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

NCT02035085 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: NA_00086592
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

19F MRI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Maintenance of breast contour and volume

  within 18 months

Study Arms (1)

CS-1000

EXPERIMENTAL

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

Interventions

CS-1000 labeled SVF cells DRUG

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

CS-1000

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Evidence of metastatic disease
• Less than 18 months disease-free interval
• Unable to undergo MRI:
• a) 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Cosmeticsurg.net: collaborator

Study Sites (1)

CosmeticSurg

Lutherville-Timonium, Maryland, 21093, United States

Location

Related Publications (1)

• 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.

  PMID: 26511652 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jeff WM Bulte, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Ricardo Rodriguez, MD

  Cosmeticsurg.net

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: January 14, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: June 27, 2022

Record last verified: 2022-06

Locations

US (1)