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

Sponsor

Chinese PLA General Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02304588

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Foot Lower Limb Ischemia	Biological: Mesenchymal stem cells	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2015

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Biological: Mesenchymal stem cells 10-20 x 10^6 cells/20mL

Arm

Intervention/Treatment

Experimental: 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).

Biological: Mesenchymal stem cells

10-20 x 10^6 cells/20mL

Outcome Measures

Primary Outcome Measures

Frequency of Adverse Events [6 months]
Frequency and severity of Adverse Events

Secondary Outcome Measures

Relative Wound Area Regression of 40% or More at 6 Week [6 week]

Other Outcome Measures

Reduced pain [6 months after treatment]
Reduced pain, measured by VAS scale and use of analgesics

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 78 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chinese PLA General Hospital	Beijing	Beijing	China	100039

Sponsors and Collaborators

Chinese PLA General Hospital

Investigators

Principal Investigator: xiaobing FU, Chinese PLA General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xiaobing Fu, Academician, Chinese PLA General Hospital

ClinicalTrials.gov Identifier:

NCT02304588

Other Study ID Numbers:

CHIN-PLAGH-ST-001

First Posted:

Dec 2, 2014

Last Update Posted:

Dec 2, 2014

Last Verified:

Nov 1, 2014

Additional relevant MeSH terms:

Diabetic Foot

Ischemia

Study Results

No Results Posted as of Dec 2, 2014