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

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.

Study Overview

• Status: Withdrawn
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: CS-1000 labeled SVF cells

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Lutherville-Timonium, Maryland, United States, 21093
      • CosmeticSurg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
19F MRI signal over time	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.	within 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maintenance of breast contour and volume	CTCAE/CTEP scale examination criteria (retraction, atrophy, breast and arm edema, ulceration, telangiectasia, and induration/fibrosis will be used for assessments.	within 18 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Cosmeticsurg.net
• Investigators: Principal Investigator: Jeff WM Bulte, PhD, Johns Hopkins University; Study Director: Ricardo Rodriguez, MD, Cosmeticsurg.net

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: December 19, 2013
• First Submitted That Met QC Criteria: January 10, 2014
• First Posted (Estimate): January 14, 2014

Study Record Updates

• Last Update Posted (Actual): June 27, 2022
• Last Update Submitted That Met QC Criteria: June 21, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: 19F MRI
• Other Study ID Numbers: NA_00086592

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No