Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01064440 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia
A Phase 2 study, sponsored by Helixmith Co..
- Completed
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
NCT01064440: Completed Phase 2 study, sponsored by Helixmith Co..
NCT01064440 is a Phase 2 study that has completed, run by Helixmith Co.. The registered enrollment target is 52 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01064440, a Phase 2 study, has completed, sponsored by Helixmith Co..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate whether intramuscular injections of VM202 into the calf is safe and effective in the treatment of critical limb ischemia.
Primary Outcome
The number of participants with treatment-emergent adverse events (TEAEs), defined as adverse events occurring after the first injection of Engensis (VM202), was assessed in moderate or high-risk Critical Limb Ischemia subjects.
Interventions
- OTHER Placebo
- BIOLOGICAL Low Dose VM202
- BIOLOGICAL High Dose VM202
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2010-07-09 |
| Est. Completion | 2023-11-17 |
| Phase | Phase 2 |
What the finished NCT01064440 record still lists
NCT01064440 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01064440 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01064440 about?
NCT01064440 is a clinical study titled "Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia". The purpose of this study is to evaluate whether intramuscular injections of VM202 into the calf is safe and effective in the treatment of critical limb ischemia.
What is the current status of trial NCT01064440?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2010-07-09. Estimated completion is 2023-11-17.
What interventions are being tested in trial NCT01064440?
The interventions under investigation include: Placebo (OTHER), Low Dose VM202 (BIOLOGICAL), High Dose VM202 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01064440?
This trial is sponsored by Helixmith Co., which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01064440's enrollment target sits among peer trials
52 1181st of 2000 higher than 811 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02630121 · 52 participants · Phase 4
Effect of Oxymetazoline Hydrochloride in Combination With Fluticasone Propionate on the Apnea Hypopnea Index (AHI) in Subject With Persistent Nasal Congestion and Mild Obstructive Sleep Apnea
- NCT03629171 · 52 participants · Phase 2
Liposome-encapsulated Daunorubicin-Cytarabine and Venetoclax in Treating Participants With Relapsed, Refractory or Untreated Acute Myeloid Leukemia
- NCT04128748 · 52 participants · Phase 1
Liposomal Cytarabine and Daunorubicin (CPX-351) and Quizartinib for the Treatment of Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome
- NCT04150497 · 52 participants · Phase 1
Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI