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

Critical Limb Ischemia Clinical Trial

Official title:

Phase I Clinical Study on the Safety and Preliminary Efficacy of Allogeneic Endothelial Progenitor Cells (EPCs) Injection in Patients With Critical Limb Ischemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06359912
• Other study ID #: CNYX-EPCs-002-1
• Status: Recruiting
• Phase: Phase 1
• Start date: April 2024
• Est. completion date: July 2025

Study information

• Verified date: April 2024
• Source: Allife Medical Science and Technology Co., Ltd.
• Contact: Shaoying Lu, Dr
• Phone: 029-85323473
• Email: xjyfyllh[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: July 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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:

• Any one of the following exclusion criteria is sufficient to disqualify a patient from the study.

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

Related Conditions & MeSH terms

• Chronic Limb-Threatening Ischemia
• Critical Limb Ischemia
• Ischemia

Intervention

Drug:
• EPCs
IV

Behavioral:
• Clinical standard treatment (CST)
Clinical standard treatment

Locations

Country	Name	City	State
China	Hui Shi	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Allife Medical Science and Technology Co., Ltd.	First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adverse events	Incidence and severity of adverse events assessed by CTCAE V5.0	baseline to 1 year
Secondary	Painless walking and intermittent claudication distance	Changes from the baseline of painless walking and intermittent claudication distance by visit	month 6
Secondary	Blood flow of the affected limb	Changes from the baseline of Blood flow of the affected limb by visit	month 6
Secondary	Rutherford grade	Changes from the baseline of Rutherford grade by visit. The range of Rutherford grade is from 0 (normal) to 6 (worse).	month 6
Secondary	The area of skin ulcer	Changes from the baseline of the area of skin ulcer by visit	month 6
Secondary	Vascular Quality of Life Questionnaire-6 score	Changes from the baseline of Vascular Quality of Life Questionnaire-6 score by visit. The range of scores is from 6 (normal) to 24.	month 6