Treatment of Breast Cancer-related Lymphedema With Stem Cells and Fat Grafting

Lymphedema Clinical Trial

Official title:

Treatment of Breast Cancer-related Lymphedema With Stem Cells and Fat Grafting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03776721
• Other study ID #: S-20180117
• Status: Completed
• Phase: Phase 2
• Start date: December 18, 2018
• Est. completion date: June 1, 2021

Study information

• Verified date: June 2021
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Breast cancer-related lymphedema is one of the most common and feared consequences of breast cancer treatment. Currently, lymphedema is primarily addressed conservatively with compression garments. Regenerative medicine may provide a new treatment option for lymphedema. This Phase 3 trial will examine the efficacy, effectiveness and safety of freshly isolated adipose-derived stromal cells administered in conjunction with a fat grafting procedure to the affected axillary region.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Unilateral arm lymphedema secondary to breast cancer treatment including lymph node dissection.

• Cancer free for at least 1 year

• 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 (no lymphedema).

• ASA score of 1 or 2.

• The patient is able to read, understand, and complete Danish questionnaires.

• Pitting lymphedema ISL grade 1 or 2.

• A minimum circumference difference of 2cm or a minimum volume difference of 200mL.

Exclusion Criteria:

• Pregnant or lactating.

• Bilateral lymphedema

• Current or previous malignancies other than breast cancer.

• Insulin-dependent diabetes.

• Diagnosed with any form of psychotic disorder, which may impact study participation.

• Not ceased smoking during treatment.

• Active implantables (e.g. pacemaker or neurostimulator)

• Unrealistic treatment expectations.

• Known hepatitis, HIV or syphilis infection.

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Lymphedema

Intervention

Procedure:
• Liposuction
Liposuction is performed on the abdomen or thighs.
• Fat graft
30mL harvested lipoaspirate is injected at the affected axillary site.
• Sham graf (Saline injection)
30mL saline is injected at the affected axillary site.

Biological:
• Stem cell injection
4mL stem cell suspension injected at the affected axillary site.

Procedure:
• Saline injection
4mL saline injected at the affected axillary site.

Locations

Country	Name	City	State
Denmark	Department of Plastic and Reconstructive Surgery	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in arm volume	Assessed using clinical circumference measurement	Baseline, 3, 6, 9 and 12 months
Secondary	Safety of treatments: Assessed by asking the patient at each visit	Any side effects to treatments. Assessed by asking the patient at each visit.	Baseline, 3, 6, 9 and 12 months
Secondary	Subjective changes assessed using the LYMPH-ICF (Lymphoedema Functioning, Disability and Health) questionaire	Subjective change of lymphedema assessed by questionnaire. Range: 0-100. 100 being the most bothered.	Baseline, 3, 6, 9 and 12 months
Secondary	Subjective changes assessed using DASH (DISABILITIES OF THE ARM, SHOULDER AND HAND) questionaire	Subjective change of lymphedema assessed by questionnaire. Range: 1-5. 5 being the most bothered	Baseline, 3, 6, 9 and 12 months
Secondary	Subjective changes assessed using SF-36 questionnaire	Subjective change of quality of life assessed by questionnaire. Range: 0-100. 0 being the most bothered.	Baseline, 3, 6, 9 and 12 months
Secondary	Change in lymph drainage	Change in lymph drainage assessed by indocyanine-green lymphangiography	Baseline and 12 months
Secondary	Change in conservative lymphedema treatment	Change in use or type of conservative lymphedema treatments	Baseline, 3, 6, 9 and 12 months
Secondary	Change in adverse lymphedema-related events	Change in infection rates and sick-days due to lymphedema.	Baseline, 3, 6, 9 and 12 months
Secondary	Change in L-DEX score (bioimpedance)	Change in L-DEX score of lymphedema arm derived from bioimpedance. Higher values mean more fluid in the lymphedema arm compared to the healthy arm.	Baseline, 3, 6, 9 and 12 months
Secondary	Change in weight and arm tissue composition	Assessed using dual energy x-ray absorptiometry (DXA) scan. Change in values from baseline.	Baseline, 3, 6, 9 and 12 months