CompletedPhase 1

Safety Study of Gene Therapy in Treating Critical Leg Ischemia

United States12 participantsStarted 2007-04-03

Plain-language summary

The purpose of this study is to determine the safety, tolerability and preliminary efficacy of intramuscular injections of VM202 for subjects with critical limb ischemia. Subjects selected for this study will have critical limb ischemia that has not responded to standard therapy with symptoms including pain at rest and/or ischemic ulcers.

Who can participate

Age range20 Years – 90 Years

SexALL

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Inclusion criteria

✓. Stable symptoms on standard therapy including anti-platelet agents, vascular rheologic agents, cilostazol, anticoagulant and pain medication for 30 days.
✓. Pain at rest and/or ischemic ulcers for a minimum of 4 weeks.

Exclusion criteria

✕. Hemoglobin less than 9.0 g/dL
✕. White Blood Cell count less than 3,000 cells/mm3
✕. Platelet count less than 75,000 platelets/uL
✕. Fasting glucose greater than 250 mg/dL
✕. AST and/or ALT greater than 3X upper limit of normal

What they're measuring

Treatment-Emergent Adverse Events.

Timeframe: Day 1 to Day 365

Trial details

NCT IDNCT00696124

SponsorHelixmith Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-10-19

Results submitted2024-04-17

View on ClinicalTrials.gov More Critical Limb Ischemia trials