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

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ClinicalTrials.gov Identifier: NCT02796079
Recruitment Status : Unknown
Verified April 2017 by Jie Shen, The Third Affiliated Hospital of Southern Medical University.
Recruitment status was:  Recruiting
First Posted : June 10, 2016
Last Update Posted : April 6, 2017
Sponsor:
Collaborators:
Nanfang Hospital of Southern Medical University
Academy Military Medical Science, China
The Fifth Affiliated Hospital of Southern Medical University
Southern Medical University, China
Information provided by (Responsible Party):
Jie Shen, The Third Affiliated Hospital of Southern Medical University

Tracking Information
First Submitted Date  ICMJE May 30, 2016
First Posted Date  ICMJE June 10, 2016
Last Update Posted Date April 6, 2017
Study Start Date  ICMJE January 2015
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2016)
Area of diabetic foot ulcers [ Time Frame: 3 months ]
To determine the ability of MSC to facilitate and accelerate diabetic foot ulcers healing.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02796079 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2016)
  • Improvement of transcutaneous oxygen partial pressure (TcPO2) [ Time Frame: 3 months ]
    Improvement of local perfusion.
  • Improvement of microvascular cutaneous reactivity by laser Doppler perfusion monitoring (LDPM) [ Time Frame: 3 months ]
  • Pain (Visual-Analog Scale) [ Time Frame: 3 months ]
    Measure of the subjective symptom of pain.
  • Walking distance (treadmill) if possible [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Study Using Autologous Bone Marrow Stem Cell for Diabetes Related Vascular Complications
Official Title  ICMJE A Clinical Study Using Autologous Bone Marrow Stem Cell for Diabetes Related Vascular Complications
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Peripheral Vascular Disease
  • Ischemia
  • Diabetic Foot
Intervention  ICMJE
  • Biological: mesenchymal stem cells
    stem cell acquisition, processing and reinfection, to evaluate the efficacy by using autologous bone marrow stem cell
  • Biological: saline
    saline injections
Study Arms  ICMJE
  • Experimental: Autologous Bone Marrow Stem Cell
    Mesenchymal stem cells derived from bone marrow infusion
    Intervention: Biological: mesenchymal stem cells
  • Placebo Comparator: saline
    saline injections
    Intervention: Biological: saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 6, 2016)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02796079
Other Study ID Numbers  ICMJE ThirdSouthernMedical
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jie Shen, The Third Affiliated Hospital of Southern Medical University
Study Sponsor  ICMJE Jie Shen
Collaborators  ICMJE
  • Nanfang Hospital of Southern Medical University
  • Academy Military Medical Science, China
  • The Fifth Affiliated Hospital of Southern Medical University
  • Southern Medical University, China
Investigators  ICMJE
Principal Investigator: Jie Shen The Third Affiliated Hospital of Southern Medical University
PRS Account The Third Affiliated Hospital of Southern Medical University
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP