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

Phase 1

• Conditions: Peripheral Vascular Disease; Diabetic Foot; Ischemia
• Interventions: Biological: mesenchymal stem cells; Biological: saline

• Registration Number: NCT02796079
• Lead Sponsor: Jie Shen

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2015-01
• Study First Submitted: 2016-05-30
• Study First Submitted QC: 2016-06-06
• Study First Posted: 2016-06-10
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-06
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Autologous Bone Marrow Stem Cell	mesenchymal stem cells	Mesenchymal stem cells derived from bone marrow infusion
saline	saline	saline injections

Primary Outcome Measures

Name	Time	Method
Area of diabetic foot ulcers	3 months	To determine the ability of MSC to facilitate and accelerate diabetic foot ulcers healing.

Secondary Outcome Measures

Name	Time	Method
Improvement of transcutaneous oxygen partial pressure (TcPO2)	3 months	Improvement of local perfusion.
Improvement of microvascular cutaneous reactivity by laser Doppler perfusion monitoring (LDPM)	3 months
Pain (Visual-Analog Scale)	3 months	Measure of the subjective symptom of pain.
Walking distance (treadmill) if possible	3 months

Trial Locations

Locations (1)

the Third Affiliated Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China