An interventional study of Adipose SVF cell and Normal saline in Breast Neoplasms and Skin Abnormalities, sponsored by Seoul National University Hospital. Withdrawn at 1 site in Korea, Republic of. Open to female participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-10-23.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Supportive care
The aim of this study is to evaluate the skin quality of using adipose-drived stromal vascular fraction (SVF) cell taken by automatic centrifuge for adipose-drived cell isolation system into irradiated breasts.
10 participants who taken conservative mastectomy will be enrolled
Process
Duration of study
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
Browse Breast Neoplasms studies →Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
adipose SVF cell transfer to the half of irradiated breast
Biological: Adipose SVF cell
Normal saline inject to the half of irradiated breast
Biological: Normal saline
adipose SVF cell transfer to the half of irradiated breast
Normal saline inject to the half of irradiated breast
The change in the breast skin thickness of the pre and post SVF graft from baseline at 12week after procedure
The efficacy is assessed by breast skin thickness measured by radiologist using breast ultrasonography
Time frame: change in the breast skin thickness from baseline at 12 week
Plan to share: Undecided
No publications or documents are linked to this record.
This study is withdrawn, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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