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Study on the Safety of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Patients with Acute Ischemic Stroke

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment for patients who have experienced an ischemic stroke. An ischemic stroke occurs when a blood clot blocks or narrows an artery leading to the brain, causing a reduction in blood flow. The treatment being tested involves the use of allogeneic adipose-derived mesenchymal stem cells expanded, which are special cells taken from fat tissue and grown in a lab. These cells are then injected into the patient to see if they can help improve recovery after a stroke.

The main purpose of this study is to assess the safety of these stem cells when given to patients within the first four days after their stroke. The study is designed to be a double-blind trial, meaning neither the patients nor the researchers know who is receiving the stem cells and who is receiving a placebo. This helps ensure that the results are not biased. Participants will receive the treatment through an injection and will be monitored closely for any side effects or complications, such as worsening of the stroke, new strokes, or infections.

Throughout the study, patients will have regular check-ups to assess their recovery and any changes in their condition. These check-ups will include evaluations using the Modified Rankin Scale (mRS) and the NIH Stroke Scale, which are tools used to measure the level of disability and improvement after a stroke. The study will also look at various biochemical markers in the blood to gather more information about how the treatment is working. The trial is expected to continue until the end of 2026, with follow-up visits scheduled at several points over the next two years to track the long-term effects of the treatment.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, stroke type, and health status.

    A signed informed consent is required to participate.

  2. Step 2

    Initial assessment

    An initial assessment is conducted, including a CT or MRI scan to confirm the diagnosis of acute ischemic stroke.

    The National Institute of Health Stroke Scale (NIHSS) is used to evaluate the severity of the stroke.

  3. Step 3

    Treatment administration

    The treatment involves the intravenous administration of allogeneic adipose-derived mesenchymal stem cells.

    This is administered as a solution for injection within the first 4 days from the onset of stroke symptoms.

  4. Step 4

    Monitoring and follow-up

    Regular follow-up visits are scheduled to monitor safety and effectiveness.

    The Modified Rankin Scale (mRS) and NIH Stroke Scale are used to assess recovery at months 3, 6, 12, and 24.

    Biochemical markers are measured at baseline, day 7, and month 3.

  5. Step 5

    Safety assessment

    Safety is evaluated by monitoring for adverse events and complications such as infections or stroke recurrence.

    Any serious adverse events are documented and analyzed.

  6. Step 6

    Completion of the study

    The study is expected to conclude by December 31, 2026.

    Final assessments are conducted to evaluate long-term outcomes and safety.

Who can join the trial?

8 criteria

  • Both men and women who have had an acute ischemic stroke and are older than 18 years can participate. An acute ischemic stroke is a type of stroke caused by a blockage in a blood vessel in the brain.
  • Participants should receive treatment within 4 days (plus or minus 1 day) from when stroke symptoms started. If the exact time of symptom onset is unknown, it refers to the last time the person was seen without symptoms.
  • A CT (computed tomography) or MRI (magnetic resonance imaging) scan must show results that match the diagnosis of an acute non-lacunar ischemic stroke in the middle cerebral artery area, which involves either the outer or inner parts of the brain.
  • The participant must have a score between 8 and 20 on the National Institute of Health Stroke Scale (NIHSS), with at least two points in sections 5 and 6, which relate to motor skills, at the time of joining the study. A measurable focal neurological deficit should still be present at the time of treatment. The NIHSS is a tool used to measure the severity of a stroke.
  • Before the stroke, the participant should have a score of 1 or less on the Modified Rankin Scale (mRS), indicating no significant disability. The mRS is a scale that measures the degree of disability or dependence in daily activities.
  • Female participants who cannot have children must meet at least one of the following: have had a hysterectomy (removal of the uterus), bilateral oophorectomy (removal of both ovaries), bilateral salpingectomy (removal of both fallopian tubes), confirmed ovarian failure, or be postmenopausal (no menstrual periods for at least 12 months without other causes).
  • Female participants who can have children must have a recent menstrual period and a negative pregnancy test. They must agree to use effective birth control during the study, such as an intrauterine device, bilateral tubal occlusion, a partner with a vasectomy, or abstinence. Hormonal contraceptives are not recommended due to increased stroke risk.
  • Participants must sign an informed consent form, which means they agree to join the study after understanding its details.

Who cannot join the trial?

4 criteria

  • Patients who have had a stroke caused by a blockage in a blood vessel in the brain, known as an ischemic stroke, cannot participate if it has been more than 4 days since the stroke occurred.
  • Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study organizers.
  • Patients who belong to certain groups that the study is not targeting cannot participate. These groups are defined by the study organizers.
  • Patients who are considered part of a vulnerable population cannot participate. A vulnerable population includes people who might be at higher risk of harm or exploitation, such as children, pregnant women, or those with certain disabilities.
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Investigated drugs

Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells are being studied for their potential to help patients who have had an ischemic stroke. These stem cells are taken from donated fat tissue and are given to patients through an intravenous infusion. The goal is to see if these stem cells can be safely used to help repair damage caused by the stroke when administered within the first few days after the stroke occurs.

What is already known about the treatment

Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells – This medication is administered intravenously and is currently being studied in clinical trials for its potential use in treating ischemic stroke. The main therapeutic indication is to improve outcomes in patients who have suffered an acute ischemic stroke. The mechanism of action involves the cells' ability to modulate the immune response and promote tissue repair at the molecular level. It is classified under cell-based therapies, specifically using stem cells derived from adipose tissue.

Investigated diseases

Ischemic Stroke – Ischemic stroke occurs when a blood clot blocks or narrows an artery leading to the brain, resulting in reduced blood flow and oxygen to brain tissue. This blockage can cause brain cells to begin dying within minutes, leading to potential loss of brain function. Symptoms often include sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, or difficulty understanding speech. As the condition progresses, individuals may experience vision problems, dizziness, loss of balance, or severe headache. The severity and specific symptoms depend on the location and extent of the blockage in the brain. Recovery and progression can vary widely among individuals, with some experiencing significant improvement and others facing long-term challenges.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512514-18-00Protocol codeAMASCIS-02Estimated enrolment30 patientsSponsorFundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz

sourced from the EU Clinical Trials Register and site verification

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