商务合作
动脉网APP
可切换为仅中文
Randomized, placebo-controlled study shows over 76% of treated cats demonstrated improved quality of life
随机、安慰剂对照研究表明,超过76%的治疗猫生活质量得到改善
SAN DIEGO
圣地亚哥
,
,
April 15, 2026
2026年4月15日
/PRNewswire/ --
/PRNewswire/ --
Gallant
勇敢的
, an animal health biotechnology company pioneering off-the-shelf stem cell therapies for pets, today announced positive results from a pilot clinical study evaluating intravenous (IV) uterine-derived mesenchymal stromal cell (UMSC) therapy in cats with naturally occurring osteoarthritis (OA). Additionally, the U.S.
,一家致力于为宠物提供现成干细胞疗法的动物健康生物技术公司,今天宣布了一项初步临床研究的积极结果,该研究评估了静脉注射(IV)子宫源间充质基质细胞(UMSC)治疗自然发生的骨关节炎(OA)的猫。此外,美国。
Food and Drug Administration's Center for Veterinary Medicine (FDA-CVM) granted eligibility for the expanded conditional approval pathway for Gallant's feline OA therapy, allowing a faster pathway to market for a product that addresses a significant unmet medical need, ensuring target animal safety and cGMP-quality manufacturing while full effectiveness is being confirmed..
美国食品药品监督管理局兽药中心(FDA-CVM)批准了Gallant的猫科动物骨关节炎治疗药物进入扩展的有条件审批通道,这将为满足重要未满足医疗需求的产品提供更快的上市途径,同时在全面确认疗效的过程中确保目标动物的安全以及符合cGMP标准的生产质量。
Continue Reading
继续阅读
Cat at the veterinarian
兽医处的猫
OA affects 90% of older cats, resulting in increased pain and decreased mobility, which negatively impacts physical appearance, energy and vitality, mood, sociability and physical and mental wellbeing. Caregivers report that the burden of medically managing feline OA surpasses that of other chronic debilitating feline diseases including cancer, heart disease, and diabetes mellitus.
骨关节炎影响90%的老年猫,导致疼痛增加和活动能力下降,对身体外观、精力与活力、情绪、社交能力以及身心健康产生负面影响。照顾者报告称,管理猫骨关节炎的医疗负担超过了其他慢性衰弱性猫科疾病,包括癌症、心脏病和糖尿病。
Medications currently on the market only target the symptoms of OA by blocking inflammatory and pain pathways; however, the immunomodulatory properties of MSCs allow them to target the root cause of disease, potentially offering a disease-modifying therapy..
目前市场上的药物只能通过阻断炎症和疼痛通路来针对骨关节炎的症状;然而,间充质干细胞的免疫调节特性使它们能够针对疾病的根本原因,可能提供一种改变病程的治疗方法。
In a randomized, masked, placebo-controlled study across six U.S. veterinary clinics, 35 client-owned cats with radiographically confirmed OA received two IV injections of either low-dose (5 million cells), high-dose (20 million cells), or saline placebo, administered 14 days apart. The cats were evaluated over 90 days by veterinarians and cat parents..
在一项横跨美国六个兽医诊所的随机、盲法、安慰剂对照研究中,35只经放射学确认患有骨关节炎(OA)的客户拥有的猫接受了两次静脉注射,分别是低剂量(500万个细胞)、高剂量(2000万个细胞)或生理盐水安慰剂,两次注射间隔14天。这些猫在90天内由兽医和猫主人进行了评估。
Overall, the pilot study findings support that IV UMSC therapy is well tolerated in cats with naturally occurring OA. Results showed statistically significant and clinically relevant improvement across both cat parent-reported and veterinarian-assessed outcomes.
总体而言,初步研究结果支持静脉注射UMSC治疗在自然发生的骨关节炎猫中具有良好的耐受性。结果显示,在猫主人报告和兽医评估的结果中,均出现了统计学上显著且临床相关的改善。
Three months following treatment:
治疗后三个月:
Cat's quality of life as assessed by the cat parent using a validated tool (client-specific outcome measure; CSOM):
猫的生活质量由猫主人使用经过验证的工具(客户特定结果测量;CSOM)评估:
76.2% of treated cats improved vs. 36.4% placebo
76.2%的治疗猫只改善,而安慰剂组为36.4%
Cat's overall quality of life as assessed by the cat parent:
猫家长评估的猫的整体生活质量:
81% of treated cats improved vs. 36.4% placebo
81%的治疗猫只改善,而安慰剂组为36.4%
Cat's pain scores assessed by the veterinarian:
兽医评估的猫的疼痛评分:
81% of treated cats improved vs. 45.5% placebo
81%的治疗猫只改善,对比45.5%的安慰剂组
Cat's overall quality of life as assessed by the veterinarian:
兽医评估的猫的整体生活质量:
60% of treated cats improved vs. 20% placebo
60%的治疗猫只改善,而安慰剂组为20%
The results of the 90-day study have been submitted for publication. A continuation study evaluating safety and efficacy of the low-dose therapy out to one year is ongoing.
为期 90 天的研究结果已提交发布。目前正在开展一项延续性研究,评估低剂量治疗长达一年时间的安全性和有效性。
'This data marks additional meaningful progress toward a new category of care, where regenerative medicine targets disease at its source,' said Dr. Linda Black, DVM, Ph.D., CEO of Gallant. 'Osteoarthritis remains a significant burden for cats and their families, and current treatments largely manage symptoms rather than addressing the underlying joint pathology.
“这些数据标志着在迈向一个全新护理类别的过程中取得了更多有意义的进展,再生医学能够从源头上针对疾病,”Gallant首席执行官琳达·布莱克博士(Linda Black,DVM,Ph.D.)说道。“骨关节炎对猫及其家庭来说仍然是一个重大负担,而目前的治疗方法大多只是缓解症状,而不是解决潜在的关节病理问题。”
As we continue to study duration of effect for feline OA, we're encouraged about the potential to deliver long-lasting relief - particularly given results from our refractory feline chronic gingivostomatitis program, where two-thirds of cats showed a positive response one year post-treatment.'.
随着我们继续研究猫科动物骨关节炎的疗效持续时间,我们对提供持久缓解的潜力感到鼓舞——尤其是鉴于我们的难治性猫科动物慢性龈口炎项目的结果,其中三分之二的猫在治疗一年后显示出积极反应。
A Focus on Felines
聚焦猫科动物
Gallant's pipeline reflects a deliberate focus on feline medicine - a historically
加兰特的管道反映出对猫科医学的刻意关注——这是一个历史上
underserved
服务不足的
area of veterinary therapeutics.
兽医治疗学领域。
'Felines have long been overlooked in medical research and therapeutic development, leaving a significant gap in care for a population that deserves far more attention,' said Dr. Rebecca Windsor, vice president of Veterinary Affairs at Gallant. 'Our mission at Gallant is to change that. By advancing cutting-edge regenerative therapies specifically for cats, we aim to lead a new era of innovation that brings meaningful, feline-specific solutions to this underserved community.'.
“长期以来,猫科动物在医学研究和治疗开发中一直被忽视,导致这个应受到更多关注的群体在护理方面存在显著空白,”Gallant兽医事务副总裁丽贝卡·温莎博士表示。“我们在Gallant的使命就是改变这一现状。通过推进针对猫科动物的尖端再生疗法,我们旨在引领一个创新的新时代,为这个服务不足的群体带来有意义且专属于猫的解决方案。”
The feline OA therapy represents the company's second stem cell therapy for cats, building on momentum toward anticipated conditional approval of the potential first-ever FDA-approved, off-the-shelf IV stem cell therapy — sonruvetcel injectable suspension for cats with refractory Feline Chronic Gingivostomatitis (rFCGS) — expected later this year.
猫科动物OA疗法是该公司继今年晚些时候有望获得首个FDA批准的现成静脉注射干细胞疗法——用于治疗难治性猫慢性龈口炎(rFCGS)的Sonruvetcel注射悬液——之后,针对猫的第二种干细胞疗法。
Together, these programs underscore Gallant's commitment to expanding the spectrum of care for cats..
这些项目共同强调了Gallant致力于扩展猫咪护理的范围。
The company's pipeline also includes programs in canine osteoarthritis, feline chronic kidney disease, and canine atopic dermatitis, as well as others.
公司的研发管线还包括针对犬骨关节炎、猫慢性肾病和犬特应性皮炎的项目,以及其他项目。
For information on Gallant's Feline OA pilot study data, go to:
要获取 Gallant 的猫科动物 OA 试点研究数据的信息,请访问:
https://bit.ly/481sItp
https://bit.ly/481sItp
About Gallant
关于加兰特
Gallant is an animal health biotechnology company creating a new category of veterinary care with a pipeline of off-the-shelf, ready-to-use stem cell therapies targeting the root cause of disease in pets. Led by pioneers in veterinary regenerative medicine with deep expertise in development, manufacturing, and commercialization, Gallant is making regenerative medicine accessible - moving beyond symptom management to restoring health at the source.
Gallant是一家动物健康生物技术公司,通过一系列现成的、可立即使用的干细胞疗法,开创了一种全新的兽医护理类别,这些疗法针对宠物疾病的根源。Gallant由兽医再生医学领域的先驱者领导,他们在研发、生产和商业化方面拥有深厚的专业知识,致力于使再生医学变得可及——超越症状管理,从源头恢复健康。
Learn more at .
了解更多,请访问。
www.gallant.com
www.gallant.com
.
。
Media Contact
媒体联系人
Julie Lawless
朱莉·劳莱斯
LawlessComms
无法律通讯
[email protected]
电子邮件地址
+1 615.585.5861
+1 615.585.5861
Gallant's uterine-derived mesenchymal stromal cell therapy for feline osteoarthritis is an investigational new animal drug and has not received FDA approval or conditional approval. Availability is pending regulatory review.
Gallant的子宫源性间充质基质细胞疗法用于猫骨关节炎是一种试验性的新动物药物,尚未获得FDA的批准或有条件批准。可用性有待监管审查。
SOURCE Gallant
来源:Gallant
21
21
%
%
more press release views with
更多新闻稿浏览量与
Request a Demo
请求演示