Universitarios Virgen Macarena

Seville, 41071, Spain

Location

Related Publications (4)

  • Cabezas-Rodriguez JA, Biarnes C, Marti-Navas M, Pineda V, Comas-Cufi M, Pardo-Galiana B, Zapata-Arriaza E, Pinero P, Aguera-Morales E, Valverde R, Ortega-Quintanilla J, Ainz-Gomez L, Baena-Palomino P, Gutierrez I, Medina-Rodriguez M, Ocete-Perez R, Gamero MA, de Alboniga-Chindurza A, Hermosin A, Aguilar-Perez M, Villagran D, Escamilla-Gomez V, Calderon-Cabrera C, Nogueras S, Jimenez R, Martin V, Herrera C, Delgado F, Gonzalez A, Montaner J, Puig J, Moniche F. Diffusion Tensor Imaging Study After Intraarterial Cell Therapy in Acute Ischemic Stroke: A Substudy of the IBIS Randomized Clinical Trial. Stroke. 2025 Aug;56(8):2198-2209. doi: 10.1161/STROKEAHA.124.050261. Epub 2025 Apr 30.

    PMID: 40304033DERIVED

  • Moniche F, Cabezas-Rodriguez JA, Valverde R, Escudero-Martinez I, Lebrato-Hernandez L, Pardo-Galiana B, Ainz L, Medina-Rodriguez M, de la Torre J, Escamilla-Gomez V, Ortega-Quintanilla J, Zapata-Arriaza E, de Alboniga-Chindurza A, Mancha F, Gamero MA, Perez S, Espinosa-Rosso R, Forero-Diaz L, Moya M, Pinero P, Calderon-Cabrera C, Nogueras S, Jimenez R, Martin V, Delgado F, Ochoa-Sepulveda JJ, Quijano B, Mata R, Santos-Gonzalez M, Carmona-Sanchez G, Herrera C, Gonzalez A, Montaner J. Safety and efficacy of intra-arterial bone marrow mononuclear cell transplantation in patients with acute ischaemic stroke in Spain (IBIS trial): a phase 2, randomised, open-label, standard-of-care controlled, multicentre trial. Lancet Neurol. 2023 Feb;22(2):137-146. doi: 10.1016/S1474-4422(22)00526-9.

    PMID: 36681446DERIVED

  • 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.

    PMID: 31852749DERIVED

  • 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.

    PMID: 26044701DERIVED

MeSH Terms

Conditions

Ischemic StrokeStroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Francisco Moniche, MD, PhD

    Hospitales Universitarios Virgen del Rocio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neurologist

Study Record Dates

First Submitted

June 27, 2014

First Posted

July 1, 2014

Study Start

April 1, 2015

Primary Completion

October 27, 2021

Study Completion

April 12, 2023

Last Updated

February 7, 2024

Record last verified: 2024-02

Locations

ES(4)