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NCT number NCT02035085
Study type Interventional
Source Johns Hopkins University
Contact Jeff Bulte, PhD
Phone 443-287-0996
Email jwmbulte@mri.jhu.edu
Status Recruiting
Phase Phase 1
Start date September 2016
Completion date December 2017

Clinical Trial Summary

Six female patients (>18 years of age, pre-menopausal) who have had loco-regional (lumpectomy and radiation) therapy for breast carcinoma and have been at least one-year disease free will undergo liposuction, the autologous SVF cell fraction will be isolated and labeled with CS-1000 in the operating room without entering cell culture, which will then be returned to the patient at the site of breast grafting. Patients will receive a pre-screening MRI . Patients will have an MRI scans over a period of 1 month at Johns Hopkins. Follow-up MRIs at 6,12, and 18 months will also be performed. Only at Johns Hopkins with fluorine being done as part of this investigational study. By performing fluorine MRI and quantification of 19F signal, we hypothesize that the engraftment of transplanted cells can be tracked in ways not possible before, using the total fluorine signal as surrogate marker for cell persistence and survival. We expect that a clinically successful outcome (maintenance of breast contour and volume) will be positively correlated with cell survival. The outcome of this study may pave the way for using 19F MRI cell tracking as a new tool for stem cell therapy in a variety of clinical applications.


Clinical Trial Description

n/a


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


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