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

NCT02993809 | Unknown Phase 1 DMC

• 1 other identifier: BMEC-PRPE
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Leg Ulcer; Diabetic Foot; Gangrene; Peripheral Vascular Disease; Ischemia

Outcome Measures

Primary Outcomes (1)

• Survival without major amputation

  6 months after implantation

Secondary Outcomes (7)

• 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

Study Arms (2)

BM-ECs and PRPE

EXPERIMENTAL

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

BM-ECs

ACTIVE COMPARATOR

Intramuscular injection of bone marrow derived endothelial cells only.

Biological: BM-ECs

Interventions

BM-ECs and PRPE BIOLOGICAL

BM-ECs and PRPE

BM-ECs BIOLOGICAL

BM-ECs

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Limb ischemia patients(e.g. arteriosclerosis obliterans,diabetic critical limb ischemia, thromboangitis obliterans)
• Years to 80 Years (Adult, Senior);
• Have ability to understand and comply with the study requirements, and provide the written informed consent prior to any procedures ;
• Patient meets at least one of the following diagnostic criteria for the index limb:
• ABI\<0.7mmHg
• TcpO2 \<40 mm Hg
• Or, nonhealing ulcer due to local arterial compromise with no opportunity for revascularization;
• 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;
• Despite having good outflow artery, but the elderly and frail patients can also not tolerate revascularization or interventional surgery;
• Unlikelihood of major amputation of the leg during the next 12 months;
• Expected life span more than 2 years.

You may not qualify if:

• Pregnant or lactating;
• Diabetics with poorly controlled blood glucose levels (defined as HbA1c\>7% and/or proliferative retinopathy);
• Patients with decompensated cardiac, renal or liver disease;
• Patients with confirmed malignant tumor;
• 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;
• Known or suspected disease of the immune system or osteomyelitis;
• Inability to sign informed consent form and to comply with the schedule of the study;
• There has reason to suspect that the patient is forced to join the study;
• Any other condition, in the opinion of the investigator, would render the patient unsuitable for the study.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Leg Ulcer; Diabetic Foot; Gangrene; Peripheral Vascular Diseases; Ischemia

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xuetao Pei, M.D., Ph.D

CONTACT

8610-68164807; AMMS0906@163.com

Fang Fang, Ph.D

CONTACT

8620-89199011; fangfang@scrm.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2016
• First Posted: December 15, 2016
• Study Start: March 1, 2018
• Primary Completion: December 1, 2019
• Last Updated: December 15, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share