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Critical Limb IschemiaPhase 1NCT06359912

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

A Phase 1 study testing EPCs and Clinical standard treatment (CST) in people with Critical Limb Ischemia, run by Allife Medical Science and Technology Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Critical Limb Ischemia
What is being tested?
EPCs and Clinical standard treatment (CST)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteChina
Study dates
Apr 2024to Jul 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Any one of the following exclusion criteria is sufficient to disqualify a patient from the study.
  • 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)
Show all 19Show fewer
  • 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
  • Subjects with known allergy to more than 2 drugs
  • Current or recent history of alcohol or drug abuse
  • Patients not eligible for enrollment as comprehensively assessed by the investigator

Trial locations and contacts

1 site in 1 country.

Shaoying Lu, Dr contact

029-85323473 ext. 029-85323473

xjyfyllh@163.com

Fanggang Li contact

86-18911352611

lifanggang@allifetech.com

China1 site, 1 recruiting

  • Hui Shi

    Beijing, Beijing Municipality

    Shaoying Lu, Dr, +862985323473 ext. +862985323473, xjyfyllh@163.com

    Fanggang Li, 86-18911352611, lifanggang@allifetech.com

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
EPCs, Clinical standard treatment (CST)
Keywords
Leg Pain, Ulcer, iscemia, Peripheral Vascular Diseases
Medical subject headings
Chronic Limb-Threatening Ischemia, Ulcer, Peripheral Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EPCsDrug

    Also called iPSC EPCs

    IV

  • Clinical standard treatment (CST)Behavioural

    Also called CST

    Clinical standard treatment

Study groups in NCT06359912
Study groupRoleWhat they receive
Treatment (clinical standard treatment, EPCs)ExperimentalPatients receive clinical standard treatment and EPCs IV with a single dose
Receives: Drug: EPCs; Behavioral: Clinical standard treatment (CST)
clinical standard treatmentOtherPatients receive clinical standard treatment
Receives: Behavioral: Clinical standard treatment (CST)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. adverse events

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

    Measured: baseline to 1 year

Secondary outcomes (5)

  1. Painless walking and intermittent claudication distance

    Changes from the baseline of painless walking and intermittent claudication distance by visit

    Measured: month 6

  2. Blood flow of the affected limb

    Changes from the baseline of Blood flow of the affected limb by visit

    Measured: month 6

  3. Rutherford grade

    Changes from the baseline of Rutherford grade by visit. The range of Rutherford grade is from 0 (normal) to 6 (worse).

    Measured: month 6

  4. The area of skin ulcer

    Changes from the baseline of the area of skin ulcer by visit

    Measured: month 6

  5. 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.

    Measured: month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2024
  2. Study startApr 2024 (estimated)
  3. Primary completionApr 2025 (estimated)
  4. Study completionJul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
27 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06359912
Sponsor's protocol ID
CNYX-EPCs-002-1
Status last verified
Apr 2024
First submitted
29 Mar 2024
Last updated
11 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing EPCs and Clinical standard treatment (CST) in people with Critical Limb Ischemia, run by Allife Medical Science and Technology Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shaoying Lu, Dr (029-85323473 ext. 029-85323473, xjyfyllh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

adverse events (time frame: baseline to 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06359912.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.

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