Umbilical Cord Mesenchymal Stem Cells Infusion for Diabetes Related Vascular Complications
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02834858|
Recruitment Status : Recruiting
First Posted : July 15, 2016
Last Update Posted : April 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Vascular Disease Ischemia Diabetic Foot||Biological: Umbilical Cord Mesenchymal Stem Cells Biological: saline||Phase 1|
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 the investigators 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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Umbilical Cord Mesenchymal Stem Cells Infusion for Diabetes Related Vascular Complications|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
Experimental: Umbilical Cord Mesenchymal Stem Cells
Umbilical Cord Mesenchymal Stem Cells Infusion.
Biological: Umbilical Cord Mesenchymal Stem Cells
stem cell acquisition, processing and reinfection, to evaluate the efficacy by using umbilical cord mesenchymal stem cells
Placebo Comparator: saline
- Area of diabetic foot ulcers [ Time Frame: 3 months ]To determine the ability of MSC to facilitate and accelerate diabetic foot ulcers healing.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02834858
|Contact: Jie Shen||+86 firstname.lastname@example.org|
|the Third Affiliated Hospital of Southern Medical University||Recruiting|
|Guangzhou, Guangdong, China, 510515|
|Contact: zhang qun 020-62784060 Zq1979@smu.edu.cn|
|Sub-Investigator: Jie Shen|
|Principal Investigator:||Jie Shen||The Third Affiliated Hospital of Southern Medical University|