Breast NeoplasmsPhase 4RESTORE-2NCT00616135
Study of Autologous Fat Enhanced w/ Regenerative Cells Transplanted to Reconstruct Breast Deformities After Lumpectomy
A Phase 4 study testing ADRC-Enhanced Autologous Fat Transplant in people with Breast Neoplasms and Carcinoma, Ductal, Breast, run by Cytori Therapeutics at 5 sites in 4 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Neoplasms, Carcinoma, Ductal, Breast, Mammaplasty
- What is being tested?
- ADRC-Enhanced Autologous Fat Transplant
- Type of treatment
- Surgery or procedure
- How many people
- 71 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Jun 2008to Nov 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females with a history of T2N0M0 breast carcinoma (tumor ≤3 cm in largest dimension)
- Surgical or endoscopic segmental mastectomy or quadrantectomy (lumpectomy)
- Clean surgical margins
- No prosthesis in breast(s) to undergo treatment
- Ability to undergo lipoaspiration
- Last treatment for breast cancer ≥ 12 months prior to enrollment with absence of recurrence (patients on anti-estrogen adjuvant therapy are NOT excluded)
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- No evidence of recurrence of cancer based on mammogram or breast exam prior to enrollment
- Objective signs of mild breast damage post Breast Conservation Therapy
- Type I Cosmetic Sequelae Classification
- 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
- A minimum of two-thirds of the breast is remaining post Breast Conservation Therapy
- No continuous adhesion of skin to bone >3 cm in diameter
- 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)
Who cannot join
- History of autoimmune disorder (e.g., Systemic Lupus Erythematosus [SLE])
- History of connective, metabolic or atrophic skin disease
- History of keloid scarring
- Chronic use (>7 consecutive days) of anticoagulants (such as aspirin) or NSAIDs within 15 days prior to enrollment
- Life expectancy ≤ 2 years
- Recurrence or active malignancy requiring radiation or surgical treatment ≤12 months prior to enrollment
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- Presence of any other known malignancy
- Body Mass Index (BMI) >30
- Plan to undergo weight reduction surgery or foresee any significant weight changes during the study (defined as changes in BMI >5 compared to baseline
- Presence of contraindications to MRI
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Spain2 sites
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Instituto Valenciano Oncologia
Valencia, 46009
About this 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.
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).
- Conditions
- Breast Neoplasms, Carcinoma, Ductal, Breast, Mammaplasty, Mastectomy, Segmental, Lumpectomy, Breast Reconstruction,
- Being tested
- ADRC-Enhanced Autologous Fat Transplant
- 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
- Medical subject headings
- Breast Neoplasms, Carcinoma, Ductal, Breast, Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADRC-Enhanced Autologous Fat TransplantProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient and physician satisfaction with functional and cosmetic results. Improvement in overall breast deformity measured at 12 months compared to baseline.
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startJun 2008
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cytori Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616135
- Sponsor's protocol ID
- RESTORE-2
- Acronym
- RESTORE-2
- Status last verified
- May 2011
- First submitted
- 5 Feb 2008
- Last updated
- 17 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00616135
- Acronym / sponsor ID
- RESTORE-2 / RESTORE-2
- Conditions
- Breast Neoplasms, Carcinoma, Ductal, Breast, Mammaplasty, Mastectomy, Segmental, Lumpectomy, Breast Reconstruction,
- Keywords
- Breast, Stem Cell, Adipose Derived Stem Cells, Adipose Derived Regenerative Cells, ADRC, Reconstructive Breast Surgery, Breast Reconstruction, Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- Cytori TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 15 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Females with a history of T2N0M0 breast carcinoma (tumor ≤3 cm in largest dimension)
- Surgical or endoscopic segmental mastectomy or quadrantectomy (lumpectomy)
- Clean surgical margins
- No prosthesis in breast(s) to undergo treatment
- Ability to undergo lipoaspiration
Key exclusion criteria (10 listed)
- History of autoimmune disorder (e.g., Systemic Lupus Erythematosus [SLE])
- History of connective, metabolic or atrophic skin disease
- History of keloid scarring
- Chronic use (>7 consecutive days) of anticoagulants (such as aspirin) or NSAIDs within 15 days prior to enrollment
- Life expectancy ≤ 2 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADRC-Enhanced Autologous Fat TransplantAutologous 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. | Procedure or surgery | – |
Primary outcome
Patient and physician satisfaction with functional and cosmetic results. Improvement in overall breast deformity measured at 12 months compared to baseline.
Time frame: 12 months
1 secondary outcome
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.
Time frame: 6 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ADRC-Enhanced Autologous Fat Transplant in people with Breast Neoplasms and Carcinoma, Ductal, Breast, run by Cytori Therapeutics at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain, Belgium, Italy, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient and physician satisfaction with functional and cosmetic results. Improvement in overall breast deformity measured at 12 months compared to baseline. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2011.