A Clinical Study Using Autologous Bone Marrow Stem Cell for Diabetes Related Vascular Complications
NCT ID: NCT02796079
Last Updated: 2017-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
240 participants
INTERVENTIONAL
2015-01-31
2018-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Autologous Bone Marrow Stem Cell
Mesenchymal stem cells derived from bone marrow infusion
mesenchymal stem cells
stem cell acquisition, processing and reinfection, to evaluate the efficacy by using autologous bone marrow stem cell
saline
saline injections
saline
saline injections
Interventions
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mesenchymal stem cells
stem cell acquisition, processing and reinfection, to evaluate the efficacy by using autologous bone marrow stem cell
saline
saline injections
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Nanfang Hospital, Southern Medical University
OTHER
Academy Military Medical Science, China
INDUSTRY
The Fifth Affiliated Hospital of Southern Medical University
OTHER
Southern Medical University, China
OTHER
Jie Shen
OTHER_GOV
Responsible Party
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Jie Shen
doctor
Principal Investigators
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Jie Shen
Role: PRINCIPAL_INVESTIGATOR
The Third Affiliated Hospital of Southern Medical University
Locations
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the Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ThirdSouthernMedical
Identifier Type: -
Identifier Source: org_study_id
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