Multicenter Cohort Long-term Follow-up Study of Participants From Phase III Clinical Trials of Donaperminogene Seltoplasmid Injection for Critical Limb Ischemia

The goal of this observational study is to learn about the long-term effects of Donaperminogene Seltoplasmid Injection (NL003) in participants who have been received drug NL003 or placebo at least one dose from the parent phase III clinical study to treat their critical limb ischemia (CLI). The main questions it aims to answer are:
* First, what medical problems do participants have after taking drug NL003 to treat CLI?
* Second, does drug NL003 make CLI participants live longer without serious problems (amputations or target vessel revascularizations) ?
Participants who have already received drug NL003 for CLI will complete online surveys about their health conditions. This study will continue until at least 36 months after the participant's first dose.

Start Date30 Jun 2025

Sponsor / Collaborator

Beijing Northland Biotech.Co., Ltd.

CTR20221646

/ CompletedPhase 3

联合 68Ga-RGD PET 和 99mTc-MIBI SPECT 影像学方法评估 NL003 在治疗慢性下肢缺血过程中对血管新生及下肢血流灌注量的影响，评价药物的有效性和安全性。

[Translation] Combined 68Ga-RGD PET and 99mTc-MIBI SPECT imaging methods were used to evaluate the effect of NL003 on angiogenesis and lower limb blood perfusion in the treatment of chronic lower limb ischemia, and to evaluate the efficacy and safety of the drug.

联合 68Ga-RGD PET 和 99mTc-MIBI SPECT 影像学方法评估 NL003 在治疗慢性下肢缺血过程中对血管新生及下肢血流灌注量的影响，评价药物的有效性和安全性。

[Translation]

Combined 68Ga-RGD PET and 99mTc-MIBI SPECT imaging methods were used to evaluate the effect of NL003 on angiogenesis and lower limb blood perfusion in the treatment of chronic lower limb ischemia, and to assess the efficacy and safety of the drug.

Start Date29 Jul 2022

Sponsor / Collaborator

Beijing Northland Biotech.Co., Ltd.

NCT05968118

/ RecruitingPhase 3

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

The purpose of this study is to evaluate whether PET/CT-RGD or MIBI can be used for the angiogenesis assessment of NL003 in PAD patients.

Start Date29 Jul 2022

Sponsor / Collaborator

Beijing Northland Biotech.Co., Ltd.

100 Clinical Results associated with Donaperminogene Seltoplasmid

100 Translational Medicine associated with Donaperminogene Seltoplasmid

100 Patents (Medical) associated with Donaperminogene Seltoplasmid

Literatures (Medical) associated with Donaperminogene Seltoplasmid

01 Aug 2025·TISSUE & CELL

Optimal injection sites for therapeutic angiogenesis: HGF-mediated regulation of HIF-1α via MAPK/PI3K pathways in hypoxic endothelial cells

Article

Author: Wang, Wenjing ; Ni, Leng ; Sun, Guoqiang ; Liu, ChangWei ; Zhong, Qing ; Di, Xiao ; Rong, Zhihua ; Chen, Tianqi ; Qiu, Hongjuan ; Ma, ShanShan ; Lian, Wenzhuo ; Wang, Peng ; Li, Fengshi ; Li, Zongshu

Therapeutic angiogenesis offers a promising strategy for patients with critical limb-threatening ischemia (CLTI) who are unsuitable candidates for revascularization. However, the optimal administration sites for gene therapy agents, such as pCK-HGF-X7, remains undefined. Clinical trials commonly employ multiple intramuscular injections at sites of arterial occlusion; yet the necessity and efficacy of such extensive and repetitive protocols remains unclear. Targeted injections into ischemic tissues or their margins may improve therapeutic outcomes. Moreover, the molecular mechanisms by which hepatocyte growth factor (HGF)/c-Met signaling regulates hypoxia-inducible factor-1α (HIF-1α) expression under hypoxic conditions are not fully understood. This study aims to elucidate these molecular mechanisms in endothelial cells under hypoxic conditions and to identify the most effective injection sites for therapeutic angiogenesis agents. The effects of various HGF isoforms/complexes on human aortic endothelial cells (HAECs) were evaluated under normoxic and hypoxic conditions, focusing on proliferation, migration, and tube formation. Pathway inhibitors were used to explore the underlying mechanisms in hypoxic HAECs, and the findings were validated in a rat hindlimb ischemia model. Results demonstrated that HGF₇₂₃ and HGF₇₂₈ activated the mitogen-activated protein kinase (MAPK) and phosphatidylinositol 3-kinase (PI3K) pathways, regulating HIF expression and significantly enhanced endothelial cell proliferation, migration, and tube formation, particularly under hypoxia. Despite these cellular effects, HGF treatment did not significantly improve tissue perfusion or neovascularization in normal rat hindlimbs. However, in ischemic rat hindlimbs, it markedly promoted angiogenesis and improved tissue perfusion in the gastrocnemius muscle. These findings indicate that therapeutic angiogenesis agents should primarily target hypoxic tissues, extending to the interface between normoxic and hypoxic regions, to optimize treatment efficacy.

01 Jun 2025·JOURNAL OF VASCULAR SURGERY

Hepatocyte growth factor for walking performance in peripheral artery disease

Article

Author: 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 ; Ho, Karen ; McDermott, Mary M ; Xu, Shujun ; Kosmac, Kate ; Lloyd-Jones, Donald ; Leeuwenburgh, Christiaan ; Kibbe, Melina R ; Guralnik, Jack M ; 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.

01 Nov 2023·International wound journal

Gene therapy for diabetic foot ulcers: Interim analysis of a randomised, placebo‐controlled phase 3 study of VM202 (ENGENSIS), a plasmid DNA expressing two isoforms of human hepatocyte growth factor

Article

Author: Cyaandi Dove ; David G Armstrong ; Lacey Loveland ; Mher Vartivarian ; Felix Sigal ; Joseph Caporusso ; Emerson Perin ; Francisco Oliva ; Travis Motley ; the VMNHU-003 study group

Abstract:

To evaluate the status of a 7‐month phase 3 study conducted to test the effect of intramuscular injections of VM202 (ENGENSIS), a plasmid DNA encoding human hepatocyte growth factor, into the calf muscles of chronic nonhealing diabetic foot ulcers with concomitant peripheral artery disease. The phase 3 study, originally aimed to recruit 300 subjects, was discontinued because of slow patient recruitment. An unprespecified interim analysis was performed for the 44 subjects enrolled to assess the status and determine the future direction. Statistical analyses were carried out for the Intent‐to‐Treat (ITT) population and separately for subjects with neuroischemic ulcers, using a t‐test and Fisher's exact test. A logistic regression analysis was also conducted. VM202 was safe and potentially should have benefits. In the ITT population (N = 44), there was a positive trend toward closure in the VM202 group from 3 to 6 months but with no statistical significance. Levels of ulcer volume or area were found to be highly skewed between the placebo and VM202 groups. Forty subjects, excluding four outliers in both arms, showed significant wound‐closing effects at month 6 (P = .0457). In 23 patients with neuroischemic ulcers, the percentage of subjects reaching complete ulcer closure was significantly higher in the VM202 group at months 3, 4, and 5 (P = .0391, .0391, and .0361). When two outliers were excluded, a significant difference was evident in months 3, 4, 5, and 6 (P = .03 for all points). A potentially clinically meaningful 0.15 increase in Ankle‐Brachial Index was observed in the VM202 group at day 210 in the ITT population (P = .0776). Intramuscular injections of VM202 plasmid DNA to calf muscle may have promise in the treatment of chronic neuroischemic diabetic foot ulcers (DFUs). Given the safety profile and potential healing effects, continuing a larger DFU study is warranted with modifications of the current protocol and expansion of enrolling sites.

News (Medical) associated with Donaperminogene Seltoplasmid

04 Oct 2022

·www.prnewswire.com

Helixmith to Present New ALS-Focused Development Program at Upcoming Conferences

LA JOLLA, Calif., Oct. 4, 2022 /PRNewswire/ -- Helixmith announced today that their CEO, Dr. Sunyoung Kim, will be presenting an overview of their ALS-focused program, named DART, Defeating ALS through Regenerative Therapeutics, at both the 2022 Cell & Gene Meeting on the Mesa and the 2022 BIO-Europe Conference. DART is unique in that it capitalizes on cell signaling pathways important in ALS pathogenesis and that three modalities are being investigated virtually simultaneously for ALS. The first DART platform utilizes HGF/c-Met signaling pathway. Hepatocyte Growth Factor (HGF) is a multifunctional factor associated with neurotrophic, anti-fibrotic, anti-inflammatory and angiogenic activities. Its receptor, c-Met, is present in all major cell types important in ALS, including motor neurons, inflammatory macrophages, and skeletal muscles (such as the diaphragm and accessory muscles of respiration). Data from pre-clinical research demonstrated that HGF/c-Met signaling could produce strong anti-neuroinflammatory effects as well as promote axon outgrowth and motor neuron survival, restoring damaged upper and spinal motor neurons (UMN, SMN) and neuromuscular junction (NMJ), and improve muscle atrophy and motor functions. The rationale of such a multi-modal parallel approach is as follows: First, the cause of most ALS cases is unknown. Therefore, it is unlikely that the deployment of a single molecule (whether it be a small molecule or a biologic) will effectively treat all ALS cases, even if it were to work for a subset of patients. Helixmith is hence using an HGF that binds to key cell types involved in ALS pathogenesis, including motor neurons, macrophages, and skeletal muscles. Second, it takes nearly 10 years to develop one drug candidate and have it tested in a phase 1 clinical trial. If Helixmith was to start working on the second product only after the first candidate fails, this is too slow for ALS patients' urgent need for treatment. Therefore, Helixmith is testing three products almost simultaneously. Their aim is to get the results from the three clinical programs, including the phase 1 and phase 2 trials, within 5 years. In DART, three modalities (plasmid DNA, AAV, and humanized antibodies) are being investigated, in parallel, at both clinical and pre-clinical stages. Helixmith recently completed a Phase 1 and a Phase 2a clinical trial using Plasmid DNA-encoding HGF modality (Engensis or VM202). A small-scale phase 1/2 is planned in which plasmid DNA will be injected into the muscles involved in respiration, including the diaphragm. Having obtained encouraging data on survival rates, motor neuron function, and motor function in animal models, an optimized AAV vector modality (NM301) has also been developed for clinical studies. Additionally, a fully humanized antibody modality (VM507) that binds to c-Met receptors and activates signaling has shown its effectiveness in a variety of disease models. The AAV and antibody modalities will be tested in phase 1 studies between 2024 and 2026. Helixmith has the funding for a clinical study testing the effect of VM202 on respiration in ALS patients. To achieve their goal to complete clinical studies with two other modalities, Helixmith will need to raise additional capital. The following are specific details regarding Helixmith's presentation at the two conferences: Dr. Kim's Presentation is available on-demand to conference registrants at . About Helixmith Helixmith is a clinical-stage gene therapy company headquartered in Seoul, Korea, developing new and innovative biopharmaceuticals to address previously untreated diseases, and is listed on the KOSDAQ. The company has an extensive gene therapy pipeline including a CAR-T program targeting several different types of solid tumors and an AAV vector program targeting neuromuscular diseases. Engensis (VM202), the most advanced pipeline candidate, is a plasmid DNA therapy being studied for diabetic foot ulcers (DFU), claudication, amyotrophic lateral sclerosis (ALS), and diabetic peripheral neuropathy (DPN). Media Contact: Jennifer Guzman [email protected] 7602917245 SOURCE Helixmith USA Inc.

Gene TherapyAntibodySmall molecular drug

06 Sep 2022

·www.prnewswire.com

Helixmith Announces Topline Results from Phase 2A Study of Engensis for Treatment of ALS (Amyotrophic Lateral Sclerosis)

LA JOLLA, Calif., Sept. 6, 2022 /PRNewswire/ -- Helixmith announced topline results today from a Phase 2A study in individuals with ALS (Amyotrophic Lateral Sclerosis). ALS is a fatal neurodegenerative disorder of upper and lower motor neurons that causes progressive paralysis and eventual death due to respiratory failure. This Phase 2A was a double-blind placebo controlled multi-center study involving 5 sites (4 in the US and 1 in Korea) and 18 subjects randomized to a 2:1 ratio of Engensis to placebo. In this Phase 2A study, three treatments of Engensis, a plasmid DNA encoding human HGF, or placebo were injected in the upper and lower limbs on months 0, 2 and 4. One treatment consisted of two cycles of injections, on 2-week intervals, of 64 mg of Engensis or placebo in total. Therefore, a total of 192 mg of Engensis was given to each subject over a 4-month period. In addition, there was a follow-up period of 6 months after the first injection on Day 0. The results of the study demonstrated that Engensis was safe and well tolerated at this dosing regimen. There was no difference in the frequency of TEAEs (83% for each group) between the Engensis and the placebo groups. One TEAE, bronchitis, was reported in the Engensis group but was determined to not be related to the study drug. Injection site reactions were reported by 50% of the Engensis group and by 66.7% of the placebo group. Most of the injection site reactions were Grade 1 or 2 and resolved within a short time, and none of the participants in the study discontinued due to the number of injections. These data suggest that high dose, repeated treatments of Engensis, were safe and well tolerated, providing a great deal of flexibility in designing dosing schemes for future clinical studies. Given the primary endpoint of this study was to test safety and tolerability, efficacy was measured only as an exploratory parameter. ALSFRS-R scores, muscle functions using handheld dynamometry, and ALSAQ-40 were among the measurements collected. Since the study size was small and 4 subjects dropped out early, we were unable to compare efficacy between the Engensis and placebo groups. An important component of this study was the collection of biopsy samples from the participants' injections sites. Engensis is an intramuscularly delivered gene therapy. The bulk of the data collected to date, showing effects of HGF expressed from Engensis, has been from animal models. Data collected from clinical trials has been limited thus far. Thanks to our dedicated clinical trial participants, muscle biopsy samples were collected during the course of the trial and will be subjected to histological and molecular biological analyses using RNA-Seq. Helixmith greatly appreciates the generous and eager participation of the ALS patients. Data from these results are expected to provide valuable information on the understanding of the mechanisms of actions of Engensis, and its effects on the expression of human genes, which will greatly help in the development of innovative medicines based on HGF/c-Met signaling. Helixmith will continue the analysis of the Phase 2A data upon the receipt of the full report and plan to present results at a future conference and determine next steps for Engensis in ALS at that time. About Helixmith Helixmith is a clinical-stage gene therapy company headquartered in Seoul, Korea, developing new and innovative biopharmaceuticals to address previously untreated diseases, and is listed on the KOSDAQ. The company has an extensive gene therapy pipeline, including a CAR-T program targeting several different types of solid tumors and an AAV vector program targeting neuromuscular diseases. Engensis (VM202), the most advanced pipeline candidate, is a plasmid DNA therapy being studied for painful diabetic peripheral neuropathy, diabetic foot ulcers, claudication, amyotrophic lateral sclerosis, coronary artery disease, and Charcot-Marie-Tooth disease. SOURCE Helixmith USA Inc.

Gene Therapy

14 Mar 2022

·www.biospace.com

Paper Reporting Results from Helixmith's Phase 3 Gene Therapy Trial for Painful Diabetic Neuropathy was One of the Top-10 Most-Downloaded Articles in Clinical and Translational Science

Helixmith announced today that their publication, "Gene therapy for diabetic neuropathy: A randomized, placebo-controlled phase III study of VM202, a plasmid DNA encoding human hepatocyte growth factor," was one of the top-10 most-downloaded articles in Clinical and Translational Science (CTS) in 2021. CTS is the official publication of the American Society for Clinical Pharmacology & Therapeutics (ASCPT) and highlights original research that helps bridge laboratory discoveries with the diagnosis and treatment of human diseases. Dr. John Kessler, Professor of Neurology at Northwestern was the lead author on this study. This was the first gene therapy phase 3 that has ever been done for pain. According to Alethea Gerding, Managing Editor, ASCPT, "The article has been downloaded more than 3,000 times, meaning that it has reached a wide-ranging worldwide readership. The primary goal of CTS is to become the beacon of translational science, and articles such as yours clearly show the value of translational science." According to Alethea Gerding, Managing Editor, ASCPT, "The article has been downloaded more than 3,000 times" In the paper, VM202 (donaperminogene seltoplasmid), a plasmid DNA encoding the human HGF (hepatocyte growth factor) gene, developed by Helixmith Co. Ltd, authors reported that in VMDN-003b, intramuscular injections of VM202 provided pain reduction for more than 8 months after the last cycle of treatment and that the safety and tolerability was highly favorable, consistent with previous studies. One of the most clinically important findings in both VMDN-003b and the phase II study is that VM202 was more effective in subjects not on pregabalin or gabapentin, two of the most prescribed medicine in the DPN field. These results have important clinical implications as more than 4.2 million people in the US are known to suffer from painful DPN and nearly 1.3 million patients are considered to be refractory, meaning currently available medications do not work for them (Painful Diabetic Neuropathy, GlobalData 2018). Helixmith launched a second phase 3 trial for DPN, REGAiN-1A (VMDN-003-2), in the US and are targeting release of top line results by the end of 2022. The company is planning to start a third phase 3 for DPN in the second half of 2022.

Donaperminogene SeltoplasmidHelixmith Co., Ltd.Diabetic NeuropathiesGene Therapy

100 Deals associated with Donaperminogene Seltoplasmid

R&D Status

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Indication	Country/Location	Organization	Date
Critical lower limb ischemia	China	Beijing Northland Biotech.Co., Ltd.	27 May 2026
Leg Ulcer	China	Beijing Northland Biotech.Co., Ltd.	27 May 2026

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Arterial Occlusive Diseases	Phase 3	China	Beijing Northland Biotech.Co., Ltd.	02 Aug 2019
Chronic Limb-Threatening Ischemia	Phase 3	China	Beijing Northland Biotech.Co., Ltd.	02 Aug 2019
Ulcer	Phase 3	China	Beijing Northland Biotech.Co., Ltd.	02 Aug 2019
Diabetic foot ulcer	Phase 3	United States	Helixmith Co., Ltd.	27 Jun 2017
Peripheral Arterial Disease	Phase 3	United States	Helixmith Co., Ltd.	27 Jun 2017
Diabetic peripheral neuropathic pain	Phase 3	United States	Helixmith Co., Ltd.	01 Apr 2016
Diabetic Nephropathies	Phase 3	China	Beijing Northland Biotech.Co., Ltd.	-
Diabetic Nephropathies	Phase 3	-	Viromed, Inc.	-
Rest pain	Phase 3	China	Beijing Northland Biotech.Co., Ltd.	-
Coronary Artery Disease	Phase 2	-	REYON PHARMACEUTICAL Co., Ltd.	07 Jun 2023

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01422772 (Engensis, CTgov)	Phase 1/2	Myocardial Ischemia	9	VM202 (Engensis) (Group 1 - 0.5 mg/1 mL)	pineuyimdh = xmjckrowiu gsykpykqal (wgrbynefge, juhlnzsgwa - akpipwqxyk) View more	-	03 Oct 2025
				VM202 (Engensis) (Group 2 - 1.0 mg/2 mL)	pineuyimdh = pihxsgqogv gsykpykqal (wgrbynefge, nncaaacxgq - mnzakhrnyf) View more
NCT01002235 (CTgov)	Phase 1/2	Diabetic peripheral neuropathic pain	12	Engensis (VM202) (Engensis 4 mg)	xxiwaffetl = btsvfwjfxr barnfkiruy (fwsqhzvccx, zhdnimvsbe - hozadrskgh) View more	-	15 Jun 2025
				Engensis (VM202) (Engensis 8 mg)	xxiwaffetl = jjrtpovbqp barnfkiruy (fwsqhzvccx, siuhfeerku - ywxfvwwjbv) View more
NCT03363165 (Pubmed \| J Vasc Surg)	Phase 1/2	Peripheral Arterial Disease	39	VM202 4 mg	zocqrdkxmx(wrqmdwebgj): Difference = -13.5 (90.0% CI, -38.5 to ∞)	Negative	01 Jun 2025
				Placebo
NCT05361031 (CTgov)	Phase 1/2	Charcot-Marie-Tooth Disease, Type Ia	12	VM202	ymsuilucwy = pfkxyncnjc cbojnorbyu (wfzquddemc, lpxktoonxy - lwqkivvprf) View more	-	29 May 2025
NCT05176093 (REViVALS-1B, CTgov)	Phase 2	Amyotrophic Lateral Sclerosis	8	Engensis (Engensis)	rgpyvipmar = xovchjkmnz cgxlacylcq (aagusiokee, nrjkfdriuk - tyarbonnpm) View more	-	29 May 2025
				Placebo (Placebo)	rgpyvipmar = gnfagczrso cgxlacylcq (aagusiokee, urbblzgtuu - xcbbtvyfed) View more
NCT04274049 (HOPE CLTI-2, Company_Website) Manual	Phase 3	Critical lower limb ischemia	242	塞多明基注射液	dldqqeixot(ujowfejhax) = rpgjmfihhd wunuiaqfrz (atsfxxzxhk )	Positive	12 May 2025
				安慰剂	dldqqeixot(ujowfejhax) = qkvautvzhc wunuiaqfrz (atsfxxzxhk )
NCT04632225 (REViVALS-1A, CTgov)	Phase 2	Amyotrophic Lateral Sclerosis	18	Engensis (Engensis)	dggrapwwzf = pbpwsuuphj wlamkrbbxw (nyvvxnmnqp, jtqgumcgqc - bkvhxqwnxl) View more	-	06 May 2025
				Placebo (Placebo)	dggrapwwzf = rktlsqohua wlamkrbbxw (nyvvxnmnqp, vwsnztfwdd - maivwpkegg) View more
NCT04275323 (NL003-CLI-III-1, NEWS) Manual	Phase 3	Lower limb ischemia	302	NL003	cpqizyvaif(tywwcphzce) = gcehvtziem igmqmplbxh (nafalshysf ) Met View more	Positive	23 Feb 2025
				Placebo	cpqizyvaif(tywwcphzce) = orldkdkmhz igmqmplbxh (nafalshysf ) Met View more
NCT04469270 (REGAiN-1A, CTgov)	Phase 3	Diabetic peripheral neuropathic pain	162	Engensis (Engensis)	ggktsxqxsf(xnmaxnxswy) = jxtmljjifg dbawfyikhr (przmfznksp, 2.020) View more	-	20 Jan 2025
				Placebo (Placebo)	ggktsxqxsf(xnmaxnxswy) = wglszqnlki dbawfyikhr (przmfznksp, 2.115) View more
NCT04873232 (REGAiN-1B, CTgov)	Phase 3	Diabetic peripheral neuropathic pain	106	Engensis (Engensis)	sejzmlhqgv(idnworhuis) = futumtrskm ptegsprodz (ofdiusjycd, 2.083) View more	-	16 Jan 2025
				Placebo (Placebo)	sejzmlhqgv(idnworhuis) = uyknvitssr ptegsprodz (ofdiusjycd, 2.087) View more

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