Allogeneic Adipose Tissue-derived Mesenchymal Stem Cells in Ischemic Stroke (AMASCIS-02)

May 26, 2023 updated by: Instituto de Investigación Hospital Universitario La Paz

Allogeneic Adipose Tissue-derived Mesenchymal Stem Cells in Ischemic Stroke. A Phase IIB Multicenter Double Blind Placebo Controlled Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Two spanish hospitals with teams experienced in stroke management will participate in this study, recruiting a total of 30 patients between them both. After confirming that patients fulfill the inclusion criteria and none of the exclusion criteria, informed consent will be signed and randomization will take place (1:1). There are two different groups of treatment; the first group will be treated with intravenous alogenic adipose tissue-derived stem cells (at a concentration of one million cells per kg) within the first four days from stroke onset, the second group will be treated will an intravenous placebo solution. Follow-up will last for 24 months during which safety issues such as adverse events and neurological and systemic complications will be assessed at 24 hours, 7 days and 3, 6, 12,18 and 24 months after treatment. Neurological disability using the modified Rankin Scale and National Institute of Health Stroke Scale will also be registered in every scheduled visit. Biochemical markers of tissue repair (GM-CSF, BDNF, VEGF, TGF-1, GFAP, MBP, MMP-3) as well as extracellular vesicles will be extracted on baseline visit as well as 7 days and 3 months after treatment.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 score on the National Institute of Health Stroke Scale (NIHSS) of 8-20, with at least two of these points in sections 5 and 6 (motor deficit) at the time of inclusion. NIHSS evaluation for screening of these patients will take place after finalization of reperfusion therapies (if they have been performed) providing that the clinical condition of the patient is stable with no prevision of immediate recovery. A measurable focal neurologic disabilty must persist to the time of treatment.
  • 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

Exclusion Criteria:

  • Comatose patients; patients with a score of 2 or more on item 1a of the NIHSS related to the degree of awareness.
  • Evidence on neuroimaging of brain tumour, cerebral oedema with midline shift and a clinically significant compression of ventricles, cerebellar or brainstem infarction and intraventricular, intracerebral or subarachnoid haemorrhage. Small petechial haemorrhages are not exclusion criteria.
  • Current drug or alcohol use or dependence
  • Active infectious disease, including human immunodeficiency virus, hepatitis B, and hepatitis C. A controlled infection is not an exclusion criterion.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
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
Concentration of the cells: 10 million cells / ml
Placebo Comparator: Placebo group
15 patients will receive a single intravenous placebo solution with the same appearance as the treatment group.
Drug: Placebo solution
Placebo intravenous solution, same appearance stem cells solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of administration of adipose tissue-derived mesenchymal stem cells measured as reported adverse events
Time Frame: Up to 24 months after treatment or placebo administration
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
Time Frame: Up to 24 months after treatment or placebo administration
Neurological or systemic complications
Up to 24 months after treatment or placebo administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of administration of adipose tissue-derived mesenchymal stem cells measured by the Modified Rankin Scale
Time Frame: Up to 24 months after treatment or placebo administration
Modified Rankin Scale (mRS): success is considered when the patient obtains a score of 0-3, and failure include scores of 4 to 6 at months 3,6,12 and 24. An additional exploratorry efficacy analysis of mRS shift at months 3,6,12 and 24 will also be made.
Up to 24 months after treatment or placebo administration
Efficacy of administration of adipose tissue-derived mesenchymal stem cells measured by the NIHSS
Time Frame: Up to 24 months after treatment or placebo administration
National Institute of Health Stroke Scale. It will be measured at all scheluded visits. Success is defined as an improvement of 75% or more from baseline. An additional exploratory analysis will look for differences in the distribution of median (IQR) and in the frequency of NIHSS ≤ 1between groups.
Up to 24 months after treatment or placebo administration
Efficacy of administration of adipose tissue-derived mesenchymal stem cells measuring blood brain repair biomarkers
Time Frame: Up to 3 months after treatment or placebo administration
Brain repair biomarkers in blood samples (GM-CSF, PDGF-BB, BDNF, VEGF, TGF-1, GFAP, MBP, MMP-3 and extracelular vesicles) measured at baseline, day 7 and mnth 3 after treatment or placebo administration.
Up to 3 months after treatment or placebo administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigación Hospital Universitario La Paz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2021

Primary Completion (Estimated)

July 15, 2023

Study Completion (Estimated)

July 15, 2023

Study Registration Dates

First Submitted

August 6, 2019

First Submitted That Met QC Criteria

February 19, 2020

First Posted (Actual)

February 21, 2020

Study Record Updates

Last Update Posted (Actual)

May 30, 2023

Last Update Submitted That Met QC Criteria

May 26, 2023

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMASCIS - 02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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