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19F Hot Spot MRI of Human Adipose-derived Stem Cells for Breast Reconstruction (CS-1000)

This study is currently recruiting participants.
Verified September 2016 by Johns Hopkins University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02035085
First Posted: January 14, 2014
Last Update Posted: August 21, 2017
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.
Collaborator:
Cosmeticsurg.net
Information provided by (Responsible Party):
Johns Hopkins University
December 19, 2013
January 14, 2014
August 21, 2017
September 2016
June 2018   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02035085 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
19F Hot Spot MRI of Human Adipose-derived Stem Cells for Breast Reconstruction
This is a First-in-man, Phase I Study Utilizing 19F Magnetic Resonance Imaging (MRI) to Track Autologous, Adipose Derived Stem Cells.
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.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
Drug: CS-1000 labeled SVF cells
Patients will undergo autologous transplantation of CS-1000 labelled SVF cells in a sterile environment.
Experimental: CS-1000
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.
Intervention: Drug: CS-1000 labeled SVF cells
Rose LC, Kadayakkara DK, Wang G, Bar-Shir A, Helfer BM, O'Hanlon CF, Kraitchman DL, Rodriguez RL, Bulte JW. Fluorine-19 Labeling of Stromal Vascular Fraction Cells for Clinical Imaging Applications. Stem Cells Transl Med. 2015 Dec;4(12):1472-81. doi: 10.5966/sctm.2015-0113. Epub 2015 Oct 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
6
December 2018
June 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patient capable and willing to sign the Informed Consent (see attached document)
  2. Patient must be willing to complete all visits in this study
  3. Female, >18 years of age
  4. Lumpectomy and radiation therapy for breast carcinoma
  5. 18 month disease free survival
  6. No evidence of metastatic disease
  7. Patient is fit for surgery as determined by preoperative medical clearance workup performed by an independent primary care physician.
  8. Negative pregnancy test.

Exclusion Criteria:

  1. Evidence of metastatic disease
  2. Less than 18 months disease-free interval
  3. Unable to undergo MRI:

3a) Metallic implant 3b) Claustrophobic 4) High risk for surgical intervention because of comorbidities 5) Received treatment with an investigational drug within 30 days of screening.

Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact: Jeff Bulte, PhD 443-287-0996 jwmbulte@mri.jhu.edu
Contact: Lorena Gapasin, BSN, RN 410-955-3267 lgapasi1@jhmi.edu
United States
 
 
NCT02035085
NA_00086592
No
Not Provided
Not Provided
Johns Hopkins University
Johns Hopkins University
Cosmeticsurg.net
Principal Investigator: Jeff WM Bulte, PhD Johns Hopkins University
Study Director: Ricardo Rodriguez, MD Cosmeticsurg.net
Johns Hopkins University
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP