Infusion of endothelial progenitor cells for patients with critical limb ischemia

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

This study is testing if giving special cells through an IV can help people with critical limb ischemia, who have severe leg pain or ulcers and can't have regular surgeries, feel better and heal.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 27 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Allife Medical Science and Technology Co., Ltd. (industry)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06359912 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and preliminary efficacy of intravenous infusion of allogeneic endothelial progenitor cells (EPCs) in patients suffering from critical limb ischemia (CLI) who are not candidates for traditional revascularization therapies. The study focuses on patients with severe leg pain, ulcers, or gangrene due to poor blood flow. The primary goal is to assess the safety of the treatment, while secondary goals include measuring improvements in leg pain, blood flow, and wound healing. Participants will be monitored for adverse events and clinical outcomes following the EPC infusion.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with critical limb ischemia who have not responded to traditional therapies and have significant arterial blockage.

Not a fit: Patients with CLI who are eligible for traditional revascularization therapies or have advanced skin ulcers beyond Wagner grade 4 may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients with critical limb ischemia, potentially improving their quality of life and reducing the need for amputations.

How similar studies have performed: While the use of endothelial progenitor cells is a novel approach in this context, similar studies have shown promise in other vascular conditions, indicating potential for success.

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:

* 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

Where this trial is running

Beijing, Beijing

• Hui Shi — Beijing, Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Shaoying Lu, Dr

Conditions: Critical Limb Ischemia, Leg Pain, Ulcer, iscemia, Peripheral Vascular Diseases