A Clinical Study Using Autologous Bone Marrow Stem Cell for Diabetes Related Vascular Complications

Jie Shen240 enrolled

Overview

Stem cell therapy has been a new and effective therapy in recent years for diabetic foot.This study intends to establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.

Diabetic foot is one of the most serious chronic complications of diabetic patients, and still lacking effective treatments. Stem cell therapy has been a new and effective therapy in recent years for diabetic foot. Combined with the previous studies of our research group, this study intends to transform part of the results of this research, establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

240

Conditions

Peripheral Vascular Disease Ischemia Diabetic Foot

Interventions

mesenchymal stem cellsBIOLOGICAL

stem cell acquisition, processing and reinfection, to evaluate the efficacy by using autologous bone marrow stem cell

salineBIOLOGICAL

saline injections

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diabetes mellitus Type 2 or Type 1 * Age between 18-80 years * Chronic foot ulcer more than 6 weeks * No sufficient response to best standard care delivered for six weeks. * PAD up to Fontaine stage III or IV period * CLI with the ankle brachial index (index ankle-brachial, ABI) \<0.7 and (or) the percutaneous oxygen partial pressure (oxygen tension transcutaneous, TcPO2) \<30mmHg Exclusion Criteria: * HbA1c \>12% * Hemoglobin \<10 mg/dl * Creatinine clearance rate \<30ml/min * Systemic bacterial, viral infections (Mei Du, hepatitis, cytomegalovirus infection, HIV, B19 infection, herpes virus infection) and sepsis * Have accepted the treatment of stem cells or growth factors * Have a history of malignant disease * Pregnancy * Mental illness history * Abnormal coagulation function * Allergic reaction * Severe cardiac insufficiency (III-IV NYHA) * Using vasoactive substances

Locations (1)

the Third Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

Area of diabetic foot ulcers

To determine the ability of MSC to facilitate and accelerate diabetic foot ulcers healing.

Time frame: 3 months

Secondary Outcomes

Improvement of transcutaneous oxygen partial pressure (TcPO2)

Improvement of local perfusion.

Time frame: 3 months

Improvement of microvascular cutaneous reactivity by laser Doppler perfusion monitoring (LDPM)

Time frame: 3 months

Pain (Visual-Analog Scale)

Measure of the subjective symptom of pain.

Time frame: 3 months

Walking distance (treadmill) if possible

Time frame: 3 months

Central Contacts

Jie Shen

CONTACT

+86 13808893818 shenjiedr@163.com

Data from ClinicalTrials.gov

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