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A Clinical Study Using Adipose-derived Stem Cells for Diabetic Foot

Primary Purpose

Peripheral Vascular Disease, Ischemia, Diabetic Foot

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Adipose-derived stem cell

saline

About this trial

This is an interventional treatment trial for Peripheral Vascular Disease focused on measuring Adipose-derived Stem Cells

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diabetes mellitus Type 2 or Type 1
Age between 18-80 years
Chronic foot ulcer more than 6 weeks
No sufficient response to best standard care delivered for six weeks.
PAD up to Fontaine stage III or IV period
CLI with the ankle brachial index (index ankle-brachial, ABI) <0.7 and (or) the -percutaneous oxygen partial pressure (oxygen tension transcutaneous, TcPO2) <30mmHg

Exclusion Criteria:

HbA1c >12%
Hemoglobin <10 mg/dl
Creatinine clearance rate <30ml/min
Systemic bacterial, viral infections (Mei Du, hepatitis, cytomegalovirus infection, - HIV, B19 infection, herpes virus infection) and sepsis
Have accepted the treatment of stem cells or growth factors
Have a history of malignant disease
Pregnancy
Mental illness history
Abnormal coagulation function
Allergic reaction
Severe cardiac insufficiency (III-IV NYHA)
Using vasoactive substances

Sites / Locations

the Third Affiliated Hospital of Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Adipose-derived stem cell

saline

Arm Description

Mesenchymal stem cells derived from adipocyte transplantation

saline injections

Outcomes

Primary Outcome Measures

Area of diabetic foot ulcers

To determine the ability of MSC to facilitate and accelerate diabetic foot ulcers healing.

Secondary Outcome Measures

Improvement of transcutaneous oxygen partial pressure (TcPO2)

Improvement of local perfusion.

Improvement of microvascular cutaneous reactivity by laser Doppler perfusion monitoring (LDPM)

Pain (Visual-Analog Scale)

Measure of the subjective symptom of pain.

Walking distance (treadmill) if possible

Full Information

NCT ID

NCT02831075

First Posted

July 9, 2016

Last Updated

April 5, 2017

Sponsor

Jie Shen

Collaborators

Nanfang Hospital, Southern Medical University, Academy Military Medical Science, China, The Fifth Affiliated Hospital of Southern Medical University, Southern Medical University, China

1. Study Identification

Unique Protocol Identification Number

NCT02831075

Brief Title

A Clinical Study Using Adipose-derived Stem Cells for Diabetic Foot

Official Title

A Clinical Study Using Adipose-derived Stem Cells for Diabetic Foot

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Unknown status

Study Start Date

January 2015 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jie Shen

Collaborators

Nanfang Hospital, Southern Medical University, Academy Military Medical Science, China, The Fifth Affiliated Hospital of Southern Medical University, Southern Medical University, China

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Stem cell therapy has been a new and effective therapy in recent years for diabetic foot.This study intends to establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.

Detailed Description

Diabetic foot is one of the most serious chronic complications of diabetic patients, and still lacking effective treatments. Stem cell therapy has been a new and effective therapy in recent years for diabetic foot. Combined with the previous studies of our research group, this study intends to transform part of the results of this research, establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Vascular Disease, Ischemia, Diabetic Foot

Keywords

Adipose-derived Stem Cells

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Adipose-derived stem cell

Arm Type

Experimental

Arm Description

Mesenchymal stem cells derived from adipocyte transplantation

Arm Title

saline

Arm Type

Placebo Comparator

Arm Description

saline injections

Intervention Type

Biological

Intervention Name(s)

Adipose-derived stem cell

Intervention Description

stem cell acquisition, processing and reinfection, to evaluate the efficacy of adipose-derived stem cell.

Intervention Type

Biological

Intervention Name(s)

saline

Primary Outcome Measure Information:

Title

Area of diabetic foot ulcers

Description

To determine the ability of MSC to facilitate and accelerate diabetic foot ulcers healing.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Improvement of transcutaneous oxygen partial pressure (TcPO2)

Description

Improvement of local perfusion.

Time Frame

3 months

Title

Improvement of microvascular cutaneous reactivity by laser Doppler perfusion monitoring (LDPM)

Time Frame

3 months

Title

Pain (Visual-Analog Scale)

Description

Measure of the subjective symptom of pain.

Time Frame

3 months

Title

Walking distance (treadmill) if possible

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diabetes mellitus Type 2 or Type 1 Age between 18-80 years Chronic foot ulcer more than 6 weeks No sufficient response to best standard care delivered for six weeks. PAD up to Fontaine stage III or IV period CLI with the ankle brachial index (index ankle-brachial, ABI) <0.7 and (or) the -percutaneous oxygen partial pressure (oxygen tension transcutaneous, TcPO2) <30mmHg Exclusion Criteria: HbA1c >12% Hemoglobin <10 mg/dl Creatinine clearance rate <30ml/min Systemic bacterial, viral infections (Mei Du, hepatitis, cytomegalovirus infection, - HIV, B19 infection, herpes virus infection) and sepsis Have accepted the treatment of stem cells or growth factors Have a history of malignant disease Pregnancy Mental illness history Abnormal coagulation function Allergic reaction Severe cardiac insufficiency (III-IV NYHA) Using vasoactive substances

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jie Shen

Phone

+86 13808893818

shenjiedr@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jie Shen

Organizational Affiliation

The Third Affiliated Hospital of Southern Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

the Third Affiliated Hospital of Southern Medical University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510515

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhang Qun

Phone

020-62784060

Zq1979@smu.edu.cn

First Name & Middle Initial & Last Name & Degree

Jie Shen

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

A Clinical Study Using Adipose-derived Stem Cells for Diabetic Foot

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