Stem Cell Therapy for Patients With Vascular Occlusive Diseases Such as Diabetic Foot

Phase 1

• Conditions: Diabetic Foot; Lower Limb Ischemia
• Interventions: Biological: Mesenchymal stem cells

• Registration Number: NCT02304588
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

Mesenchymal stem cells with multidirectional differentiation potential,autologous stem cell transplantation into ischemic foot, make its differentiation to form new blood capillary, improve and restore the local blood flow.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Status Verified: 2014-11
• Study First Submitted: 2014-11-12
• Study First Submitted QC: 2014-12-01
• Last Update Submitted: 2014-12-01
• Study First Posted: 2014-12-02
• Last Update Posted: 2014-12-02
• Primary Completion: 2015-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• the age of 30-78 years old, men and women there is no limit.
• in accordance with the ministry of health in higher medical colleges and universities teaching material the sixth edition of the annals of diabetic foot diagnostic criteria.
• with severe lower limb ischemia (defined as the resting state of ankle brachial index (ABI) 0.4-0.85, accompanied by resting or intermittent toe line.
• treatment on a voluntary basis, and sign the informed consent.

Exclusion Criteria

• with severe heart, liver, kidney, lung function failure or general condition is very poor can't tolerate the stem cell transplant.
• clear over the past five years tumor markers in patients with malignant disease and blood levels increased significantly.
• the prodrome of acute infectious diseases.
• participated in clinical subjects within three months before test.
• adherence is poor, can not complete the course.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mesenchymal stem cells	Mesenchymal stem cells	Maximal amount of MSC cells injected: 10-20\*10\^6 cells (up to volume of 20mL, depending on the wound size \& patient weight).

Primary Outcome Measures

Name	Time	Method
Frequency of Adverse Events	6 months	Frequency and severity of Adverse Events

Secondary Outcome Measures

Name	Time	Method
Relative Wound Area Regression of 40% or More at 6 Week	6 week

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China