NCT02592213

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2015

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2015

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

June 1, 2020

Status Verified

May 1, 2020

Enrollment Period

4.9 years

First QC Date

October 28, 2015

Last Update Submit

May 28, 2020

Conditions

Lymphedema

Outcome Measures

Primary Outcomes (1)

  • Change in arm volume

    Assessed by clinical measurements

    Baseline, 1, 3, 6, 12 and 48 months

Secondary Outcomes (9)

  • Side effects of treatment

    1, 3, 6, 12 and 48 months

  • Subjective change assessed LYMQOL questionnaire

    Baseline, 1, 3, 6, 12 and 48 months

  • Subjective change assessed DASH questionnaire

    Baseline, 1, 3, 6, 12 and 48 months

  • Change in lymph drainage

    Baseline and 12 months

  • Subjective change in feeling of tension in arm assessed by numeric scale from 0-10

    Baseline, 1, 3, 6, 12 and 48 months

  • +4 more secondary outcomes

Study Arms (1)

Treatment

EXPERIMENTAL

Treatment of lymphedema with cell-assisted lipotransfer using autologous stromal vascular fraction

Procedure: Cell-assisted lipotransfer

Interventions

Cell-assisted lipotransferPROCEDURE

Stromal vascular fraction, autologous. Isolated using Celution System (Cytori)

Treatment

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 28653440DERIVED

  • Toyserkani NM, Jensen CH, Sheikh SP, Sorensen JA. Cell-Assisted Lipotransfer Using Autologous Adipose-Derived Stromal Cells for Alleviation of Breast Cancer-Related Lymphedema. Stem Cells Transl Med. 2016 Jul;5(7):857-9. doi: 10.5966/sctm.2015-0357. Epub 2016 May 5.

    PMID: 27151914DERIVED

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Navid M Toyserkani, MD

    Dept. Plastic and Reconstructive Surgery, Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 28, 2015

First Posted

October 30, 2015

Study Start

October 1, 2015

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

June 1, 2020

Record last verified: 2020-05

Locations

DK(1)