Critical limb ischemia
Conditions
Interventions
Treatment:Conventional standard therapy and intramuscular injection of autologous adipose-derived stem/stromal cells
Control:Conventional standard therapy1
Sponsors
Renmin Hospital, Hubei University of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18 to 75 years; 2. Established CLI (ASO, TAP, diabetic foot) at least 6 months since the onset, clinically and hemodynamically confirmed as per Rutherford- II-4, III-5, or III-6; limb diastolic pressure = 75% blockage or stenosis; 4. Patients if having associated Type II Diabetes, should be on medication and well controlled (HbA1c =4 (if patient is taking pain reliever, stop medication for 3 days prior to VAS rating); 7. If there is ulceration, debridement is needed prior to study; 8. Subject must have negative tumor testing results at least 3 months prior to start of clinical trial: 9. Menopausal female patients or received hysterectomy, premenopausal female-negative beta hcg; 10. Patients who can give informed consent themselves in writing.
Exclusion criteria
Exclusion criteria: 1. Vascular or neurosurgery within the past 12 weeks except failed vascular surgery within 4 weeks; 2. Limb ischemia of unknown cause or Life-threatening complications of limb ischemia necessitating immediate amputation; 3. Possible amputation within the next 4 weeks or internal iliac artery >=75% stenosis; 4. Type I Diabetes; 5. Cirrhosis, jaundice, ascites, GI bleed, severe hepatitis; 6. NYHA class III or IV; 7. Stroke, brain bleed, myocardial infarction, unstable angina within the past 3 months; 8. Current malignancy or history of previous malignancy; 9. Treatment with immunosuppressant drugs, plasma exchange, radiation and chemotherapy; 10. Hypertensive patients with systolic blood pressure >160 mmhg, diastolic blood pressure >100 mmhg; 11. Patients tested positive for HIV 1, hepatitis C virus (HCV), hepatitis B virus (HBV), tested with HBsAg: DNA level>1x10^3IU/mL; 12. Active clinical infection within one week of enrollment; 13. Life expectancy < 6 months; 14. Subject not eligible for syringe-based lipoharvest of at least 200cc of subcutaneous adipose tissue.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse effects;The percentage of Wound closure;Wound Dimension Decreases; | — |
Secondary
| Measure | Time frame |
|---|---|
| pain;SF-36;Change in Gene Expression Analysis/ Change in Bacterial Counts; | — |
Countries
China
Contacts
Public ContactBin Zhou
Renmin Hospital, Hubei University of Medicine
Outcome results
None listed