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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 : December 19, 2020
Sponsor:
Collaborator:
Cosmeticsurg.net
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: CS-1000 labeled SVF cells Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: This is a First-in-man, Phase I Study Utilizing 19F Magnetic Resonance Imaging (MRI) to Track Autologous, Adipose Derived Stem Cells.
Estimated Study Start Date : December 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: CS-1000 labeled SVF cells
Patients will undergo autologous transplantation of CS-1000 labelled SVF cells in a sterile environment.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Jeff Bulte, PhD 443-287-0996 jwmbulte@mri.jhu.edu
Contact: Ricardo Rodriguez, MD 410-494-8100 dr.rodriguez@me.com

Locations
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United States, Maryland
CosmeticSurg Recruiting
Lutherville-Timonium, Maryland, United States, 21093
Contact: Ricardo Rodriguez, MD    410-494-8100    dr.rodriguez@me.com   
Sponsors and Collaborators
Johns Hopkins University
Cosmeticsurg.net
Investigators
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Principal Investigator: Jeff WM Bulte, PhD Johns Hopkins University
Study Director: Ricardo Rodriguez, MD Cosmeticsurg.net
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02035085    
Other Study ID Numbers: NA_00086592
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: December 19, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
19F MRI