Safety and Preliminary Efficacy of Allogeneic Endothelial Progenitor Cells (EPCs) in Patients With Critical Limb Ischemia

NCT ID: NCT06359912

Last Updated: 2024-04-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2025-07-31

Brief Summary

The purpose of this study is to determine if allogeneic Endothelial Progenitor Cells (EPCs) intravenous infusion to a subject with leg ulcer and/or gangrene due to poor blood flow will be safe and if it will relieve leg pain, increase blood flow, and/or cure the leg wound.

Detailed Description

Critical limb ischemia (CLI) is a progressive disease, which arises as a result of atherosclerosis or vasculitis in leg arteries. Prognosis of CLI is poor, and no effective treatments have been established in patients who are not eligible for the traditional revascularization therapies such as angioplasty and bypass procedures due to the inappropriate anatomy of the leg arteries or frequent reocclusion following revascularization. Therefore, it is necessary to establish novel revascularization treatment to improve prognosis of the no-option patients. The investigators will study the safety and clinical efficiency of vascular regeneration by means of transplantation of allogeneic Endothelial Progenitor Cells in patients with CLI who are not eligible for traditional revascularization treatments. The primary endpoint is the safety and tolerance identified by adverse events related with investigated drug；while the secondary endpoints are evaluation of the preliminary efficacy of EPCs.

Conditions

Critical Limb Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (clinical standard treatment, EPCs)

Patients receive clinical standard treatment and EPCs IV with a single dose

Group Type: EXPERIMENTAL

EPCs

Intervention Type: DRUG

IV

Clinical standard treatment (CST)

Intervention Type: BEHAVIORAL

Clinical standard treatment

clinical standard treatment

Patients receive clinical standard treatment

Group Type: OTHER

Clinical standard treatment (CST)

Intervention Type: BEHAVIORAL

Clinical standard treatment

Interventions

EPCs

IV

Intervention Type: DRUG

Clinical standard treatment (CST)

Clinical standard treatment

Intervention Type: BEHAVIORAL

Other Intervention Names

iPSC EPCs; CST

Eligibility Criteria

Inclusion Criteria

• CLI patients fulfilling all the following criteria are considered suitable for inclusion in the study.

1. Age is between 18 and 80.

2. Diagnosis of critical limb ischemia, no surgery or interventional therapy, or poor results one month after interventional therapy (no relief of symptoms), Rutherford grade 3, grade 4 or grade 5, while meeting one of the following criteria: 1) severe intermittent claudication; 2) resting pain; 3) ABI≤ 0.60;

3. Within the last month, Digital Subtraction Angiography (DSA), Computed Tomography Arteriography (CTA), Magnetic Resonance Angiography (MRA)，or vascular ultrasound has confirmed that one or more of the arteries (superficial femoral artery, i.e., the femoral artery below the deep femoral artery branch, the popliteal artery, and its following arteries) have a stenosis of ≥70% or occlusion;

4. The degree of skin ulcer is determined according to Wagner, grade less than or equal to 4;

5. Resting pain lasted for more than 2 weeks when signing the informed consent form

6. Eligible patients of childbearing potential (both men and women) if sexually active must agree to use a reliable method of contraception with their partners

7. The subject or agent can understand the basic requirements of the study, provide written informed consent, and follow up according to the trial requirements.

Exclusion Criteria

1. Subjects who have received other cell therapies previously

2. Subjects who have received or are attending any other unlisted clinical study drug or treatment within 4 weeks prior to the first dose;

3. Stenosis of ≥75% in the main-iliac artery;

4. Subjects whose Feet or lower limb infections are uncontrollable, or other uncontrolled active infections;

5. Patients with diabetic proliferating retinopathy (diabetic retinopathy grade 4 according to the International Clinical Classification Standard for diabetic retinopathy)

6. Acute ischemic disease of the lower limb(s) occurred within the past 2 weeks;

7. presence of uncontrolled hypertension;

8. Any one with cerebral infarction, cerebral hemorrhage, heart failure, unstable angina pectoris, acute myocardial infarction, or severe arrhythmia before enrollment;

9. abnormal Laboratory tests including severe liver, kidney and coagulation disorders, severe anemia etc.

10. Patients with severe respiratory disease and other active lung infections requiring intervention that were not eligible for participation in the study

11. Hepatitis B surface antigen positive, hepatitis C virus antibody positive, syphilis serum antibody positive or HIV antibody positive

12. Patients with malignancy within the 5 years prior to screening (except for cured basal cell skin carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma)

13. Patients with mental illness, cognitive impairment, except those cured of depression; estimated survival of less than 12 months

14. Congenital or acquired immunodeficiency;

15. Subjects with Pregnant or lactating subjects

16. Subjects with known allergy to more than 2 drugs

17. Current or recent history of alcohol or drug abuse

18. Patients not eligible for enrollment as comprehensively assessed by the investigator

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: collaborator

Allife Medical Science and Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hui Shi

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shaoying Lu, Dr

Role: CONTACT

xjyfyllh@163.com

029-85323473 ext. 029-85323473

Fanggang Li

Role: CONTACT

lifanggang@allifetech.com

86-18911352611

Facility Contacts

Shaoying Lu, Dr

Role: primary

xjyfyllh@163.com

+862985323473 ext. +862985323473

Fanggang Li

Role: backup

lifanggang@allifetech.com

86-18911352611

Other Identifiers

CNYX-EPCs-002-1

Identifier Type: -

Identifier Source: org_study_id