Actively Recruiting
Umbilical Cord Artery-derived Perivascular Stem Cells for the Critical Limb Ischemia Therapy
Led by Nanjing University · Updated on 2023-12-18
40
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Umbilical Cord Artery-derived Perivascular Stem Cells for the Critical Limb Ischemia Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 80, of any gender
- Diagnosed with lower extremities ischemia, Rutherford Stage IV-V, affecting at least one limb
- Resting ankle systolic pressure of affected limb less than 60 mmHg, or toe systolic pressure less than 40 mmHg, or Ankle-Brachial Index less than 0.50
- Confirmed stenosis of 75% or more or occlusion in key leg arteries by imaging within the last month
- Experiencing rest pain in the limb due to ischemia for at least two weeks
- Inoperable or unsuitable for endovascular treatment, or no improvement after surgery
- Expected lifespan greater than 2 years
- Good compliance and willing to accept dietary control and medication treatment with signed informed consent
You will not qualify if you...
- Acute ischemic disease of the lower limb(s) within the past 2 weeks or acute progression of ischemic disease
- Local or diffuse gangrene
- Unsatisfactory condition stability after vascular reconstruction or sympathetic nerve surgery within 4 weeks
- Possible amputation planned within 4 weeks
- Stenosis of 75% or more in the main iliac artery
- Diabetic patients with HbA1c greater than 10%
- Abnormal lab results including low hemoglobin, white blood cell count, or platelets
- Abnormal liver function tests exceeding twice the normal limit
- Severe kidney dysfunction requiring dialysis
- Other abnormal labs judged by researchers to affect trial evaluation
- Uncontrolled hypertension over 180/110 mmHg
- Severe heart failure (NYHA IV) or ejection fraction below 30%
- Recent stroke, brain hemorrhage, heart attack, or unstable angina within 1 month
- Malignant tumors
- Receiving immunosuppressants, hemodialysis, chemotherapy, or radiotherapy
- Active infections including HIV, Hepatitis B or C
- Serious infections in the limb, exposure of fascia or skeleton, or inability to maintain wound care
- Major surgery or serious injury within the last month
- Use of certain drugs above specified doses without appropriate washout
- Congenital or acquired immunodeficiency
- Pregnant or planning pregnancy
- Unstable pulmonary heart disease or mental illness preventing trial completion
- Participation in other clinical trials currently
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The affiliated Drum Towel Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008
Actively Recruiting
Research Team
M
Min Zhou, Dr.
CONTACT
L
Lijun Ding
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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