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Umbilical Cord Mesenchymal Stem Cells Injection for Diabetic Foot

Primary Purpose

Diabetic Foot, Critical Limb Ischemia, Mesenchymal Stem Cells

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
umbilical cord mesenchymal stem cells
Standard Therapy
Sponsored by
Qingdao University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot focused on measuring Diabetic foot, critical limb ischemia, mesenchymal stem cells, umbilical cord

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diabetes mellitus Type 2
  • Age 18 - 75 years
  • Subject has an Ankle-brachial index < 0.9
  • Subject has had previous conservative treatment which resulted in little or no improvement
  • Subject has had no stem cell treatment within the past 6 months
  • No sufficient response to best standard care delivered for six weeks.
  • No surgical or radiological interventional option for revascularisation as confirmed by a vascular surgeon and an interventional radiologist
  • Signed informed consent
  • Absence of life-threatening complications from the ischemic limb
  • Life expectancy more than 2 years
  • Negative pregnancy test when applicable

Exclusion Criteria:

  • Diabetic retinopathy
  • History of neoplasm or hematological disease
  • Uncontrolled high blood pressure (>180/110)
  • Severe cardiac insufficiency (New York Heart Association [NYHA] IV) or ejection fraction<30%
  • Malignant ventricular arrythmia
  • Deep venous thrombosis during the last 3 months
  • Active bacterial infection
  • Body mass index > 35 Kg/m2
  • Stroke or myocardial infarction during the last 3 months

Sites / Locations

  • Stem Cell Research Center of Medical School Hospital of Qingdao University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

umbilical cord mesenchymal stem cells

Standard Therapy

Arm Description

Multiple intra muscular injection of mesenchymal stem cells derived from human umbilical cord.

Any therapy for diabetic foot which is routinely practiced and accepted in China

Outcomes

Primary Outcome Measures

Angiographic evaluation of angiogenesis at ischemic limb

Secondary Outcome Measures

Pain
Ankle-Brachial pressure index
Wound healing (wound size, wound stage)
Walking distance
Rate and extent of amputations

Full Information

First Posted
October 6, 2010
Last Updated
October 12, 2010
Sponsor
Qingdao University
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1. Study Identification

Unique Protocol Identification Number
NCT01216865
Brief Title
Umbilical Cord Mesenchymal Stem Cells Injection for Diabetic Foot
Official Title
Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Injection for Diabetic Foot
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
July 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Qingdao University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for diabetic foot is safe and effective in the management of diabetic foot ischemia, the therapeutic effect of stem cells is caused by improving blood circulation in ischemic limb which would in turn promote ulcer healing, prevent amputation of limb and relieve the Sevier pain of ischemia.
Detailed Description
Type 2 diabetic patients with diabetic foot were enrolled and randomized to either transplanted group or control group. Patients in transplanted group received the stem cells treatment,Patients in control group received the standard treatment. After culture in vitro, umbilical cord mesenchymal stem cells should go through safety evaluation which include culture and check of pathogenic microorganisms (bacteria, mycoplasma, chlamydia, eumycete and viruses) of the cells medium and karyotype analysis of the mesenchymal stem cells. Only the safe cells were harvested and transplanted by multiple intramuscular injections into the impaired lower limbs. Follow-up index include: efficacy (pain,ulcer healing rate, lower limb amputation rate and ,ankle-brachial index,magnetic resonance angiography,electromyogram) and safety (infection of the injection site, fever, and tumour generation).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot, Critical Limb Ischemia, Mesenchymal Stem Cells, Umbilical Cord
Keywords
Diabetic foot, critical limb ischemia, mesenchymal stem cells, umbilical cord

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
umbilical cord mesenchymal stem cells
Arm Type
Experimental
Arm Description
Multiple intra muscular injection of mesenchymal stem cells derived from human umbilical cord.
Arm Title
Standard Therapy
Arm Type
Active Comparator
Arm Description
Any therapy for diabetic foot which is routinely practiced and accepted in China
Intervention Type
Biological
Intervention Name(s)
umbilical cord mesenchymal stem cells
Other Intervention Name(s)
mesenchymal stem cells
Intervention Description
5*10/7 per ischemic limb
Intervention Type
Drug
Intervention Name(s)
Standard Therapy
Other Intervention Name(s)
Drug therapy
Intervention Description
Any thing directed to improve blood perfusion in the limb example.Heparin,Antiplatelet agents etc
Primary Outcome Measure Information:
Title
Angiographic evaluation of angiogenesis at ischemic limb
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Pain
Time Frame
3 months
Title
Ankle-Brachial pressure index
Time Frame
3 months
Title
Wound healing (wound size, wound stage)
Time Frame
3 months
Title
Walking distance
Time Frame
3 months
Title
Rate and extent of amputations
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diabetes mellitus Type 2 Age 18 - 75 years Subject has an Ankle-brachial index < 0.9 Subject has had previous conservative treatment which resulted in little or no improvement Subject has had no stem cell treatment within the past 6 months No sufficient response to best standard care delivered for six weeks. No surgical or radiological interventional option for revascularisation as confirmed by a vascular surgeon and an interventional radiologist Signed informed consent Absence of life-threatening complications from the ischemic limb Life expectancy more than 2 years Negative pregnancy test when applicable Exclusion Criteria: Diabetic retinopathy History of neoplasm or hematological disease Uncontrolled high blood pressure (>180/110) Severe cardiac insufficiency (New York Heart Association [NYHA] IV) or ejection fraction<30% Malignant ventricular arrythmia Deep venous thrombosis during the last 3 months Active bacterial infection Body mass index > 35 Kg/m2 Stroke or myocardial infarction during the last 3 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianxia Hu, MD
Phone
86-0532-82911676
Email
qdyxyhjx@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hong Gao, MS
Phone
86-0532-82911676
Email
honggaogloria@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yangang Wang, MD Phd
Organizational Affiliation
The Affiliated Hospital of Qingdao University
Official's Role
Study Director
Facility Information:
Facility Name
Stem Cell Research Center of Medical School Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266003
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianxia Hu, MD
Phone
86-0532-82911676
Email
qdyxyhjx@126.com
First Name & Middle Initial & Last Name & Degree
Hong Gao, MS
Phone
86-0532-82911676
Email
honggaogloria@gmail.com
First Name & Middle Initial & Last Name & Degree
Yangang Wang, MD PhD

12. IPD Sharing Statement

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Umbilical Cord Mesenchymal Stem Cells Injection for Diabetic Foot

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