Safety Study of Gene Therapy in Treating Lower Leg Ischemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00696124|
Recruitment Status : Completed
First Posted : June 12, 2008
Last Update Posted : October 18, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Critical Limb Ischemia||Biological: VM202 2mg Biological: VM202 4mg Biological: VM202 8mg Biological: VM202 16mg||Phase 1|
The study will consist of four (4) cohorts with a total of 3 subjects enrolled in each cohort to VM202.For each dose cohort, VM202 will be administered as a local intramuscular injection in 2 divided doses with a 2-week interval between the injections. Preliminary efficacy (hemodynamic assessments), safety and tolerability will be evaluated at Baseline (screening) and at designated time points throughout the study.
After all subjects in the first dose cohort have completed the 30-day (+ 2 days) follow-up visit following the first dose of the study drug, an interim safety evaluation will be performed with the submission of safety data to the Data Safety Monitoring Committee (DSMC). If the DSMC recommends continuing the study, the second dose cohort will be treated. This process will be repeated between the second and third dose cohort and between the third and fourth dose cohort.
All four dose cohorts will be followed for up to 5 years from the time of the first dose of study drug administration.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1, Dose-Escalation Study to Assess the Safety and Tolerability of VM202 in Subjects With Critical Limb Ischemia|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||May 2010|
Experimental: Cohort 1
2mg dose VM202. The first half of the total dose given on Day 1 and the second half on Day 15.
Biological: VM202 2mg
2mg intramuscular injection with the first half of the total dose given on Day 1 and the second half on Day 15
Experimental: Cohort 2
4mg dose VM202. The first half of the total dose given on Day 1 and the second half on Day 15.
Biological: VM202 4mg
4mg intramuscular injection, with half of the total dose given on Day 1 and the second half given on Day 15
Experimental: Cohort 3
8mg dose VM202. The first half of the total dose given on Day 1 and the second half on Day 15.
Biological: VM202 8mg
8mg intramuscular injection. The first half of the total dose given on Day 1 and the second half on Day 15.
Experimental: Cohort 4
16mg dose VM202. The first half of the total dose given on Day 1 and the second half on Day 15.
Biological: VM202 16mg
16mg dose intramuscular injection. The first half of the total dose given on Day 1 and the second half on Day 15.
- The incidence of adverse events through Day 365. [ Time Frame: Day1 pre-procedure, post procedure days 1, 8, 15 (pre and post procedure), 16, 21, 28, 59, 91, 180, and 365 ]
- Change from baseline in hemodynamic measurements (ABI, TBI and wave form analysis) and TcP02. [ Time Frame: Days 15, 28, 59, 91, 180, and 365 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00696124
|United States, Minnesota|
|Minneapolis Heart Institute Foundation/ Abbott Northwestern Hospital|
|Minneapolis, Minnesota, United States, 55407|
|Principal Investigator:||Timothy Henry, MD||Minneapolis Heart Institute Foundation|