- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06174597
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
Recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
40
Phase
- 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
- Name: Min Zhou, Dr.
- Phone Number: 13951937586
- Email: zhouminnju@126.com
Study Contact Backup
- Name: Lijun Ding
- Phone Number: 86-25-8310-7170
- Email: xmljding@163.com
Study Locations
-
-
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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Aged between 18 and 80, of any gender;
- 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;
- 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;
- Patient experiences rest pain in the limb due to ischemia for at least two weeks;
- Inoperable or not suitable for endovascular treatment,or no obvious improvement after surgical treatment;
- Expected lifespan >2 years;
- Good compliance, accepting dietary control and medication treatment, with an informed consent form signed by the patient themselves or their legal representatives.
Exclusion Criteria:
- 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;
- 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;
- Stenosis of ≥75% in the main-iliac artery;
- Diabetic patients with HbA1c > 10%;
- 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;
- 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;
- 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;
- Congenital or acquired immunodeficiency;
- Pregnant women or those planning pregnancy;
- 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;
- 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 |
Intervention / Treatment |
---|---|
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)
|
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)
|
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
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
hindlimb flow index
Time Frame: 24 months
|
measured by Laser Doppler
|
24 months
|
Secondary Outcome Measures
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
Investigators
- 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)
June 30, 2023
Primary Completion (Estimated)
June 30, 2024
Study Completion (Estimated)
June 30, 2026
Study Registration Dates
First Submitted
July 19, 2023
First Submitted That Met QC Criteria
December 7, 2023
First Posted (Actual)
December 18, 2023
Study Record Updates
Last Update Posted (Actual)
December 18, 2023
Last Update Submitted That Met QC Criteria
December 7, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Critical Limb Ischemia
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-
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-
University Health Network, TorontoUnknown
-
Changi General HospitalCompletedCritical Limb IschemiaSingapore
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AnGes USA, Inc.TerminatedCritical Limb IschemiaUnited States, France, Belgium, Canada, Poland, Finland, Denmark, Netherlands, Hungary, Italy, Sweden
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R-BioPusan National University HospitalCompletedCritical Limb IschemiaKorea, Republic of
-
Pharmicell Co., Ltd.Withdrawn
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Lifecells, LLC.CompletedCritical Limb IschemiaUnited States
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Neuromed IRCCSUnknown
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