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Sponsored by: |
Cytori Therapeutics |
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Information provided by: | Cytori Therapeutics |
ClinicalTrials.gov Identifier: | NCT00616135 |
A post-marketing study evaluating the transplantation of autologous fat augmented with Adipose Derived Regenerative Cells (ADRCs), in patients with functional and cosmetic breast deformities post segmental mastectomy or quadrantectomy (lumpectomy).
Condition | Intervention | Phase |
---|---|---|
Breast Neoplasms Carcinoma, Ductal, Breast Mammoplasty Mastectomy, Segmental, Lumpectomy, Breast Reconstruction, |
Procedure: ADRC-Enhanced Autologous Fat Transplant |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Clinical Evaluation Of Adipose Derived Regenerative Cells In The Treatment Of Patients With BrEast Deformities Post Segmental Breast ResecTion (Lumpectomy) With Or Without Radiation ThErapy. A Phase IV Post Market Study. |
Estimated Enrollment: | 70 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Amanda Lehr | 858-875-5219 | alehr@cytoritx.com |
Contact: Michael Martin | 858-875-5212 | mmartin@cytoritx.com |
Belgium | |
Jules Bordet Institute of Cancer | Recruiting |
Brussels, Belgium | |
Principal Investigator: Rika Deraemaecker, MD | |
Italy | |
Università degli Studi di Firenze | Recruiting |
Florence, Italy, 50134 | |
Contact: Dr. Claudio Calabrese, M.D. +39 335 6553311 c.cal@iol.it | |
Principal Investigator: Claudio Calabrese, MD | |
Sub-Investigator: Lorenzo Orzalesi, MD | |
Sub-Investigator: Catherina Urena, MD | |
Spain | |
Hospital General Universitario Gregorio Marañon | Recruiting |
Madrid, Spain, 28007 | |
Contact: Dra Rosa Perez Cano, M.D. + 34 915868387 rosaperezcano@hotmail.com | |
Principal Investigator: Rosa Perez Cano, MD | |
Sub-Investigator: Jose M Lasso Vasquez, MD | |
Instituto Valenciano Oncologia | Recruiting |
Valencia, Spain, 46009 | |
Contact: Belén Merck, M.D. +34961114018 belenmerck@yahoo.es | |
Principal Investigator: Carlos Vazquez Albaladejo, M.D. | |
United Kingdom, Scotland | |
Glasgow Royal Infirmary | Recruiting |
Glasgow, Scotland, United Kingdom, G4 0SF | |
Contact: Lesley Kelly +44 773 956 5002 Lesleykelly2@gcc.scot.nhs.uk | |
Principal Investigator: Eva Weiler-Mithoff, MD | |
Sub-Investigator: Vivek Sivarajan, MD | |
Sub-Investigator: Clare Jo Tollan, MD |
Study Director: | Alexander M Milstein, MD | Cytori Therapeutics |
Responsible Party: | Cytori Therapeutics ( Alexander M. Milstein, MD; Vice President of Clinical Development ) |
Study ID Numbers: | RESTORE-2 |
Study First Received: | February 5, 2008 |
Last Updated: | March 31, 2009 |
ClinicalTrials.gov Identifier: | NCT00616135 History of Changes |
Health Authority: | United Kingdom: Research Ethics Committee |
Breast Stem Cell Adipose Derived Stem Cells Adipose Derived Regenerative Cells ADRC Reconstructive Breast Surgery Breast Reconstruction Cancer Carcinoma |
Autologous fat transplantation Autologous fat Cosmetic breast deformities Functional breast deformity Lumpectomy Segmental mastectomy Quadrantectomy breast conservation therapy |
Carcinoma, Ductal Skin Diseases Breast Neoplasms Carcinoma, Ductal, Breast Adenocarcinoma |
Congenital Abnormalities Breast Diseases Neoplasms, Glandular and Epithelial Carcinoma |
Carcinoma, Ductal Neoplasms Neoplasms by Histologic Type Neoplasms by Site Skin Diseases Breast Neoplasms |
Carcinoma, Ductal, Breast Neoplasms, Ductal, Lobular, and Medullary Adenocarcinoma Breast Diseases Neoplasms, Glandular and Epithelial Carcinoma |