Treatment of Breast Cancer Related Lymphedema With Cell-a... | NCT02592213

Studies
Treatment of Breast Cancer Related Lymphedema With Cell-assisted Lipotransfer

NCT02592213

Sponsor

Odense University Hospital

Status

Unknown status

Last Update Posted

Jun 1, 2020Actual

Enrollment

10Estimated

Phase

Phase 1Phase 2

Conditions

Lymphedema

Interventions

Cell-assisted lipotransfer

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Sep 2020Estimated

Completion Date

Sep 2020Estimated

First Submitted Date

Oct 28, 2015

First Submission Date that Met QC Criteria

Oct 29, 2015

First Posted Date

Oct 30, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2020

Last Update Posted Date

Jun 1, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Breast cancer is the most common cancer type among women. Treatment in many cases involves axillary lymphadenectomy followed by radiation therapy. This increases the risk of lymphedema development which occurs in up to 30% of such cases. The present treatment paradigm is conservative with compression garments. There is a need for more effective treatment options and regenerative medicine offers hope for a change to a more curative approach. This Phase 2 trial will examine the efficacy and safety of treatment with freshly isolated adipose-derived stromal cells administered as a cell-assisted lipotransfer to the affected axillary region.

Detailed Description

Breast cancer is the most common cancer type among women. Treatment in many cases involves axillary lymphadenectomy followed by radiation therapy. This increases the risk of lymphedema development which occurs in up to 30% of such cases. The present treatment paradigm is conservative with compression garments. There is a need for more effective treatment options and regenerative medicine offers hope for a change to a more curative approach. This Phase 2 trial will examine the efficacy and safety of treatment with freshly isolated adipose-deried stromal cells administered as a cell-assisted lipotransfer to the affected axillary region.

Investigators plan to include 10 patients with unilateral lymphedema after previous breast cancer treatment

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Experimental	Treatment of lymphedema with cell-assisted lipotransfer using autologous stromal vascular fraction	Procedure: Cell-assisted lipotransfer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cell-assisted lipotransfer	Procedure	Stromal vascular fraction, autologous. Isolated using Celution System (Cytori)	Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in arm volume	Assessed by clinical measurements	Baseline, 1, 3, 6, 12 and 48 months

Secondary Outcomes

Measure	Description	Time Frame
Side effects of treatment	Any side effects of experimental treatment. Assessed by asking the patient at each visit. All reported findings will be reported at study completion	1, 3, 6, 12 and 48 months
Subjective change assessed LYMQOL questionnaire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Unilateral arm lymphedema secondary to breast cancer treatment including lymph node dissection.
The patient understands the nature and purpose of this study and the study procedures and has signed informed consent.
The opposite upper extremity is healthy.
ASA score of 1 or 2.
The patient is able to read, understand, and complete Danish questionnaires.
Lymphedema grade 1 or 2. A minimum circumference distance of 2cm on either lower or upper arm.

Exclusion Criteria:

The patient is pregnant or lactating.
The patient has bilateral lymphedema of the upper extremities.
The patient has or has had other malignancies other than breast cancer.
The patient is treated with anti-diabetic medication.
The patient is diagnosed with any form of psychotic disorder.
The patient is smoking.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Navid M Toyserkani, MD	Dept. Plastic and Reconstructive Surgery, Odense University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Odense University Hospital		Odense		5000	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28653440	Derived	Toyserkani NM, Jensen CH, Andersen DC, Sheikh SP, Sorensen JA. Treatment of Breast Cancer-Related Lymphedema with Adipose-Derived Regenerative Cells and Fat Grafts: A Feasibility and Safety Study. Stem Cells Transl Med. 2017 Aug;6(8):1666-1672. doi: 10.1002/sctm.17-0037. Epub 2017 Jun 27.
27151914	Derived

ID	Term
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases