A Phase 1 interventional study of Adipose-derived stem cell and saline in Peripheral Vascular Disease, Ischemia and Diabetic Foot, sponsored by Jie Shen. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-04-07.
Sponsored by Jie Shen · Phase 1, Interventional, and Treatment
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.
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.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 240 is above the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Jie Shen is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Mesenchymal stem cells derived from adipocyte transplantation
Biological: Adipose-derived stem cell
saline injections
Biological: saline
stem cell acquisition, processing and reinfection, to evaluate the efficacy of adipose-derived stem cell.
Area of diabetic foot ulcers
To determine the ability of MSC to facilitate and accelerate diabetic foot ulcers healing.
Time frame: 3 months
Improvement of transcutaneous oxygen partial pressure (TcPO2)
Improvement of local perfusion.
Time frame: 3 months
Improvement of microvascular cutaneous reactivity by laser Doppler perfusion monitoring (LDPM)
Time frame: 3 months
Pain (Visual-Analog Scale)
Measure of the subjective symptom of pain.
Time frame: 3 months
Walking distance (treadmill) if possible
Time frame: 3 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Jie Shen