Clinical Trial with Mesenchymal Stem Cells in Stroke Patients

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

17 Sep 2020 → ongoing

Decision date (initial)

2024-04-03

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-512514-18-00

EudraCT number

2019-001724-35

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

To assess the safety of the intravenous administration of allogeneic stem cells from adipose tissue within the first 4 days from stroke onset in acute ischemic stroke patients.

Secondary objectives 1

1. To assess the potential efficacy of allogeneic stem cells from adipose tissue when administered within the first 4 days from stroke onset in acute ischemic stroke patients.

Conditions and MedDRA coding

ISCHEMIC STROKE

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Male and female acute ischemic patients aged more than 18 years
2. Patients should be treated within 4 days (+/-1 days) from the onset of stroke symptoms. If the time of symptom onset is unknown, this shall refer to the last time the patient was observed as asymptomatic.
3. 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).
4. 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 and in which a measurable focal neurologic deficit persists to the time of treatment.
5. A prestroke score on the Modified Rankin Scale (mRS) ≤1 (no significant disability).
6. Female subjects of non-child bearing potential. Female subjects who are of nonchildbearing potential are defined as meeting at least 1 of the following criteria: o Have undergone a documented hysterectomy and/or bilateral oophorectomy or bilateral salpingectomy; o Have medically confirmed ovarian failure; or o Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
7. Female subjects of child-bearing potential need a confirmed recent menstrual period and negative pregnancy test; and must agree to use adequate contraception for the duration of the study (from screening through the end of study at 24 months since it´s inception). Given human data on pregnancies is not available, the following types of contraception are considered adequate provided they are locally authorized for use: intrauterine contraceptive device, bilateral tubal occlusion, vasectomized partner or sexual abstinence.. Hormonal contraceptive methods, though highly effective, cannot be recommended given their augmented risk of stroke.
8. Signed informed consent

Exclusion criteria 8

1. Comatose patients; patients with a score of 2 or more on item 1a of the NIHSS related to the degree of awareness.
2. Evidence on neuroimaging of a brain tumor, cerebral edema with midline shift and a clinically significant compression of ventricles, cerebellar or brainstem infarction, and intraventricular, intracerebral, or subarachnoid hemorrhage. Petechial small haemorrhages are not exclusion criteria.
3. Current drug or alcohol use or dependence.
4. Active infectious disease, including human immunodeficiency virus, hepatitis B, and hepatitis C. A controlled infection is not an exclusion criterion.
5. Pre-existing dementia.
6. 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.
7. Patients who are participating in another clinical trial.
8. Inability or unwillingness of the individual or their legal guardian/representative to provide written informed consent.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The safety of mesenchymal stem cells from adipose tissue will be assessed using the following parameters: Adverse events (AES) reported spontaneously or in response to questions not addressed. Serious adverse events. Neurological and systemic complications: deteriorating stroke, stroke recurrences, brain oedema, seizures, haemorrhagic transformation, respiratory infections, urinary tract infections, deep venous thrombosis and pulmonary embolism.

Secondary endpoints 3

1. Modified Rankin Scale (mRS): success is considered positive when the patient obtains a score of 0-3, and failure scores of 4 to 6 at months 3, 6, 12 and 24. Additional exploratory efficacy analysis: mRS shift at months 3, 6, 12 and 24.
2. NIH Stroke Scale: It will be measured at all the scheduled visits. Success is considered positive when the patient obtains an improvement of 75% or more from baseline. Additional exploratory efficacy analysis: differences in the distribution of median (IQR) and in the frequency of NIHSS ≤1 between groups.
3. Biochemical markers. They will be measured at baseline, day 7 and month 3.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz

Sponsor organisation

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz

Address

Paseo De La Castellana 261

City

Madrid

Postcode

28046

Country

Spain

Scientific contact point

Organisation

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz

Contact name

Blanca Fuentes Gimeno

Public contact point

Organisation

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz

Contact name

Blanca Fuentes Gimeno

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications