Safety and Efficacy of Allogeneic MSCs in Promoting T-regulatory Cells in Patients With Small Abdominal Aortic Aneurysms

• Status: Terminated
• Trial end date: 2021-09-30
• Target enrollment: 0
• Participant gender: All

Summary

This project is to determine the safety and explore the effectiveness of allogeneic (not cells of the participant but those of another human) mesenchymal stromal cells (MSCs) in decreasing inflammation and possible enlargement of the participants' abdominal aortic aneurysm. Participants will be selected as a possible subject because of an abdominal aortic aneurysm discovered on the ultrasound or computed tomographic ("CT") scan requested by the participants' doctor.

The purpose of this study is to collect information that will be used to determine if MSCs can be used to decrease inflammation and possibly slow down enlargement of the participants' aneurysm. The investigators will also be collecting blood samples to study special inflammatory cells that cause aneurysms as well as asking participants to have a "PET" (positron emission tomography) scan that can measure inflammation directly in the participants' aneurysm.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development

Criteria

Inclusion Criteria:

• Be 40 and 85 years of age.

• Have diagnosis of noninflammatory degenerative infrarenal abdominal aortic aneurysms measuring 3-5 cm. in diameter by Computed Tomography (CT) scan.

• Females of childbearing potential must be willing to use one form of birth control for the duration of the study. Female participants must undergo a blood or urine pregnancy test at screening.

Exclusion Criteria:

• Inflammatory AAA defined by a thickened aortic wall and retroperitoneal fibrosis and adhesions of peritoneal organs, and elevated erythrocyte sedimentation rate or in the opinion of investigator.

• Mycotic AAA defined as saccular morphology, a positive blood culture, fever, or in the opinion of the investigator.

• Symptomatic, Saccular, or any AAA associated with thoracic aorta dilatation >5.0 cm.

• Infra-renal AAA associated with Marfan's or Ehlers-Danlos Syndrome or other connective tissue disorders.

• Common or external iliac artery aneurysm > 30 cm. in maximal transverse diameter.

• AAA due to dissection.

• Allergy to iodine contrast.

• History of cancer within the last 5 years, except basal cell skin carcinoma with clean border pathology report.

• eGFR< 30mL/min.

• Any condition requiring immunosuppressant medications (e.g., for treatment of organ transplants, psoriasis, Crohn's disease, alopecia areata, rheumatoid arthritis, scleroderma, lupus).

• Acute coronary syndrome in the last 30 days prior to enrollment.*

• CHF hospitalization within the last 30 days prior to enrollment.*

• HIV or HCV positive.

• Contraindication to Computed Tomography or known allergy to contrast media.

• Any bleeding diathesis defined as an INR 2.0 (off anticoagulation therapy) or history of platelet count less than 70,000 or hemophilia.

• Pregnant or breast feeding women.

• Significant hepatic dysfunction (ALT or AST greater than 2 times normal).

• Life expectancy less than two years.

• Inability to provide written informed consent due to cognitive or language barriers (interpreter permitted).

• Presence of any clinical condition that in the opinion of the PI or the sponsor makes the patient not suitable to participate in the trial.

• As defined by the standard definitions of CHF and ACS by the American Heart Association.