NCT04280003

Brief Summary

This is a multicenter, doble blind, placebo controlled clinical trial to asses de safety and efficacy of intravenous administration of alogenic adipose tissue-derived mesenchymal stem cells in the first four days from acute ischemic stroke.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

August 6, 2019

Completed
7 months until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

January 20, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2023

Completed
Last Updated

May 30, 2023

Status Verified

May 1, 2022

Enrollment Period

2.5 years

First QC Date

August 6, 2019

Last Update Submit

May 26, 2023

Conditions

Ischemic StrokeAdipose Tissue-derived Stem CellFunctional Status

Outcome Measures

Primary Outcomes (2)

  • Safety of administration of adipose tissue-derived mesenchymal stem cells measured as reported adverse events

    Adverse events reported spontaneously or in response to questions not addressed.

    Up to 24 months after treatment or placebo administration

  • Safety of administration of adipose tissue-derived mesenchymal stem cells measured as neurological o systemic complications

    Neurological or systemic complications

    Up to 24 months after treatment or placebo administration

Secondary Outcomes (3)

  • Efficacy of administration of adipose tissue-derived mesenchymal stem cells measured by the Modified Rankin Scale

    Up to 24 months after treatment or placebo administration

  • Efficacy of administration of adipose tissue-derived mesenchymal stem cells measured by the NIHSS

    Up to 24 months after treatment or placebo administration

  • Efficacy of administration of adipose tissue-derived mesenchymal stem cells measuring blood brain repair biomarkers

    Up to 3 months after treatment or placebo administration

Study Arms (2)

Treatment group

EXPERIMENTAL

15 patients will receive intravenous alogenic adipose tissue-derived stem cells in a single dose of one million cells per kg.

Other: Alogenic adipose tissue-derived stem cells

Placebo group

PLACEBO COMPARATOR

15 patients will receive a single intravenous placebo solution with the same appearance as the treatment group.

Drug: Placebo solution

Interventions

Alogenic adipose tissue-derived stem cellsOTHER

Concentration of the cells: 10 million cells / ml

Treatment group
Placebo solutionDRUG

Placebo intravenous solution, same appearance stem cells solution

Placebo group

Eligibility Criteria

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

You may qualify if:

  • Ischemic stroke patients \> 18 years old
  • Patients must be able to be treated within the first 4 days (+/- 1) from acute stroke symptoms onset. If the time of symptom onset is unknown, this shall refer to the last time the patient was observed as asymptomatic.
  • A computed tomography (CT) or magnetic resonance imaging (MRI) scan compatible with the clinical diagnosis of acute non-lacunar IS in the region of the middle cerebral artery (with cortical or subcortical involvement).
  • A prestroke score on the Modified Rankin Scale (mRS) ≤1 (no significant disability).
  • Female subjects non-child bearing potential. Female subjects who are of non-childbearing potential are defined as meeting at least 1 of the following criteria:
  • Have undergone a documented hysterectomy and/or bilateral oophorectomy; Have medically confirmed ovarian failure; or Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause.
  • Female subjects of child-bearing potential need a negative pregnancy test and must agree to use adequate contraception for the duration of the study (from screening through the final of the study). The following types of contraception are considered adequate provided they are locally authorized for use: oral, transdermal, or injectable (depot) estrogen and/or progestogen, selective estrogen receptor modulator therapy, intrauterine contraceptive device, double barrier method (e.g., condom and diaphragm or spermicidal gel) or vasectomy.
  • Signed informed consent

You may not qualify if:

  • Comatose patients; patients with a score of 2 or more on item 1a of the NIHSS related to the degree of awareness.
  • Current drug or alcohol use or dependence
  • Pre-existing dementia.
  • A health status, any clinical condition (eg, short life expectancy, and coexisting disease or a surgical or endovascular planned procedure) or other characteristic that precludes appropriate diagnosis, treatment, or follow-up in the trial.
  • Patients who are participating in another clinical trial.
  • Inability or unwillingness of the individual or their legal guardian/representative to provide written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Related Publications (1)

  • de Celis-Ruiz E, Fuentes B, Moniche F, Montaner J, Borobia AM, Gutierrez-Fernandez M, Diez-Tejedor E. Allogeneic adipose tissue-derived mesenchymal stem cells in ischaemic stroke (AMASCIS-02): a phase IIb, multicentre, double-blind, placebo-controlled clinical trial protocol. BMJ Open. 2021 Aug 9;11(8):e051790. doi: 10.1136/bmjopen-2021-051790.

    PMID: 34373315BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Blanca Fuentes Gimeno

CONTACT

917277444blanca.fuentes@salud.madrid.org

Elena de Celis Ruiz

CONTACT

917277444elena.decelis@salud.madrid.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Treatment and placebo solutions have identical appearance. Protocols will be designed to ensure that the physician evaluating patient safety and efficacy outcome as well as laboratory analysis, will not have access to the randomisation codes.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two different treatment grupos; intravenous alogenic adipose tissue-derived mesenchymal stem cells or intravenous placebo solution
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2019

First Posted

February 21, 2020

Study Start

January 20, 2021

Primary Completion

July 15, 2023

Study Completion

July 15, 2023

Last Updated

May 30, 2023

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

Data will be available from the corresponding author on reasonable request, considered compliant General Data Protection Regulation and the data-sharing agreement is approved by the relevant Spanish authorities. Upon study finalization, anonymized individual patient data will be available on a public repertoire of the Community of Madrid.

Locations

ES(1)