Autologous Transplantation of BM-ECs With Platelet-Rich Plasma Extract for the Treatment of Critical Limb Ischemia

Phase 1

• Conditions: Leg Ulcer; Diabetic Foot; Peripheral Vascular Disease; Gangrene; Ischemia
• Interventions: Biological: BM-ECs; Biological: BM-ECs and PRPE

• Registration Number: NCT02993809
• Lead Sponsor: South China Research Center for Stem Cell and Regenerative Medicine

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-09
• Study First Submitted: 2016-11-23
• Study First Submitted QC: 2016-12-13
• Last Update Submitted: 2016-12-13
• Study First Posted: 2016-12-15
• Last Update Posted: 2016-12-15
• Study Start: 2018-03
• Primary Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BM-ECs	BM-ECs	Intramuscular injection of bone marrow derived endothelial cells only.
BM-ECs and PRPE	BM-ECs and PRPE	Multipoint of intramuscular injections into ischemic limbs.Injections composed of bone marrow derived endothelial cells (BM-ECs) and platelet-rich plasma extract (PRPE).

Primary Outcome Measures

Name	Time	Method
Survival without major amputation	6 months after implantation

Secondary Outcome Measures

Name	Time	Method
Perfusion rate in treated tissue by transcutaneous PO2 (TcPO2)	Within 6 months after implantation
wound stage	Within 6 months after implantation
Perfusion rate in treated tissue by measure of ankle-brachial index (ABI)	Within 6 months after implantation
Perfusion rate in treated tissue by digital subtraction angiography (DSA)	Within 6 months after implantation
Pain intensity	Within 6 months after implantation	Pain intensity using Visual Analogue Scale
wound size	Within 6 months after implantation
Thermography	Within 6 months after implantation