Regenerative Stem Cell Therapy for Stroke in Europe 1-RESSTORE1

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Enrolling; Phase 1

Conditions: Stroke

Treatments: Other: placebo; Drug: Adipose derived Stem Cell

Study type: Interventional

Funder types: Other

Identifiers

NCT03570450

38RC17.312

Details and patient eligibility

About

Stroke is the second leading cause of death in the world population. When not fatal, stroke often results in disability, and secondary health problems affecting not only patients but also their families. Building on emerging preclinical and pilot clinical evidences, RESSTORE will focus on the clinical assessment of regenerative cell therapy to improve stroke recovery and patients quality of life.

Enrollment: 95 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Inclusion criteria are similar in the phase 1a (RESSTORE 1a, Toxicity study) and in the phase 1b (RESSTORE 1b, Dose-effect study).

• Male or female > 18-year-old
• Hemispheric ischemic stroke (> 1.5 cm on 2 imaging slices) (i.e. non "lacunar" stroke) Admitted to the stroke unit within the first 24h after stroke onset
• Patient must be included within 1st and 2nd day after stroke onset (signature of informed consent and randomization) (i.e. between 24 hours and 48 hours from stroke onset) and must be able to receive investigation treatment within the first week.
• NIHSS > or equal to 7 including motor score (upper, lower limbs and hand) > or equal to 3
• No decompressive craniectomy procedure planned or performed
• Patient able to follow a rehabilitation program
• Modified Rankin scale = 0 before stroke onset
• Obtained signed informed consent from patient or legally acceptable representative
• Negative pregnancy test for women of child-bearing age.

Non Inclusion Criteria:

Non-inclusion criteria are similar in the phase 1a (RESSTORE 1a, Toxicity study) and the phase 1b (RESSTORE 1b, Dose-effect study).

• Contraindication for MRI
• Coma (score of 2 or more on item 1a of the NIHSS related to awareness)
• Evidence on neuroimaging (CT or MRI) of a brain tumour, cerebral oedema with midline shift and a clinically significant compression of ventricles, cerebellar or brainstem infarction, or subarachnoid haemorrhage, or intracerebral parenchymal hematoma (petechial small haemorrhages are NOT a non-inclusion criteria)
• Severe leucoariosis
• Previous stroke
• Active endocarditis, pneumonia, AIDS, active hepatic disease due to HBV or HCV (a controlled infection is NOT a non-inclusion criteria)
• Active inflammatory and/or auto-immune diseases (such as Crohn disease, lupus, rheumatoid polyarthritis, renal or liver immune pathology)
• History of cancer
• Pre-existing dementia
• A health status, any clinical condition (eg, short life expectancy, and coexisting disease) or other characteristic that precludes appropriate diagnosis, treatment, or follow-up in the trial
• Surgical or endovascular procedure planned in the following 3 months
• Pregnancy / Breast feeding (women of childbearing age should have a negative pregnancy test prior to inclusion)
• Patients who are participating in another therapeutic trial or who have previously participated in a biotherapy trial
• Non-membership to a social security scheme
• Inability or unwillingness of the individual or their legal guardian/representa tive to provide written informed consent, according to national regulations.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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95 participants in 5 patient groups, including a placebo group

Adipose derived Stem Cells - 1.10^6cells/kg

Experimental group

Description:

ADSC, single, IV, 1.10\^6cells/kg

Treatment:

Drug: Adipose derived Stem Cell

Adipose derived Stem Cells - 2.10^6cells/kg

Experimental group

Description:

ADSC, single, IV, 2.10\^6cells/kg

Treatment:

Drug: Adipose derived Stem Cell

Adipose derived Stem Cells - 2,5.10^6cells/kg

Experimental group

Description:

ADSC, single, IV, 2,5.10\^6cells/kg

Treatment:

Drug: Adipose derived Stem Cell

Adipose derived Stem Cells - 3.10^6cells/kg

Experimental group

Description:

ADSC, single, IV, 3.10\^6cells/kg

Treatment:

Drug: Adipose derived Stem Cell

placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: placebo