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AzTrials

Ischemic StrokePhase 2NCT02178657

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

A Phase 2 study testing Autologous bone marrow mononuclear cell intra-arterial injection in people with Ischemic Stroke, run by Andalusian Initiative for Advanced Therapies at 4 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Ischemic Stroke
What is being tested?
Autologous bone marrow mononuclear cell intra-arterial injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
4 sitesSpain
Study dates
Apr 2015to 12 Apr 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country.

Spain4 sites

  • Hospital Universitario Puerta del Mar

    Cadiz, 11009

  • Hospital Universitario Reina Sofía

    Córdoba, 14004

  • Hospitales Universitarios Virgen del Rocio

    Seville, 41013

  • Hospitales Universitarios Virgen Macarena

    Seville, 41071

Other trials in Spain

About this study

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.

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.

Read the 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.

Conditions
Ischemic Stroke
Being tested
Autologous bone marrow mononuclear cell intra-arterial injection
Keywords
Stroke, Cell therapy, Bone marrow
Medical subject headings
Ischemic Stroke, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous bone marrow mononuclear cell intra-arterial injectionDrug

Study groups in NCT02178657
Study groupRoleWhat they receive
Bone marrow transplantation low doseExperimentalIntra-arterial autologous bone marrow mononuclear cells injection (dose 2x10^6 per kilogram)
Receives: Drug: Autologous bone marrow mononuclear cell intra-arterial injection
Bone marrow transplantation high doseExperimentalIntra-arterial autologous bone marrow mononuclear cells injection (dose 5x10^6 per kilogram)
Receives: Drug: Autologous bone marrow mononuclear cell intra-arterial injection
ControlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disability

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

    Measured: 6 months

Secondary outcomes (1)

  1. Mortality

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2014 (estimated)
  2. Study startApr 2015
  3. Primary completion27 Oct 2021
  4. Study completion12 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02178657
Sponsor's protocol ID
EudraCT 2013-002135-15
Status last verified
Feb 2024
First submitted
27 Jun 2014
Last updated
7 Feb 2024
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 40304033

  • 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.

    PubMed 36681446

  • 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.

    PubMed 31852749

  • 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.

    PubMed 26044701

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Autologous bone marrow mononuclear cell intra-arterial injection in people with Ischemic Stroke, run by Andalusian Initiative for Advanced Therapies at 4 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disability (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02178657, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.

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