Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-02-23 @ 8:56 PM
Study NCT ID:
NCT00616135
Status:
COMPLETED
Last Update Posted:
2011-05-17
First Post:
2008-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Autologous Fat Enhanced w/ Regenerative Cells Transplanted to Reconstruct Breast Deformities After Lumpectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D018270', 'term': 'Carcinoma, Ductal, Breast'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002277', 'term': 'Carcinoma'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D044584', 'term': 'Carcinoma, Ductal'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-13', 'studyFirstSubmitDate': '2008-02-05', 'studyFirstSubmitQcDate': '2008-02-05', 'lastUpdatePostDateStruct': {'date': '2011-05-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient and physician satisfaction with functional and cosmetic results. Improvement in overall breast deformity measured at 12 months compared to baseline.', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Change in breast volume and shape at 6 and 12 Months compared to baseline. Improvement in skin pigmentation abnormalities at 6 and 12 months compared to Baseline. Improvement in overall breast deformity at 6 Months compared to Baseline.', 'timeFrame': '6 months and 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['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'], 'conditions': ['Breast Neoplasms', 'Carcinoma, Ductal, Breast', 'Mammaplasty', 'Mastectomy, Segmental, Lumpectomy, Breast Reconstruction,']}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females with a history of T2N0M0 breast carcinoma (tumor ≤3 cm in largest dimension)\n* Surgical or endoscopic segmental mastectomy or quadrantectomy (lumpectomy)\n* Clean surgical margins\n* No prosthesis in breast(s) to undergo treatment\n* Ability to undergo lipoaspiration\n* Last treatment for breast cancer ≥ 12 months prior to enrollment with absence of recurrence (patients on anti-estrogen adjuvant therapy are NOT excluded)\n* No evidence of recurrence of cancer based on mammogram or breast exam prior to enrollment\n* Objective signs of mild breast damage post Breast Conservation Therapy\n* Type I Cosmetic Sequelae Classification\n* A minimum of 1 cm of soft tissue (e.g. breast or fat) is available between the skin and chest wall at the recipient site\n* A minimum of two-thirds of the breast is remaining post Breast Conservation Therapy\n* No continuous adhesion of skin to bone \\>3 cm in diameter\n* The volume and shape of the defect(s) must be conducive to correction during a single treatment session (maximum defect volume ≤150 mL in breast(s) to undergo treatment)\n\nExclusion Criteria:\n\n* History of autoimmune disorder (e.g., Systemic Lupus Erythematosus \\[SLE\\])\n* History of connective, metabolic or atrophic skin disease\n* History of keloid scarring\n* Chronic use (\\>7 consecutive days) of anticoagulants (such as aspirin) or NSAIDs within 15 days prior to enrollment\n* Life expectancy ≤ 2 years\n* Recurrence or active malignancy requiring radiation or surgical treatment ≤12 months prior to enrollment\n* Presence of any other known malignancy\n* Body Mass Index (BMI) \\>30\n* Plan to undergo weight reduction surgery or foresee any significant weight changes during the study (defined as changes in BMI \\>5 compared to baseline\n* Presence of contraindications to MRI'}, 'identificationModule': {'nctId': 'NCT00616135', 'acronym': 'RESTORE-2', 'briefTitle': 'Study of Autologous Fat Enhanced w/ Regenerative Cells Transplanted to Reconstruct Breast Deformities After Lumpectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cytori Therapeutics'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'RESTORE-2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ADRC-Enhanced Autologous Fat Transplant', 'type': 'PROCEDURE', 'description': 'Autologous fat harvested from the patient is enhanced with ADRCs derived from a portion of the harvested fat and transplanted into the breast(s) that have a volume deficit post lumpectomy. This is a single arm study with no control. All patients receive cell therapy.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brussels', 'country': 'Belgium', 'facility': 'Jules Bordet Institute of Cancer', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '50134', 'city': 'Florence', 'country': 'Italy', 'facility': 'Università degli Studi di Firenze', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '28007', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital General Universitario Gregorio Marañon', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '46009', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Instituto Valenciano Oncologia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': 'G4 0SF', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Glasgow Royal Infirmary', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cytori Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Sean Gemmill, MS, RAC; Clinical Research Manager', 'oldOrganization': 'Cytori Therapeutics'}}}}