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A Clinical Study Using Autologous Bone Marrow Stem Cell for Diabetes Related Vascular Complications

Primary Purpose

Peripheral Vascular Disease, Ischemia, Diabetic Foot

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
mesenchymal stem cells
saline
Sponsored by
Jie Shen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Vascular Disease

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

Autologous Bone Marrow Stem Cell

saline

Arm Description

Mesenchymal stem cells derived from bone marrow infusion

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

First Posted
May 30, 2016
Last Updated
April 4, 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
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1. Study Identification

Unique Protocol Identification Number
NCT02796079
Brief Title
A Clinical Study Using Autologous Bone Marrow Stem Cell for Diabetes Related Vascular Complications
Official Title
A Clinical Study Using Autologous Bone Marrow Stem Cell for Diabetes Related Vascular Complications
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

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
Autologous Bone Marrow Stem Cell
Arm Type
Experimental
Arm Description
Mesenchymal stem cells derived from bone marrow infusion
Arm Title
saline
Arm Type
Placebo Comparator
Arm Description
saline injections
Intervention Type
Biological
Intervention Name(s)
mesenchymal stem cells
Intervention Description
stem cell acquisition, processing and reinfection, to evaluate the efficacy by using autologous bone marrow stem cell
Intervention Type
Biological
Intervention Name(s)
saline
Intervention Description
saline injections
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
No
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
Email
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
Email
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 Autologous Bone Marrow Stem Cell for Diabetes Related Vascular Complications

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