Clinical Trials Logo

Clinical Trial Summary

Indicated for the Treatment of Secondary Lymphedema Associated with the Treatment of Breast Cancer.

Primary objective is to evaluate the safety and tolerability of a single dose of Lymfactin® in patients with secondary lymphedema associated with the treatment of breast cancer.

Clinical Trial Description

This is an open label, multi-center, uncontrolled first in human trial that uses a standard 3 + 3 dose escalation scheme. Lymfactin® will be administered as a single dose by ex vivo perinodal injection into the fat pad of a flap of tissue containing lymph nodes from the abdominal wall. This flap of tissue will then be surgically implanted into the axillary region of the affected arm. This treatment with Lymfactin® may be performed in conjunction with or without breast reconstruction surgery.

Up to two dose cohorts are planned to be included. Each dose of Lymfactin® will be administered as a single dose via perinodal injection in a volume of 2 mL:

- Cohort 1: Lymfactin® [1 x 10E10 vp]

- Cohort 2: Lymfactin® [1 x 10E11 vp]

Should the dose escalation go up to Cohort 2 with initiation of a subsequent Extension Cohort a total of 15 - 21 patients may be treated in this study. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT02994771
Study type Interventional
Source Herantis Pharma Plc.
Status Active, not recruiting
Phase Phase 1
Start date June 2016
Completion date February 2024

See also
  Status Clinical Trial Phase
Recruiting NCT03572998 - Lymphatic Function in Patients Who Have Undergone Breast Cancer Treatment N/A
Active, not recruiting NCT02895724 - Hyperbaric Oxygen Therapy to Reduce Lymphedema After Breast Cancer -an Explorative Clinical Trial Phase 2
Completed NCT04393168 - Proof-of-concept Study of LymphMonitor 1.0 to Assess the Lymphatic Vessel Function Phase 1
Active, not recruiting NCT03658967 - Clinical Study With Lymfactin® in the Treatment of Patients With Secondary Lymphedema (AdeLE) Phase 2
Recruiting NCT04897035 - A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema N/A
Recruiting NCT03578380 - Supermicrosurgery for Breast Cancer Survivors With Lymphedema. N/A
Recruiting NCT04045860 - Complete Decongestive Therapy on Head and Neck Lymphedema N/A
Recruiting NCT03760744 - Imaging Biomarkers of Lymphatic Dysfunction N/A
Completed NCT03634462 - Complete Decongestive Therapy With Negative Pressure for Lipedema and Lymphedema Therapy N/A
Completed NCT03523494 - Feasibility of Lymph Edema-induced Reticulation Subtraction Based on Computerized Tomography
Completed NCT01748604 - Physical Therapies in the Decongestive Treatment of Lymphedema N/A