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

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.

Study Overview

• Status: Unknown
• Conditions: Ischemia; Diabetic Foot; Leg Ulcer; Peripheral Vascular Disease; Gangrene
• Intervention / Treatment: Biological: BM-ECs and PRPE; Biological: BM-ECs

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Biological: BM-ECs and PRPE
Active Comparator: BM-ECs; Intramuscular injection of bone marrow derived endothelial cells only.	Biological: BM-ECs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Survival without major amputation	6 months after implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perfusion rate in treated tissue by measure of ankle-brachial index (ABI)		Within 6 months after implantation
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
wound stage		Within 6 months after implantation
Pain intensity	Pain intensity using Visual Analogue Scale	Within 6 months after implantation
Thermography		Within 6 months after implantation

Collaborators and Investigators

• Sponsor: South China Research Center for Stem Cell and Regenerative Medicine

Study record dates

Study Major Dates

• Study Start: March 1, 2018
• Primary Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: November 23, 2016
• First Submitted That Met QC Criteria: December 13, 2016
• First Posted (Estimate): December 15, 2016

Study Record Updates

• Last Update Posted (Estimate): December 15, 2016
• Last Update Submitted That Met QC Criteria: December 13, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Skin Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Endocrine System Diseases; Diabetic Angiopathies; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Atherosclerosis; Foot Ulcer; Diabetic Foot; Vascular Diseases; Ischemia; Peripheral Arterial Disease; Peripheral Vascular Diseases; Leg Ulcer; Gangrene
• Other Study ID Numbers: BMEC-PRPE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes