Phase2 Clinical Trial of Hepatocyte Growth Factor Gene Therapy for Primary Lymphedema

Phase2 Clinical Trial of Hepatocyte Growth Factor Gene Therapy for Primary Lymphedema - Phase2 Clinical Trial for Primary Lymphedema

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000033159

Enrollment

Registered

2018-07-01

Start date

2018-08-07

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Lymphedema

Interventions

Placebo (Saline 3.0ml x8, im) Low dose (HGF plasmid DNA 0.05mg/3ml x8, im) High dose (HGF plasmid DNA 0.5mg/3ml x8, im)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1, agree to join the study by a document 2, 20<=age<75 3, age of onset <60 4, edema of one limb, the volume is over 20% compared with another side. 5, diagnosed by lymph scintigraphy 6, treated by physical therapy over 3 months 7, agree to prevent pregnancy

Exclusion criteria

Exclusion criteria: 1, stage 3 by ISL classification 2, aplasia or hyperplasia 3, another hereditary 4, malignancy 5, cellulitis at the time of registration 6, received the operation within 90 days 7, severe disease of liver, kidney, heart, or blood 8, alcohol dependence 9, registration of another clinical trials within 90 days 10, the pregnant 11, received the treatment of another gene therapy 12, unfitness patient

Design outcomes

Primary

Measure	Time frame
Quality of Life (SF-36 and LYMQOL) at 12 and 24 week	—

Countries

Japan

Contacts

Public ContactYukihiro Saito

Asahikawa medical university Dep. Surgery, Div. Vascular surgery

lymph_chiken@asahikawa-med.ac.jp0166-68-2880

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026