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Allogeneic Adipose-Derived Mesenchymal Stem Cells Expanded

Allogeneic Adipose-Derived Mesenchymal Stem Cells (ADMSCs) are emerging as a potential treatment for various medical conditions. This article explores two clinical trials investigating the use of these stem cells in treating abdominal aortic aneurysm (AAA) and acute ischemic stroke. These trials aim to evaluate the safety, feasibility, and potential efficacy of ADMSCs in addressing these serious medical conditions, offering hope for improved patient outcomes and innovative treatment options.

Table of Contents

What Are Allogeneic Adipose-Derived Mesenchymal Stem Cells?

Allogeneic Adipose-Derived Mesenchymal Stem Cells Expanded, also known as e-ASCs or eASCs, are a type of cell therapy being studied for various medical conditions[1][2]. These cells are derived from fat tissue (adipose tissue) of donors and are expanded in a laboratory to increase their numbers. The term “allogeneic” means that the cells come from a donor, not the patient themselves.

Mesenchymal stem cells are special cells that can develop into different types of tissues in the body. They are being studied for their potential to repair and regenerate damaged tissues[1][2].

Medical Conditions Treated

Current research is exploring the use of these stem cells for treating various conditions, including:

  • Abdominal Aortic Aneurysm (AAA): This is a bulge in the wall of the main blood vessel (aorta) that carries blood from the heart to the rest of the body. The stem cells are being studied to see if they can help stabilize the aneurysm after surgical repair[1].
  • Acute Ischemic Stroke: This is a type of stroke caused by a blockage in a blood vessel supplying blood to part of the brain. Researchers are investigating whether these stem cells can help improve recovery in stroke patients[2].

How the Treatment Works

The way these stem cells are administered depends on the condition being treated:

  • For Abdominal Aortic Aneurysm: The stem cells are infused directly into the aneurysm sac during the endovascular repair procedure. The dose is typically 1 million cells per kilogram of the patient’s body weight[1].
  • For Acute Ischemic Stroke: The stem cells are administered intravenously (through a vein) within the first 4 days after the stroke occurs[2].

Safety and Efficacy

The primary focus of current studies is to assess the safety of these stem cell treatments. Researchers are monitoring for any adverse events or complications that might occur after the treatment[1][2].

For AAA treatment, researchers are also looking at how effective the stem cells are in reducing the size of the aneurysm and preventing complications like stent migration or leaks[1].

In stroke treatment, the studies are examining whether the stem cells can improve neurological function and overall recovery in patients[2].

Eligibility for Treatment

Eligibility criteria vary depending on the condition being treated. Some general criteria include:

  • Being 18 years or older
  • Not having certain other medical conditions that might interfere with the treatment or its evaluation
  • For AAA treatment: Having an aneurysm larger than 5 cm in diameter that requires endovascular repair[1]
  • For stroke treatment: Having a stroke of moderate severity (NIHSS score of 8-20) and being treated within 4 days of stroke onset[2]

Potential Side Effects

As these treatments are still in the research phase, all potential side effects may not be known. Researchers are closely monitoring patients for any adverse events, which could include:

  • Allergic reactions
  • Infections
  • Complications related to the specific condition being treated (e.g., aneurysm rupture for AAA patients, or worsening of stroke symptoms for stroke patients)[1][2]

Ongoing Research

These stem cell treatments are still in the clinical trial phase and are not yet approved for general use. Ongoing studies are designed to gather more information about their safety and effectiveness. If you’re interested in participating in a clinical trial, you should discuss this with your healthcare provider to determine if you might be eligible[1][2].

Aspect AAA Trial Stroke Trial
Condition Abdominal Aortic Aneurysm Acute Ischemic Stroke
Main Objective Evaluate safety and feasibility of ADMSC implantation in AAA sac Assess safety of intravenous ADMSC administration
Administration Method Local infusion into aneurysm sac during endovascular repair Intravenous administration within 4 days of stroke onset
Key Inclusion Criteria AAA > 5 cm, eligible for endovascular treatment NIHSS score 8-20, treatment within 4 days of symptom onset
Study Design Single-center, compared with historical cohorts Multicenter, double-blind, placebo-controlled
Primary Endpoints Procedure-related adverse events, ADMSC infusion-related events Adverse events, neurological and systemic complications

FAQ

  • What are Allogeneic Adipose-Derived Mesenchymal Stem Cells? Allogeneic Adipose-Derived Mesenchymal Stem Cells (ADMSCs) are stem cells obtained from fat tissue of donors. These cells have the potential to develop into different types of cells and are being studied for their ability to repair and regenerate damaged tissues in various medical conditions.
  • What conditions are being studied using ADMSCs in these clinical trials? The clinical trials are studying the use of ADMSCs in two conditions: abdominal aortic aneurysm (AAA) and acute ischemic stroke. In the AAA trial, the cells are infused into the aneurysm sac during endovascular repair, while in the stroke trial, they are administered intravenously within the first 4 days of stroke onset.
  • How are the ADMSCs administered in these trials? In the AAA trial, the stem cells are infused locally into the aneurysm sac during the endovascular intervention. For the stroke trial, the cells are administered intravenously within the first 4 days after the onset of stroke symptoms.
  • What are the main objectives of these clinical trials? The main objectives of both trials are to assess the safety of ADMSC administration. Additionally, they aim to evaluate the feasibility of the treatment and gather preliminary data on its efficacy in treating AAA and acute ischemic stroke.
  • Who can participate in these clinical trials? Eligibility varies between the trials. For the AAA trial, patients with AAA greater than 5 cm in diameter and eligible for endovascular treatment can participate. For the stroke trial, adult patients with acute ischemic stroke, a specific range of stroke severity (NIHSS score 8-20), and ability to receive treatment within 4 days of symptom onset may be eligible. Both trials have specific inclusion and exclusion criteria that must be met.

Ongoing Clinical Trials on Allogeneic Adipose-Derived Mesenchymal Stem Cells Expanded

  • Study on Abdominal Aortic Aneurysm Treatment with Allogeneic Adipose-Derived Mesenchymal Stem Cells for Patients Undergoing Endovascular Repair

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

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

    Not recruiting

    2 1 1
    Investigated drugs:
    Spain

Glossary

  • Abdominal Aortic Aneurysm (AAA): A bulge or swelling in the main blood vessel (aorta) that runs from the heart through the abdomen. If left untreated, it can rupture and cause life-threatening bleeding.
  • Acute Ischemic Stroke: A sudden interruption of blood flow to part of the brain, causing a loss of neurologic function. It is typically caused by a blood clot blocking a blood vessel in the brain.
  • Endovascular Repair: A minimally invasive procedure to treat an aneurysm by inserting a graft through small incisions in the groin to reinforce the weakened artery wall.
  • Mesenchymal Stem Cells: A type of multipotent stem cell that can differentiate into various cell types, including bone, cartilage, muscle, and fat cells. They have potential regenerative and anti-inflammatory properties.
  • Allogeneic: Referring to cells, tissues, or organs that are sourced from a genetically different donor of the same species.
  • NIHSS (National Institute of Health Stroke Scale): A tool used to objectively quantify the impairment caused by a stroke. The scale measures level of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss.
  • Modified Rankin Scale (mRS): A scale for measuring the degree of disability or dependence in daily activities of people who have suffered a stroke or other neurological disabilities.
  • Placebo: A substance or treatment with no active therapeutic effect, used as a control in clinical trials to test the effectiveness of new treatments.
  • Double-blind Study: A study design in which neither the participants nor the researchers know who is receiving the experimental treatment and who is receiving a placebo or standard treatment.

References

  1. http://clinicaltrials.eu/trial/study-on-abdominal-aortic-aneurysm-treatment-with-allogeneic-adipose-derived-mesenchymal-stem-cells-for-patients-undergoing-endovascular-repair/
  2. http://clinicaltrials.eu/trial/study-on-the-safety-of-allogeneic-adipose-derived-mesenchymal-stem-cells-for-patients-with-acute-ischemic-stroke/