Actively Recruiting
Abdominal Aortic Aneurysm Stabilization With Truncal Cells: Controlled Clinical Trial With Historical Cohorts
Led by Instituto de Investigación Hospital Universitario La Paz · Updated on 2024-07-08
8
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Instituto de Investigación Hospital Universitario La Paz
Lead Sponsor
G
Grupo Dermatologico Y Estetico Pedro Jaen S.A.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the preliminary safety and effectiveness of an infusion of allogeneic adipose tissue-derived mesenchymal stem cells into the aneurysmal sac for treating abdominal aortic aneurysm (AAA). This Phase IIa, single-center clinical trial compares the investigational treatment with historical patient groups to better understand its potential benefits and risks for patients with AAA who require endovascular treatment. The investigational treatment involves a single local injection of expanded allogeneic adipose tissue-derived mesenchymal stem cells delivered via catheter directly into the aneurysm sac during the endovascular AAA procedure. The dose is calculated as 10 million cells per kilogram of patient body weight. These stem cells are classified as an advanced therapy medicinal product under European regulations. Participants will be monitored for safety over 12 months following treatment, and the effectiveness of the intervention will be evaluated at 6 months. Study visits will include assessments and procedures to track patient health and aneurysm stability. The total duration of involvement includes these follow-up periods to ensure comprehensive monitoring of outcomes and any potential side effects.
CONDITIONS
Brief Title
Abdominal Aortic Aneurysm Stabilization With Truncal Cells: Controlled Clinical Trial With Historical Cohorts
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of abdominal aortic aneurysm greater than 5 cm diameter requiring endovascular treatment confirmed by aortic AngioCT
- Age 18 years or older at the time of inclusion
- Suitable infrarenal neck anatomy for standard device placement (not fenestrated or branched)
- Estimated life expectancy greater than 2 years
- Women of childbearing potential must have a negative pregnancy test and agree to use highly effective contraception during the study
- Ability to attend all study visits and comply with study procedures
You will not qualify if you...
- History of unresolved cancer or blood disorders
- Uncontrolled high blood pressure (≥180/110 mmHg) at inclusion
- Severe heart failure (New York Heart Association Class IV) or ejection fraction below 20%
- Malignant ventricular arrhythmias
- Deep vein thrombosis within the last three months
- Active sepsis at the time of inclusion
- Acute heart attack or stroke within the previous month
- Any medical or psychiatric illness that may exclude participation per investigator judgment
- Recent major surgery or severe head trauma within three months prior to inclusion
- Use of any investigational drug at inclusion or in the previous three months
- Infants or pregnant women
- Patients with organ transplants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of endovascular intervention
Participants receive a single infusion of allogeneic adipose tissue-derived mesenchymal stem cells by local injection during the endovascular abdominal aortic aneurysm intervention.
1 visit (in-person)
Duration - Up to 12 months
Participants are monitored for safety and efficacy of the treatment over time.
Regular visits during 12 months
Trial Site Locations
Total: 1 location
1
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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