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

NCT06359912 | Recruiting Phase 1 DMC

• 1 other identifier: CNYX-EPCs-002-1
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Limb Ischemia

Keywords

Leg Pain; Ulcer; iscemia; Peripheral Vascular Diseases

Outcome Measures

Primary Outcomes (1)

• adverse events

  Incidence and severity of adverse events assessed by CTCAE V5.0

  baseline to 1 year

Secondary Outcomes (5)

• Painless walking and intermittent claudication distance

  month 6

• Blood flow of the affected limb

  month 6

• Rutherford grade

  month 6

• The area of skin ulcer

  month 6

• Vascular Quality of Life Questionnaire-6 score

  month 6

Study Arms (2)

Treatment (clinical standard treatment, EPCs)

EXPERIMENTAL

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

Drug: EPCs; Behavioral: Clinical standard treatment (CST)

clinical standard treatment

OTHER

Patients receive clinical standard treatment

Behavioral: Clinical standard treatment (CST)

Interventions

EPCs DRUG

IV

Also known as: iPSC EPCs

Treatment (clinical standard treatment, EPCs)

Clinical standard treatment (CST) BEHAVIORAL

Clinical standard treatment

Also known as: CST

Treatment (clinical standard treatment, EPCs); clinical standard treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age is between 18 and 80.
• 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;
• 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;
• The degree of skin ulcer is determined according to Wagner, grade less than or equal to 4;
• Resting pain lasted for more than 2 weeks when signing the informed consent form
• Eligible patients of childbearing potential (both men and women) if sexually active must agree to use a reliable method of contraception with their partners
• The subject or agent can understand the basic requirements of the study, provide written informed consent, and follow up according to the trial requirements.

You may not qualify if:

• Subjects who have received other cell therapies previously
• Subjects who have received or are attending any other unlisted clinical study drug or treatment within 4 weeks prior to the first dose;
• Stenosis of ≥75% in the main-iliac artery;
• Subjects whose Feet or lower limb infections are uncontrollable, or other uncontrolled active infections;
• Patients with diabetic proliferating retinopathy (diabetic retinopathy grade 4 according to the International Clinical Classification Standard for diabetic retinopathy)
• Acute ischemic disease of the lower limb(s) occurred within the past 2 weeks;
• presence of uncontrolled hypertension;
• Any one with cerebral infarction, cerebral hemorrhage, heart failure, unstable angina pectoris, acute myocardial infarction, or severe arrhythmia before enrollment;
• abnormal Laboratory tests including severe liver, kidney and coagulation disorders, severe anemia etc.
• Patients with severe respiratory disease and other active lung infections requiring intervention that were not eligible for participation in the study
• Hepatitis B surface antigen positive, hepatitis C virus antibody positive, syphilis serum antibody positive or HIV antibody positive
• Patients with malignancy within the 5 years prior to screening (except for cured basal cell skin carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma)
• Patients with mental illness, cognitive impairment, except those cured of depression; estimated survival of less than 12 months
• Congenital or acquired immunodeficiency;
• Subjects with Pregnant or lactating subjects

Sponsors & Collaborators

• Allife Medical Science and Technology Co., Ltd.: lead
• First Affiliated Hospital Xi'an Jiaotong University: collaborator

Study Sites (1)

Hui Shi

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Ulcer; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Central Study Contacts

Shaoying Lu, Dr

CONTACT

029-85323473; xjyfyllh@163.com

Fanggang Li

CONTACT

86-18911352611; lifanggang@allifetech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 11, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: July 1, 2025
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)