19F Hot Spot MRI of Human Adipose-derived Stem Cells for Breast Reconstruction

Breast Cancer Clinical Trial

— CS-1000  

Official title:

This is a First-in-man, Phase I Study Utilizing 19F Magnetic Resonance Imaging (MRI) to Track Autologous, Adipose Derived Stem Cells.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02035085
• Other study ID #: NA_00086592
• Status: Withdrawn
• Phase: Phase 1
• Start date: June 2014
• Est. completion date: June 2022

Study information

• Verified date: June 2022
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• CS-1000 labeled SVF cells
Patients will undergo autologous transplantation of CS-1000 labelled SVF cells in a sterile environment.

Locations

Country	Name	City	State
United States	CosmeticSurg	Lutherville-Timonium	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Cosmeticsurg.net

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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