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

December 1, 2014 updated by: Xiaobing Fu, Chinese PLA General Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100039
        • Recruiting
        • Chinese PLA General Hospital
        • Contact:
          • haojie Hao
          • Phone Number: +86(10)937516
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of Adverse Events
Time Frame: 6 months
Frequency and severity of Adverse Events
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Relative Wound Area Regression of 40% or More at 6 Week
Time Frame: 6 week
6 week

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduced pain
Time Frame: 6 months after treatment
Reduced pain, measured by VAS scale and use of analgesics
6 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

November 12, 2014

First Submitted That Met QC Criteria

December 1, 2014

First Posted (Estimate)

December 2, 2014

Study Record Updates

Last Update Posted (Estimate)

December 2, 2014

Last Update Submitted That Met QC Criteria

December 1, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHIN-PLAGH-ST-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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