NCT06488898 Abdominal Aortic Aneurysm Stabilization With Truncal Cells: Controlled Clinical Trial With Historical Cohorts
| NCT ID | NCT06488898 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Instituto de Investigación Hospital Universitario La Paz |
| Condition | Aortic Aneurysm, Abdominal |
| Study Type | INTERVENTIONAL |
| Enrollment | 8 participants |
| Start Date | 2024-06-13 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 8 participants in total. It began in 2024-06-13 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Phase IIa, single-center clinical trial compared with historical cohorts to evaluate the preliminary safety and efficacy of an allogeneic adipose tissue-derived mesenchymal stem cells infusion in an aneurysmal sac for the treatment of AAA.
Eligibility Criteria
Inclusion Criteria: 1. Subjects with AAA greater than 5 cm diameter with endovascular treatment indication, analyzed by aortic AngioCT. 2. Subjects ≥ 18 years at the time of inclusion. 3. Subjects with a good infrarenal neck for a standard device placement, neither fenestrated nor branched. 4. Patients with an estimated life expectancy greater than 2 years at the time of inclusion. 5. Women with childbearing capacity must have a negative pregnancy test at the time of inclusion and must agree to use highly effective contraceptive methods (diaphragms plus spermicide or male condom plus spermicide, oral contraceptive combined with a second method contraceptive implant, injectable contraceptive, permanent intrauterine device, sexual abstinence or partner with vasectomy) during their study participation. 6. The patient must be able to attend all study visits and comply with all study procedures. Exclusion Criteria: 1. Patients with unresolved neoplasia history or hematologic disease. 2. Patients with uncontrolled arterial hypertension (≥180/110) at the time of inclusion. 3. Patients with severe heart failure (New York Heart Association \[NYHA\] IV) or ejection fraction \<20%. 4. Patients with malignant ventricular arrhythmias 5. Patients with deep vein thrombosis the last three months 6. Patient with active sepsis at the time of inclusion 7. Patients with acute myocardial infarction or stroke in the previous month 8. Any type of medical or psychiatric illness that, in investigator opinion, could be a reason for exclusion from the study. 9. Patient with major surgery or severe craniocerebral trauma in the 3 months prior to inclusion in the study. 10. Administration of any investigational drug at the time of inclusion or in the 3 months prior 11. Infants or pregnant women 12. Transplanted patients.
Frequently Asked Questions
Who can join the NCT06488898 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Aneurysm, Abdominal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06488898 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06488898 currently recruiting?
Yes, NCT06488898 is actively recruiting participants. Visit ClinicalTrials.gov or contact Instituto de Investigación Hospital Universitario La Paz to inquire about joining.
Where is the NCT06488898 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT06488898 clinical trial?
NCT06488898 is sponsored by Instituto de Investigación Hospital Universitario La Paz. The trial plans to enroll 8 participants.