Back to resultsStem Cell Therapy for Patients With Vascular Occlusive Diseases Such as Diabetic Foot
Primary Purpose
Diabetic Foot, Lower Limb Ischemia
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Mesenchymal stem cells
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot
Eligibility Criteria
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.
Sites / Locations
- Chinese PLA General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mesenchymal stem cells
Arm Description
Maximal amount of MSC cells injected: 10-20*10^6 cells (up to volume of 20mL, depending on the wound size & patient weight).
Outcomes
Primary Outcome Measures
Frequency of Adverse Events
Frequency and severity of Adverse Events
Secondary Outcome Measures
Relative Wound Area Regression of 40% or More at 6 Week
Full Information
NCT ID
NCT02304588
First Posted
November 12, 2014
Last Updated
December 1, 2014
Sponsor
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02304588
Brief Title
Stem Cell Therapy for Patients With Vascular Occlusive Diseases Such as Diabetic Foot
Official Title
Vascular Occlusive Diseases Such as Diabetic Foot Treated With Mesenchymal Stem Cell
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot, Lower Limb Ischemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mesenchymal stem cells
Arm Type
Experimental
Arm Description
Maximal amount of MSC cells injected: 10-20*10^6 cells (up to volume of 20mL, depending on the wound size & patient weight).
Intervention Type
Biological
Intervention Name(s)
Mesenchymal stem cells
Intervention Description
10-20 x 10^6 cells/20mL
Primary Outcome Measure Information:
Title
Frequency of Adverse Events
Description
Frequency and severity of Adverse Events
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Relative Wound Area Regression of 40% or More at 6 Week
Time Frame
6 week
Other Pre-specified Outcome Measures:
Title
Reduced pain
Description
Reduced pain, measured by VAS scale and use of analgesics
Time Frame
6 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xiaobing FU
Phone
+86(10)937516
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xiaobing FU
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
haojie Hao
Phone
+86(10)937516
First Name & Middle Initial & Last Name & Degree
haojie Hao
Phone
+86(10)937516
Email
haojieh@163.com
12. IPD Sharing Statement
Learn more about this trial
Stem Cell Therapy for Patients With Vascular Occlusive Diseases Such as Diabetic Foot
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