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

Diabetic Foot Clinical Trial

Official title:

Vascular Occlusive Diseases Such as Diabetic Foot Treated With Mesenchymal Stem Cell

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02304588
• Other study ID #: CHIN-PLAGH-ST-001
• Status: Recruiting
• Phase: Phase 1
• First received: November 12, 2014
• Last updated: December 1, 2014
• Start date: January 2013
• Est. completion date: December 2017

Study information

• Verified date: November 2014
• Source: Chinese PLA General Hospital
• Contact: xiaobing FU
• Phone: +86(10)937516
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 78 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Lower Limb Ischemia

Intervention

Biological:
• Mesenchymal stem cells
10-20 x 10^6 cells/20mL

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reduced pain	Reduced pain, measured by VAS scale and use of analgesics	6 months after treatment	Yes
Primary	Frequency of Adverse Events	Frequency and severity of Adverse Events	6 months	Yes
Secondary	Relative Wound Area Regression of 40% or More at 6 Week		6 week	Yes