14 completed, 5 withdrawn, 1 terminated. 14 Phase 2, 7 Phase 1, 6 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 14 | Completed 9, Withdrawn 5 |
| Phase 1 | 7 | Completed 5, Withdrawn 2 |
| Phase 3 | 6 | Completed 4, Terminated 1, Withdrawn 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A 6-Month Extension Study to Assess the Long-Term Safety of Engensis in Amyotrophic Lateral Sclerosis Engensis, Placebo - Amyotrophic Lateral Sclerosis | Phase 2 | Completed | Helixmith Co., Ltd. | 8 | 2021-11-14 | 2025-10-06 |
| A 6-Month Extension Study of VMDN-003-2 to Assess Engensis in Participants With Painful Diabetic Peripheral Neuropathy Engensis, Placebo - Diabetic Peripheral Neuropathy | Phase 3 | Completed | Helixmith Co., Ltd. | 106 | 2021-05-17 | 2025-10-09 |
| The Efficacy and Safety of TADIOS as an Adjuvant Therapy in Patients Diagnosed With Mild to Moderate COVID-19 TADIOS, Placebo - COVID-19 | Phase 2 / Phase 3 | Withdrawn | Helixmith Co., Ltd. | 2021-05-06 | 2025-09-25 | |
| Safety of Engensis in Participants With Amyotrophic Lateral Sclerosis Engensis, Placebo - Amyotrophic Lateral Sclerosis | Phase 2 | Completed | Helixmith Co., Ltd. | 18 | 2021-03-09 | 2025-10-06 |
| Study to Assess Safety and Efficacy of Engensis in Painful Diabetic Peripheral Neuropathy Engensis, Placebo - Diabetic Neuropathy, Painful | Phase 3 | Completed | Helixmith Co., Ltd. | 162 | 2020-11-20 | 2025-10-09 |
| The Safety and Tolerability of Engensis (VM202) in Patients With Charcot-Marie-Tooth Disease Subtype 1A (CMT1A) Engensis (VM202) - CMT | Phase 1 / Phase 2 | Completed | Helixmith Co., Ltd. | 12 | 2020-09-21 | 2025-10-06 |
| Extension of Phase 3 Gene Therapy for Painful Diabetic Neuropathy Long-Term Follow-Up of Patients who Received Engensis (VM202), Long-Term Follow-Up of Patients who Received Placebo - Painful Diabetic Neuropathy, Diabetic Neuropathy, Painful | Phase 3 | Completed | Helixmith Co., Ltd. | 101 | 2019-02-04 | 2025-10-09 |
| Safety and Efficacy Study of Gene Therapy for Acute Myocardial Infarction in Korea Stage 1-Low dose VM202RY, Stage 1-Middle dose VM202RY, Stage 1-High dose VM202RY - Ischemic Heart Disease, Acute Myocardial Infarction | Phase 2 | Withdrawn | Helixmith Co., Ltd. | 2018-01-25 | 2025-09-25 | |
| Hepatocyte Growth Factor to Improve Functioning in PAD VM202, Placebo - Peripheral Artery Disease | Phase 2 | Completed | Northwestern University | 39 | 2018-01-01 | 2024-05-30 |
| Safety and Efficacy Study of Engensis (VM202) in the Treatment of Chronic Non-Healing Foot Ulcers Engensis (VM202), Placebo - Foot Ulcer, Diabetic | Phase 3 | Terminated | Helixmith Co., Ltd. | 44 | 2017-06-27 | 2025-10-09 |
| Phase 3 Gene Therapy for Painful Diabetic Neuropathy Engensis (VM202), placebo - Painful Diabetic Neuropathy, Diabetic Neuropathy, Painful | Phase 3 | Completed | Helixmith Co., Ltd. | 507 | 2016-04-01 | 2025-10-09 |
| Gene Therapy for the Treatment of Chronic Stable Angina VM202 - Myocardial Ischemia | Phase 1 / Phase 2 | Withdrawn | Helixmith Co., Ltd. | 2015-03-01 | 2025-09-25 | |
| Safety Study of VM202 to Treat Amyotrophic Lateral Sclerosis VM202 - Amyotrophic Lateral Sclerosis | Phase 1 / Phase 2 | Completed | Helixmith Co., Ltd. | 18 | 2014-03-11 | 2025-10-06 |
| Safety and Efficacy Study for the Treatment of Painful Diabetic Neuropathy Low Dose: 16 mg Engensis (VM202), High Dose: 32 mg Engensis (VM202), Control- Placebo (normal saline) - Painful Diabetic Neuropathies | Phase 2 | Completed | Helixmith Co., Ltd. | 104 | 2012-08-01 | 2025-10-06 |
| Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia Low Dose VM202, High Dose VM202, Placebo - Critical Limb Ischemia | Phase 2 | Completed | Helixmith Co., Ltd. | 52 | 2010-07-09 | 2025-10-06 |
| Gene Therapy for Painful Diabetic Neuropathy VM202 - Painful Diabetic Peripheral Neuropathy | Phase 1 / Phase 2 | Completed | Helixmith Co., Ltd. | 12 | 2010-02-01 | 2025-10-06 |
| Safety Study of Gene Therapy in Treating Critical Leg Ischemia VM202 2 mg, VM202 4 mg, VM202 8 mg - Critical Limb Ischemia | Phase 1 | Completed | Helixmith Co., Ltd. | 12 | 2007-04-03 | 2025-10-06 |
| Safety Study of Gene Therapy for Ischemic Heart Disease in Korea VM202-0.5 mg, VM202-1.0 mg, VM202-2.0 mg - Ischemic Heart Disease | Phase 1 / Phase 2 | Completed | Helixmith Co., Ltd. | 9 | 2007-01-01 | 2025-10-03 |
| Gene Therapy for Chronic Granulomatous Disease in Korea VM106 - Chronic Granulomatous Disease | Phase 1 / Phase 2 | Withdrawn | Helixmith Co., Ltd. | 2007-01-01 | 2025-09-25 | |
| Efficacy and Safety Study of PG201 Tablet in Patients With Osteoarthritis PG201, Placebo - Osteoarthritis of the Knee | Phase 2 | Withdrawn | Helixmith Co., Ltd. | 2006-12-01 | 2025-09-25 |
Diabetic Neuropathies (4) · Amyotrophic Lateral Sclerosis (3) · Myocardial Ischemia (3) · Chronic Limb-Threatening Ischemia (2) · Pain (2) · Peripheral Arterial Disease (2) · Angina Pectoris (1) · COVID-19 (1) · Coronary Disease (1) · Diabetes Mellitus (1) · Diabetic Foot (1) · Foot Ulcer (1) · Granulomatous Disease, Chronic (1) · Hypesthesia (1) · Ischemia (1)
Saline Solution (2) · Genetic Therapy (1) · Hepatocyte Growth Factor (1) · Sodium Chloride (1) · Sucrose (1) · herbal extract PG201 (1)
United States (14) · South Korea (8) · India (1)
John A Kessler, MD (2) · David G Armstrong,, DPM, MD, PhD (1) · Emerson C. Perin, MD (1) · Emerson Perin, MD (1) · Gibong Kim, MD, PhD (1) · Jack Kessler, MD (1) · John A. Kessler, MD (1) · John Kessler, M.D. (1) · John M Paul, MD (1) · Joong Gon Kim, MD, PhD (1) · Mary McDermott, MD (1) · S.H. Park, M.D. (1) · Timothy Henry, MD (1) · Wook Bum Pyun, MD, PhD (1)
PMID 26000320, PMID 33465273, PMID 36588397, PMID 39778757, PMID 41787447
R21AG056903 (1)