19F Hot Spot MRI of Human Adipose-derived Stem Cells for Breast Reconstruction (CS-1000)
|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: NCT02035085|
Recruitment Status : Recruiting
First Posted : January 14, 2014
Last Update Posted : August 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: CS-1000 labeled SVF cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||This is a First-in-man, Phase I Study Utilizing 19F Magnetic Resonance Imaging (MRI) to Track Autologous, Adipose Derived Stem Cells.|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||December 2018|
Breast cancer patients with RIF 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.
Drug: CS-1000 labeled SVF cells
Patients will undergo autologous transplantation of CS-1000 labelled SVF cells in a sterile environment.
- 19F MRI signal over time [ Time Frame: within 18 months ]The engraftment of transplanted cells will be tracked in ways not possible before, using the total fluorine signal as surrogate marker for cell persistence and survival.
- Maintenance of breast contour and volume [ Time Frame: within 18 months ]CTCAE/CTEP scale examination criteria (retraction, atrophy, breast and arm edema, ulceration, telangiectasia, and induration/fibrosis will be used for assessments.
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): NCT02035085
|Contact: Jeff Bulte, PhDemail@example.com|
|Contact: Lorena Gapasin, BSN, RNfirstname.lastname@example.org|
|United States, Maryland|
|Lutherville-Timonium, Maryland, United States, 21093|
|Contact: Ricardo Rodriguez, MD 410-494-8100 email@example.com|
|Principal Investigator:||Jeff WM Bulte, PhD||Johns Hopkins University|
|Study Director:||Ricardo Rodriguez, MD||Cosmeticsurg.net|