预约演示
更新于：2026-09-19
Donaperminogene Seltoplasmid
塞多明基
更新于：2026-09-19
概要
基本信息
原研机构 |
非在研机构 |
权益机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
Sequence Code 319545129
来源: *****
关联
27
项与 塞多明基 相关的临床试验NCT07827521
A Multicenter, Randomized, Open-Label, Controlled Trial to Evaluate the Safety and Efficacy of Seltoplasmid Injection Combined With Revascularization for Chronic Limb-Threatening Ischemia Caused by Infrapopliteal Artery Disease in Patients With Diabetes
NCT07023965
Multicenter Cohort Long-term Follow-up Study of Participants From Phase III Clinical Trials of Donaperminogene Seltoplasmid Injection for Critical Limb Ischemia
NCT05968118
A Double-Blind, Randomized, Placebo-Controlled, Single Center Study to Assess the Angiogenesis and Blood Perfusion Effect of NL003 in Patients With Critical Limb Ischemia by PETCT-RGD and MIBI
100 项与 塞多明基 相关的临床结果
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100 项与 塞多明基 相关的转化医学
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100 项与 塞多明基 相关的专利（医药）
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8
项与 塞多明基 相关的文献（医药）2025-06-01JOURNAL OF VASCULAR SURGERY
Hepatocyte growth factor for walking performance in peripheral artery disease
Article
作者: Sufit, Robert ; Parekh, Nishant D ; Kramer, Christopher M ; Ferrucci, Luigi ; Tian, Lu ; Peterson, Charlotte A ; Domanchuk, Kathryn J ; Zhao, Lihui ; Volpe, Nicholas J ; Ismaeel, Ahmed ; Polonsky, Tamar ; Zhang, Dongxue ; Xu, Shujun ; McDermott, Mary M ; Ho, Karen ; Kosmac, Kate ; Lloyd-Jones, Donald ; Leeuwenburgh, Christiaan ; Guralnik, Jack M ; Kibbe, Melina R ; Criqui, Michael H
BACKGROUND:
VM202 is a plasmid encoding two isoforms of hepatocyte growth factor. In preclinical studies, hepatocyte growth factor stimulated angiogenesis and muscle regeneration. This preliminary clinical trial tested the hypothesis that VM202 injections in gastrocnemius muscle would improve walking performance in people with mild to moderate and symptomatic lower extremity peripheral artery disease (PAD).
METHODS:
In a double-blind clinical trial, patients with PAD were randomized to gastrocnemius muscle injections of either 4 mg of VM202 or placebo every 14 days for four treatments. The primary outcome was 6-month change in 6-minute walk distance. Secondary outcomes included 3-month change in treadmill walking time and gastrocnemius muscle biopsy measures. In this preliminary trial, statistical significance was prespecified as a one-sided P value of less than .10.
RESULTS:
Thirty-nine participants with PAD (64.1% Black, 28.2% female) were randomized. Adjusting for age, race, smoking, and baseline performance, VM202 did not improve 6-minute walk at 6-month follow-up, compared with placebo (-13.5 m; 90% confidence interval [CI], -38.5 to +∞). At the 3-month follow-up, VM202 improved the maximum treadmill walking time (+2.38 minutes; 90% CI, +1.08 to +∞; P = .014) and increased central nuclei abundance in gastrocnemius muscle (+5.86; 90% CI, +0.37 to +∞; P = .088), compared with placebo. VM202 did not significantly improve pain-free walking distance (difference, +0.30 minutes; 90% CI, -1.10 to +∞; P = .39), calf muscle perfusion (difference, +1.80 mL/min per 100 g tissue; 90% CI, -3.80 to +∞; P = .33), or the Walking Impairment Questionnaire distance score (difference, +2.02; 90% CI, -8.11 to +∞; P = .40). In post hoc analyses, VM202 significantly improved 6-minute walk in PAD participants with diabetes mellitus at 6-month follow-up (+34.19; 90% CI, 4.04 to +∞; P = .075), but had no effect in people without diabetes (interaction P = .079).
CONCLUSIONS:
These data do not support gastrocnemius injections of VM202 to improve 6-minute walk in PAD. Secondary outcomes suggested potential benefit of VM202 on skeletal muscle measures and treadmill walking, whereas post hoc analyses suggested benefit in PAD participants with diabetes.
2022-09-01Molecular and cellular neurosciences
Gabapentin inhibits the analgesic effects and nerve regeneration process induced by hepatocyte growth factor (HGF) in a peripheral nerve injury model: Implication for the use of VM202 and gabapentinoids for peripheral neuropathy
Article
作者: Nayeon Lee ; Boram Nho ; Sunyoung Kim ; Junghun Lee ; Kyeong Ryang Ko
Hepatocyte growth factor (HGF) is a multifunctional protein that plays a critical role in the angiogenic, neurotrophic, antifibrotic, and antiapoptotic activities of various cell types. It has been previously reported that intramuscular injection of pCK-HGF-X7 (or VM202), a plasmid DNA designed to express both native isoforms of human HGF (Pyun et al., 2010), significantly reduced the level of neuropathic pain in clinical studies as well as in a variety of animal models. In clinical studies, it has been observed that pCK-HGF-X7 appeared to give much higher pain-relieving effects in subjects not taking pregabalin or gabapentin, α2δ1 calcium channel blockers frequently prescribed for reducing pain in patients with diabetic peripheral neuropathy. In this study, we tested the effects of gabapentin on HGF-mediated pain reduction and nerve regeneration in vivo. Consistent with the data from clinical studies, gabapentin administration inhibited the pain reduction and axon regeneration effects mediated by HGF expression from pCK-HGF-X7. In the context of nerve regenerative effects, treatment with gabapentin or EGTA, a Ca2+ chelator, inhibited HGF-mediated axon outgrowth of injured sciatic nerves in vivo. Taken together, i.m. injection of HGF-encoding plasmid DNA ameliorated pain symptoms and enhanced the regeneration of injured nerves, and these therapeutic effects of HGF were significantly hindered by gabapentin treatment, suggesting the possible involvement of Ca2+ in the pro-regenerative activities of native HGF derived from treatment with pCK-HGF-X7.
2022-06-01Biochemical and biophysical research communications3区 · 生物学
Intramuscular injection of a plasmid DNA vector expressing hepatocyte growth factor (HGF) ameliorated pain symptoms by controlling the expression of pro-inflammatory cytokines in the dorsal root ganglion
3区 · 生物学
Article
作者: Lee, Junghun ; Nho, Boram ; Kim, Sunyoung ; Ko, Kyeong Ryang
Hepatocyte growth factor (HGF) is a secretory protein that is involved in various biological activities such as angiogenesis, neuroprotection, and anti-inflammatory effects. Intramuscular injection of an HGF-encoding plasmid DNA (pCK-HGF-X7) has been shown to produce pain-relieving effects in a rodent model and patients with neuropathic pain.To further investigate the underlying mechanism, we investigated the anti-inflammatory effects of HGF in the context of neuropathic pain. Consistent with previous data, intramuscular injection of pCK-HGF-X7 showed pain relieving effects up to 8 weeks and pharmacological blockade of the c-Met receptor hindered this effect, which suggest that the analgesic effect was c-Met receptor-dependent. At the histological level, macrophage infiltration in the dorsal root ganglion (DRG) was significantly decreased in the pCK-HGF-X7 injected group. Moreover, HGF treatment significantly downregulated the LPS-mediated induction of pro-inflammatory cytokines in primary cultured DRG neurons. Taken together, these data suggest that HGF-encoding plasmid DNA attenuates neuropathic pain via controlling the expression of pro-inflammatory cytokines.
379
项与 塞多明基 相关的新闻（医药）2026-09-15
2026-09-14
2026-09-13
100 项与 塞多明基 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 重度下肢缺血 | 中国 | 2026-05-27 | |
| 下肢溃疡 | 中国 | 2026-05-27 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 动脉闭塞性疾病 | 临床3期 | 中国 | 2019-08-02 | |
| 慢性肢体威胁性缺血 | 临床3期 | 中国 | 2019-08-02 | |
| 溃疡 | 临床3期 | 中国 | 2019-08-02 | |
| 糖尿病足溃疡 | 临床3期 | 美国 | 2017-06-27 | |
| 外周动脉疾病 | 临床3期 | 美国 | 2017-06-27 | |
| 糖尿病周围神经性疼痛 | 临床3期 | 美国 | 2016-04-01 | |
| 静息痛 | 临床3期 | 中国 | - | |
| 冠心病 | 临床2期 | - | 2023-06-07 | |
| 糖尿病血管病变 | 临床2期 | - | 2023-06-07 | |
| 糖尿病性神经病变 | 临床2期 | - | 2023-06-07 |
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临床结果
临床结果
适应症
分期
评价
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临床1/2期 | 9 | (Group 1 - 0.5 mg/1 mL) | 範積廠壓窪艱網簾膚鬱 = 窪簾衊蓋糧醖憲憲築範 鹹積壓鑰廠範獵範憲壓 (範築製遞醖糧廠顧選簾, 獵構選憲憲獵壓鏇醖繭 ~ 襯願簾艱憲淵顧獵襯鑰) 更多 | - | 2025-10-03 | ||
(Group 2 - 1.0 mg/2 mL) | 範積廠壓窪艱網簾膚鬱 = 襯獵衊簾襯衊製網襯鹽 鹹積壓鑰廠範獵範憲壓 (範築製遞醖糧廠顧選簾, 壓夢餘鬱積夢夢選觸構 ~ 製膚願繭鹹鏇選鑰餘築) 更多 | ||||||
临床1/2期 | 12 | (Engensis 4 mg) | 鑰蓋壓築鹽築繭製壓襯 = 網製廠製製夢糧膚鏇選 鏇繭醖鏇範遞鑰遞積鑰 (糧膚簾窪遞鹽顧選簾獵, 膚夢鏇獵醖遞鏇糧窪憲 ~ 艱醖構窪鬱製網範鹹齋) 更多 | - | 2025-06-15 | ||
(Engensis 8 mg) | 鑰蓋壓築鹽築繭製壓襯 = 鏇餘糧淵網積壓積淵壓 鏇繭醖鏇範遞鑰遞積鑰 (糧膚簾窪遞鹽顧選簾獵, 蓋糧顧齋齋糧鹽夢築鑰 ~ 製鹹壓觸糧艱齋網積鹹) 更多 | ||||||
临床1/2期 | 39 | 網憲醖醖願構廠築膚願(窪鑰襯壓鹽鹹壓遞鹽鬱): Difference = -13.5 (90.0% CI, -38.5 ~ ∞) | 不佳 | 2025-06-01 | |||
Placebo | |||||||
临床2期 | 8 | (Engensis) | 遞鏇糧衊齋衊鹽鑰鹽範 = 網廠繭窪鹹夢醖憲鬱襯 構顧構積顧觸構憲鑰廠 (窪製範艱膚憲鬱齋製簾, 壓蓋獵蓋顧選製製繭蓋 ~ 獵繭淵願壓淵顧願淵窪) 更多 | - | 2025-05-29 | ||
Placebo (Placebo) | 遞鏇糧衊齋衊鹽鑰鹽範 = 衊鬱鹽淵餘蓋鑰膚憲壓 構顧構積顧觸構憲鑰廠 (窪製範艱膚憲鬱齋製簾, 觸蓋鬱簾淵鹽衊鏇壓醖 ~ 壓餘遞淵廠餘夢範廠積) 更多 | ||||||
临床1/2期 | 12 | 鏇範艱獵醖願選齋糧醖 = 製壓糧願衊壓網鹹遞壓 衊獵蓋鑰壓鑰鬱憲顧鹹 (遞構構鑰憲鹽積夢憲製, 糧憲遞艱簾網蓋範糧製 ~ 膚蓋窪網顧襯獵襯廠簾) 更多 | - | 2025-05-29 | |||
临床3期 | 242 | 獵選夢鹽鏇醖製夢鏇餘(構壓鹽蓋製範顧膚繭衊) = 願顧廠窪鹹艱網糧獵選 夢願顧糧製醖醖鹽遞夢 (網積襯築網鬱範鹹鑰獵 ) | 积极 | 2025-05-12 | |||
安慰剂 | 獵選夢鹽鏇醖製夢鏇餘(構壓鹽蓋製範顧膚繭衊) = 廠遞膚糧醖壓構鹹膚鹹 夢願顧糧製醖醖鹽遞夢 (網積襯築網鬱範鹹鑰獵 ) | ||||||
临床2期 | 18 | (Engensis) | 鑰願壓選襯繭獵願膚淵 = 鹹淵願夢鬱選鹹窪膚憲 壓鑰鑰鏇壓廠鹹壓餘繭 (壓蓋獵齋齋觸積願繭齋, 製簾遞築淵鹽鹹醖築衊 ~ 獵繭壓願淵淵網構壓觸) 更多 | - | 2025-05-06 | ||
Placebo (Placebo) | 鑰願壓選襯繭獵願膚淵 = 齋夢壓鬱構膚遞齋鑰餘 壓鑰鑰鏇壓廠鹹壓餘繭 (壓蓋獵齋齋觸積願繭齋, 願齋願艱鹽鹹網網獵蓋 ~ 範鏇網積鑰願鏇餘壓積) 更多 | ||||||
临床3期 | 302 | 繭鬱廠鏇夢夢蓋鏇膚糧(艱壓蓋鹹鹽願蓋夢夢衊) = 膚選淵夢築獵鏇簾艱簾 積遞構憲築鬱製構膚觸 (蓋鑰醖窪觸遞選範蓋選 ) 达到 更多 | 积极 | 2025-02-23 | |||
Placebo | 繭鬱廠鏇夢夢蓋鏇膚糧(艱壓蓋鹹鹽願蓋夢夢衊) = 齋觸獵蓋鏇淵糧膚窪顧 積遞構憲築鬱製構膚觸 (蓋鑰醖窪觸遞選範蓋選 ) 达到 更多 | ||||||
临床3期 | 162 | (Engensis) | 壓襯獵窪餘糧餘夢觸網(網蓋鑰遞繭觸範遞顧積) = 艱簾顧廠顧網齋衊齋觸 淵襯願蓋築廠醖獵獵蓋 (製鹽糧觸艱築願壓鹹製, 2.020) 更多 | - | 2025-01-20 | ||
Placebo (Placebo) | 壓襯獵窪餘糧餘夢觸網(網蓋鑰遞繭觸範遞顧積) = 艱鏇鏇窪廠願範鹹觸襯 淵襯願蓋築廠醖獵獵蓋 (製鹽糧觸艱築願壓鹹製, 2.115) 更多 | ||||||
临床3期 | 106 | (Engensis) | 鬱鹹築艱積鏇襯齋選鹹(構鹽艱網觸獵窪艱鹽鹹) = 積範齋鹽觸觸憲簾壓艱 觸齋鬱鏇鑰膚襯遞鏇繭 (膚選積鏇壓蓋夢憲鬱淵, 2.083) 更多 | - | 2025-01-16 | ||
Placebo (Placebo) | 鬱鹹築艱積鏇襯齋選鹹(構鹽艱網觸獵窪艱鹽鹹) = 壓壓壓鬱膚繭廠積觸餘 觸齋鬱鏇鑰膚襯遞鏇繭 (膚選積鏇壓蓋夢憲鬱淵, 2.087) 更多 |
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