Umbilical Cord Artery-derived Perivascular Stem Cells for the Critical Limb Ischemia Therapy

December 7, 2023 updated by: Li-jun Ding, Nanjing University

Efficacy and Safety of Umbilical Cord Artery-derived Perivascular Stem Cells in Patients With Critical Limb Ischemia

This clinical trial included 2 periods. During the first period, it was a single arm study to explore the safety of umbilical cord artery-derived stem cells (UCA-PSCs) in the treatment of patients with critical limb ischemia (CLI). During the second perid, it was a single-center, randomized, controlled prospective study to determine the efficacy of the UCA-PSCs treatment. Those who had CLI were enrolled in the study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

According to the enrollment and exclusion criteria, the patients were enrolled.During the first period, 10 patients were injected with UCA-PSCs/bFGF, a second injection was given 8 weeks later. During the second period, the patients were randomly divided into two groups by computer randomization.Group A was the UCA-PSCs/bFGF group (test group). Group B was the bFGF group (control group).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • The affiliated Drum Towel Hospital of Nanjing University Medical School
        • Contact:
          • Min Zhou, phD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged between 18 and 80, of any gender;
  2. Diagnosed with lower extremities ischemia, classified as Rutherford Stage IV-V, affecting at least one limb. If both lower limbs have ischemic disease, the researcher will determine which affected limb will be studied. The resting ankle systolic pressure (dorsalis pedis artery or posterior tibial artery) of the affected limb is less than 60mmHg, or the toe systolic pressure is less than 40 mmHg, or the Ankle-Brachial Index (ABI) is less than 0.50;
  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 ≥75% or occlusion;
  4. Patient experiences rest pain in the limb due to ischemia for at least two weeks;
  5. Inoperable or not suitable for endovascular treatment，or no obvious improvement after surgical treatment;
  6. Expected lifespan >2 years;
  7. Good compliance, accepting dietary control and medication treatment, with an informed consent form signed by the patient themselves or their legal representatives.

Exclusion Criteria:

  1. Acute ischemic disease of the lower limb(s) occurred within the past 2 weeks, or patients with acute progression of lower extremity arterial ischemic disease, or those with local/diffuse gangrene;
  2. Unsatisfactory evaluation of condition stability after vascular reconstruction surgery or sympathetic nerve removal surgery performed within 4 weeks，or possibility of undergoing amputation in the next 4 weeks;
  3. Stenosis of ≥75% in the main-iliac artery;
  4. Diabetic patients with HbA1c > 10%;
  5. Abnormal laboratory test results that meet any of the following criteria:i. Abnormal blood routine examination: Hemoglobin (HGB)<80 g/L, or white blood cell count (WBC)<3.0×10^9/L, or platelet count (PLT)<50×10^9/L; ii. Abnormal liver function: Aspartate aminotransferase (AST)>2 times the upper limit of normal (ULN), or alanine aminotransferase (ALT)>2×ULN, total bilirubin (TBIL)>2×ULN; iii. Severe renal dysfunction requiring dialysis treatment;iv. Other abnormal laboratory testing indicators that researchers believe may affect the evaluation of trial results;
  6. Diseases unsuitable for clinical trials, or contraindications to surgery: i. Difficult-to-control hypertension (>180/110mmHg), severe heart failure (NYHA IV), or EF<30%;ii. Patients who have had a stroke, brain hemorrhage, myocardial infarction, or unstable angina in the past one month; iii. Patients with malignant tumors;iv. Receiving immunosuppressants, hemodialysis, chemotherapy, and radiotherapy; v. Active infection, HIV antibody positive, Hepatitis C antibody positive, Hepatitis B (HBsAg positive and Hepatitis B virus DNA quantitative detection value greater than 1×10^3 IU/mL); vi. Serious infections (like cellulitis, osteomyelitis etc.) in the observational limb, exposure of distal fascia or skeleton, unable to maintain wound care for ulcers in the surgical area etc.; vii. History of major surgery or serious injury within the last one months;
  7. During the trial, taking the following drugs at doses greater than stated below, except those who stop medication or adjust the dose to the prescribed dose for 7 days according to the washout period: i. COX-2 inhibitor drugs (such as nimesulide); ii. Aspirin (more than 100 mg/day);iii. High-dose steroid medications, excluding inhaled steroids; iv. Opioid analgesics (like morphine) for 2 weeks or longer;
  8. Congenital or acquired immunodeficiency;
  9. Pregnant women or those planning pregnancy;
  10. Diseases like pulmonary heart disease and mental illness that researchers believe are unstable and cannot complete the trial, or comorbidities that could interfere with safety checks and effectiveness assessments;
  11. Currently participating in other clinical trials.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: UCA-PSCs/bFGF group
Clusters of umbilical cord artery-derived perivascular stem cells (Dose: 1.2 x 10^8 cells+20ng bFGF /20mL/vial)
Procedure: UCA-PSCs/bFGF or bFGF Intramuscular injection
After skin disinfection, according to the distribution characteristics of blood vessels around the vascular lesion area, the site that is most likely to establish a new collateral circulation in vascular anatomy is selected. According to the vascular lesion of each subject, 40 reasonable injection sites are selected for Clusters of umbilical cord artery-derived perivascular stem cells with bFGF or bFGF only.
Active Comparator: bFGF group
(Dose: 20ng bFGF /20 mL/vial)
Procedure: UCA-PSCs/bFGF or bFGF Intramuscular injection
After skin disinfection, according to the distribution characteristics of blood vessels around the vascular lesion area, the site that is most likely to establish a new collateral circulation in vascular anatomy is selected. According to the vascular lesion of each subject, 40 reasonable injection sites are selected for Clusters of umbilical cord artery-derived perivascular stem cells with bFGF or bFGF only.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
hindlimb flow index
Time Frame: 24 months
measured by Laser Doppler
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Increase in transcutaneous partial oxygen pressure (TcPO2)
Time Frame: 24 months
measured by Doppler
24 months
Ankle brachial pressure index (ABPI)
Time Frame: 24 months
measured by Doppler
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanjing University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Haiming Xia, phD, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLI-2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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