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

Diabetic Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02796079
• Other study ID #: ThirdSouthernMedical
• Status: Recruiting
• Phase: Phase 1
• First received: May 30, 2016
• Last updated: April 4, 2017
• Start date: January 2015
• Est. completion date: December 2018

Study information

• Verified date: April 2017
• Source: The Third Affiliated Hospital of Southern Medical University
• Contact: Jie Shen
• Phone: +86 13808893818
• Email: shenjiedr[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Biological:
• mesenchymal stem cells
stem cell acquisition, processing and reinfection, to evaluate the efficacy by using autologous bone marrow stem cell
• saline
saline injections

Locations

Country	Name	City	State
China	the Third Affiliated Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (5)

Lead Sponsor	Collaborator
Jie Shen	Academy Military Medical Science, China, Nanfang Hospital of Southern Medical University, Southern Medical University, China, The Fifth Affiliated Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area of diabetic foot ulcers	To determine the ability of MSC to facilitate and accelerate diabetic foot ulcers healing.	3 months
Secondary	Improvement of transcutaneous oxygen partial pressure (TcPO2)	Improvement of local perfusion.	3 months
Secondary	Improvement of microvascular cutaneous reactivity by laser Doppler perfusion monitoring (LDPM)		3 months
Secondary	Pain (Visual-Analog Scale)	Measure of the subjective symptom of pain.	3 months
Secondary	Walking distance (treadmill) if possible		3 months