"Abdominal Aortic Aneurysm Stabilization with mesenchymal stem Cells"

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Grupo Dermatologico Y Estetico Pedro Jaen S.A.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Not possible to specify

Trial duration

12 Jun 2024 → ongoing

Decision date (initial)

2024-02-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

To evaluate the safety and feasibility of an allogeneic adipose tissue-derived mesenchymal stem cell implantation in the sac of an abdominal aortic aneurysm treated by endoprosthesis.

Secondary objectives 2

1. To evaluate the preliminary efficacy of mesenchymal stem cell therapy in the stent-treated abdominal aortic aneurysm sac compared with a historical cohort with conventional endovascular treatment.
2. To compare the clinical evolution of patients undergoing endovascular surgical repair with infusion of mesenchymal stem cells into the aneurysm sac with the historical cohort.

Conditions and MedDRA coding

Patients with abdominal aortic aneurysm undergoing endovascular surgical repair.

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Subjects with AAA greater than 5 cm in diameter with indication for endovascular treatment, analyzed by aortic AngioCT.
2. Subjects ≥ 18 years of age at the time of inclusion.
3. Subjects with a good infrarenal neck for placement of a standard device, neither fenestrated nor branched.
4. Patients with an estimated life expectancy greater than two years at inclusion.
5. Women of childbearing potential must have a negative pregnancy test at 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 participation in the study.
6. The patient must be able to attend all study visits and abide by all study procedures.

Exclusion criteria 12

1. Patients with a history of unresolved neoplasm or hematologic disease.
2. Patients with uncontrolled arterial hypertension (≥180/110) at 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 in the last three months.
6. Patient with active septic picture at the time of inclusion.
7. Patients with acute myocardial infarction or stroke the previous month.
8. Medical or psychiatric illness of any kind that, in the opinion of the investigator, may 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 three months prior.
11. Women who are breastfeeding or pregnant women.
12. Transplanted patients.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Proportion of procedure-related adverse events occurring throughout the study.
2. Proportion of adverse events related to allogeneic adipose tissue-derived mesenchymal stem cell infusion occurred throughout the study.
3. Proportion of patients with major adverse cerebral and cardiovascular events (MACCE) within 12 months after treatment.

Secondary endpoints 6

1. Reduction of the size of the aneurysm sac in the imaging tests performed during follow-up (CT and Doppler echo). A reduction in the maximum diameter of the aneurysm sac greater than or equal to 5mm in a period of 6 months is considered significant.
2. Percentage of patients with stent migration compared to the historical cohort.
3. Percentage of patients with presence of leaks on control CT at 1 month and 1 year compared to the historical cohort.
4. Reoperation rate at 1 year compared to historical cohort.
5. Hospital admission rate compared to the historical cohort.
6. Assessment of change in quality of life: specific quality of life assessment survey at one month and one year after treatment with respect to baseline. A 10% change in quality of life scores is considered clinically relevant.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Grupo Dermatologico Y Estetico Pedro Jaen S.A.

Sponsor organisation

Grupo Dermatologico Y Estetico Pedro Jaen S.A.

Address

Calle De Serrano 143

City

Madrid

Postcode

28006

Country

Spain

Scientific contact point

Organisation

Grupo Dermatologico Y Estetico Pedro Jaen S.A.

Contact name

Luis Riera del Moral

Public contact point

Organisation

Grupo Dermatologico Y Estetico Pedro Jaen S.A.

Contact name

Luis Riera del Moral

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

2 submissions — initial application plus substantial / non-substantial modifications