Diabetic Foot, Gangrene, Ischemia, Leg Ulcer, Peripheral Vascular Disease
Conditions
Brief summary
The intent of this clinical study is to evaluate the safety of the injection composed of autologous bone marrow derived endothelial cells (BM-ECs) and platelet-rich plasma extract (PRPE) for the treatment of critical limb ischemia.
Interventions
BIOLOGICALBM-ECs and PRPE
BIOLOGICALBM-ECs
Sponsors
South China Research Center for Stem Cell and Regenerative Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Limb ischemia patients(e.g. arteriosclerosis obliterans,diabetic critical limb ischemia, thromboangitis obliterans) 1. 18 Years to 80 Years (Adult, Senior); 2. Have ability to understand and comply with the study requirements, and provide the written informed consent prior to any procedures ; 3. Patient meets at least one of the following diagnostic criteria for the index limb: 1. ABI\<0.7mmHg 2. TcpO2 \<40 mm Hg 3. Or, nonhealing ulcer due to local arterial compromise with no opportunity for revascularization; 4. Have no improvement after conservative treatment and are not suitable for surgical bypass surgery because no outflow tract of diseased vessel can be found by imaging; 5. Despite having good outflow artery, but the elderly and frail patients can also not tolerate revascularization or interventional surgery; 6. Unlikelihood of major amputation of the leg during the next 12 months; 7. Expected life span more than 2 years.
Exclusion criteria
1. Pregnant or lactating; 2. Diabetics with poorly controlled blood glucose levels (defined as HbA1c\>7% and/or proliferative retinopathy); 3. Patients with decompensated cardiac, renal or liver disease; 4. Patients with confirmed malignant tumor; 5. Subjects are with serious heart, liver, kidney and lung failure or under poor general condition that are inability to undergo bone marrow harvesting and transplantation; 6. Known or suspected disease of the immune system or osteomyelitis; 7. Inability to sign informed consent form and to comply with the schedule of the study; 8. There has reason to suspect that the patient is forced to join the study; 9. Any other condition, in the opinion of the investigator, would render the patient unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival without major amputation | 6 months after implantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perfusion rate in treated tissue by transcutaneous PO2 (TcPO2) | Within 6 months after implantation | — |
| Perfusion rate in treated tissue by digital subtraction angiography (DSA) | Within 6 months after implantation | — |
| wound size | Within 6 months after implantation | — |
| Perfusion rate in treated tissue by measure of ankle-brachial index (ABI) | Within 6 months after implantation | — |
| Pain intensity | Within 6 months after implantation | Pain intensity using Visual Analogue Scale |
| Thermography | Within 6 months after implantation | — |
| wound stage | Within 6 months after implantation | — |
Contacts
Primary ContactXuetao Pei, M.D., Ph.D
Backup ContactFang Fang, Ph.D
Outcome results
None listed