SUZHOU, China

中国苏州

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，

April 14, 2026

2026年4月14日

/PRNewswire/ -- In April 2026, XellSmart officially launches its multicenter Phase II registrational clinical trial of the 'Clinical-Grade, Allogeneic, Off-the-Shelf, iPSC-Derived, Dopaminergic Neural Progenitor Cell Therapy (XS411) for Primary Parkinson's Disease'. The trial continues to be led by Beijing Tiantan Hospital affiliated to Capital Medical University — a National Center for Neurological Disorders, and is again jointly conducted with Peking Union Medical College Hospital, the Second Affiliated Hospital of Soochow University, and more top-tier hospitals.

/PRNewswire/ -- 2026年4月，XellSmart正式推出其“临床级、同种异体、现货型、iPSC衍生的多巴胺能神经祖细胞疗法（XS411）用于原发性帕金森病”的多中心II期注册临床试验。该试验继续由首都医科大学附属北京天坛医院（国家神经系统疾病临床研究中心）主导，并再次联合北京协和医院、苏州大学附属第二医院及其他顶级医院共同开展。

The advance into Phase II trial in less than one year — from 2025 when the Phase I trial commenced with the first transplantation performed at Beijing Tiantan Hospital, is underpinned by positive Phase I results:.

从2025年一期试验开始，并在北京天坛医院完成首次移植手术，到进入二期试验不到一年的时间——这一进展得益于一期试验的积极结果：。

Professor Feng Tao, the leading PI from Beijing Tiantan Hospital, stated:'The Phase I study primarily evaluated safety, tolerability, and early efficacy signals, and we have confirmed preliminarily that this novel therapy is safe and effective.'

北京天坛医院首席研究员冯涛教授表示：“I 期研究主要评估安全性、耐受性和早期疗效信号，我们初步确认这种新型疗法安全有效。”

Professor Feng Tao further explained the Phase II trial design:'Phase II will adopt a prospective, randomized, standard treatment–parallel controlled design with blinded endpoint assessment. The trial plans to enroll 30 patients aged 50–75 years with a clinically confirmed diagnosis of primary Parkinson's disease and a disease duration of 5 to 15 years.

冯涛教授进一步解释了二期试验设计：“二期试验将采用前瞻性、随机、标准治疗-平行对照设计，并对终点进行盲法评估。试验计划招募30名年龄在50-75岁之间，经临床确诊为原发性帕金森病且病程在5到15年之间的患者。”

They will be randomized to the experimental and control groups in a 2:1 ratio..

他们将以 2:1 的比例被随机分配到实验组和对照组。

In the first stage, the experimental group will receive iPSC-derived cell therapy, while the control group will receive standard anti-Parkinsonian pharmacotherapy. All participants will be followed for 12 months to further evaluate the efficacy and safety of the treatment.

在第一阶段，实验组将接受 iPSC 衍生的细胞治疗，而对照组将接受标准的抗帕金森病药物治疗。所有参与者将在接下来的 12 个月中接受随访，以进一步评估治疗的有效性和安全性。

After completing the 12-month assessment, the experimental group will continue to be followed for an additional year, up to 24 months post-transplantation. Participants in the control group will undergo a second evaluation and, if eligible, may receive XS411 treatment in subsequent follow-up.

在完成12个月的评估后，实验组将继续接受额外一年的随访，直至移植后24个月。对照组的参与者将接受第二次评估，并且如果符合条件，可能在后续随访中接受XS411治疗。

The Phase II trial will further address key scientific questions regarding the efficacy and safety of this stem cell transplantation technology, lay a solid foundation for the Phase III registrational trial, and provide more robust scientific evidence to support the clinical translation of this innovative therapeutic modality.'.

II 期试验将进一步解决关于该干细胞移植技术有效性和安全性的关键科学问题，为 III 期注册试验奠定坚实基础，并为这种创新治疗方式的临床转化提供更加有力的科学证据。

Positive Phase I Results

第一阶段阳性结果

Multiple patients with moderate to severe Parkinson's disease, who were enrolled in the Phase I registrational trial of XS411 — a clinical–grade, allogeneic, off–the–shelf, iPSC–derived, dopaminergic neural progenitor cell therapy for primary Parkinson's disease — at Beijing Tiantan Hospital and its collaborative centers, after follow-up, have achieved significant improvements across multiple core motor indicators following a single transplantation of XS411, with no adverse events related to the transplanted stem cells observed..

多名中重度帕金森病患者在北京天坛医院及其合作中心参与了XS411的I期注册临床试验——这是一种用于原发性帕金森病的临床级、同种异体、现货型、iPSC衍生的多巴胺能神经祖细胞疗法。在随访中发现，这些患者在接受单次XS411移植后，多个核心运动指标均取得了显著改善，且未观察到与移植干细胞相关的不良事件。

-  In terms of efficacy, multiple follow-up assessments following iPSC-derived cell implantation demonstrated significant improvements in key motor outcomes among enrolled patients relative to pre-transplant baseline. These improvements included the MDS-UPDRS Part III motor score in the 'OFF' state, duration of 'ON' time without troublesome dyskinesia (favorable 'ON' time), and daily quality-of-life scores.

在疗效方面，多次随访评估显示，接受iPSC衍生细胞移植的患者在关键运动功能结果上较移植前基线有显著改善。这些改善包括“关”状态下MDS-UPDRS第三部分运动评分、无明显异动症困扰的“开”时间（良好“开”时间）以及每日生活质量评分。

The degree of improvement was markedly higher than the internationally accepted threshold for clinically meaningful change. Notably, the 'OFF' state describes the period when medication effects subside and patients experience motor impairment, while the 'ON' state refers to the phase when medication is effective and patients are able to move relatively freely.

改善的程度明显高于国际公认的临床意义变化的阈值。值得注意的是，“关闭”状态描述的是药物效果减退、患者出现运动障碍的时期，而“开启”状态是指药物有效、患者能够相对自由活动的阶段。

Overall, these improvements enable patients to enjoy significantly longer periods of high-quality daily function..

总体而言，这些改进使患者能够享受更长时间的高质量日常功能。

-  In terms of objective imaging evidence, 18F-DOPA PET-CT molecular imaging performed after treatment revealed a significant increase in 18F-DOPA uptake in the putamen compared with pre-transplant baseline, demonstrating markedly enhanced signal intensity from newly generated dopaminergic neurons in the putamen.

- 在客观影像学证据方面，治疗后进行的18F-DOPA PET-CT分子影像显示，与移植前基线相比，壳核中的18F-DOPA摄取显著增加，表明壳核中新生成的多巴胺能神经元信号强度显著增强。

This provides direct imaging evidence that the transplanted cells can effectively survive, engraft, differentiate, and function in the patients' brain..

这提供了直接的影像学证据，证明移植的细胞可以有效地在患者大脑中存活、植入、分化并发挥功能。

-  In terms of safety, no adverse events related to transplanted stem cells have occurred in any of the transplanted patients.

在安全性方面，任何移植患者都没有发生与移植干细胞相关的不良事件。

The encouraging results from the Phase I clinical trial paved the way for the initiation of Phase II clinical trial, approved by China's National Medical Products Administration (NMPA) and hospital ethics committees.

一期临床试验的鼓舞人心的结果为启动二期临床试验铺平了道路，并获得了中国国家药品监督管理局（NMPA）和医院伦理委员会的批准。

Delving into the Mechanism of XS411

深入研究XS411的机制

iPSC-derived cell therapy refers to a type of regenerative medicine that uses cells produced from induced pluripotent stem cells (iPSCs) to repair, replace, or restore damaged cells and tissues in the body.

诱导多能干细胞（iPSC）衍生的细胞疗法是一种再生医学，它利用由诱导多能干细胞生成的细胞来修复、替代或恢复体内受损的细胞和组织。

This is precisely the technological foundation underlying XellSmart's XS411 cell therapy. An allogeneic, off–the–shelf, iPSC–derived, dopaminergic neural progenitor cell product, XS411 received clearances in 2025 from both China NMPA and the US FDA to launch registrational clinical trials.

这正是 XellSmart 的 XS411 细胞疗法所基于的技术基础。XS411 是一种同种异体、现成的、iPSC 衍生的多巴胺能神经祖细胞产品，于 2025 年获得中国国家药品监督管理局 (NMPA) 和美国食品药品监督管理局 (FDA) 的批准，启动注册性临床试验。

Professor Feng Tao explained:'The central pathological feature of Parkinson's disease is the progressive degeneration and loss of dopaminergic neurons in the substantia nigra of the brain, resulting in a profound dopamine deficit that leads to tremor, rigidity, bradykinesia, and other motor symptoms.'.

冯涛教授解释说：“帕金森病的核心病理特征是大脑黑质区域多巴胺能神经元的进行性退化和丧失，导致严重的多巴胺缺乏，从而引发震颤、僵硬、运动迟缓等运动症状。”

'Once dopaminergic neurons are damaged, we replace them with new, healthy cells. This core principle of cell replacement therapy explains the fundamental distinction between stem cell-based therapy and conventional drugs or surgical interventions (such as levodopa-based medications, deep brain stimulation, magnetic resonance-guided focused ultrasound): rather than merely managing symptoms, it repairs impaired neural circuits by replacing degenerating cells with functional, healthy dopaminergic neurons.'.

“一旦多巴胺能神经元受损，我们就会用新的健康细胞来替代它们。这种细胞替代疗法的核心原则解释了基于干细胞的疗法与传统药物或外科干预（如基于左旋多巴的药物、脑深部刺激、磁共振引导的聚焦超声）之间的根本区别：它不仅仅是缓解症状，而是通过用功能性、健康的多巴胺能神经元替换退化的细胞来修复受损的神经回路。”

This strategy is not entirely novel. As early as the late 20

这一策略并非完全新颖。早在20世纪晚期，

th

th

century, Swedish scientists attempted to transplant dopaminergic neurons derived from fetal brain tissue, with some successful outcomes reported. However, this approach ultimately proved unsustainable for two key reasons: significant ethical concerns, and the extremely limited cell source — treating a single patient required four to five fetal brains, which could never satisfy clinical demand..

世纪，瑞典科学家尝试移植来自胎儿脑组织的多巴胺能神经元，取得了一些成功的成果。然而，这种方法最终被证明是不可持续的，主要原因有两个：显著的伦理争议，以及细胞来源极为有限——治疗一位患者需要四到五个胎儿大脑，这根本无法满足临床需求。

iPSC technology has perfectly addressed this ethical issue. This Nobel Prize-winning innovation enables the reprogramming of healthy human somatic cells back to a pluripotent state, which can then be directed to differentiate into physiologically functional target cells such as dopaminergic neural progenitor cells. .

iPSC技术完美地解决了这个伦理问题。这项获得诺贝尔奖的创新技术能够将健康的体细胞重新编程为多能状态，然后可以引导它们分化为生理功能性的目标细胞，例如多巴胺能神经祖细胞。

Professor Feng Tao stated:'Induced pluripotent stem cell therapy specifically involves reprogramming healthy somatic cells into pluripotent stem cells in vitro by introducing specific transcription factors, and then inducing their differentiation into dopaminergic neural precursor cells. These cells are then transplanted into the putamen region of Parkinson's patients through minimally invasive surgery'. .

冯涛教授介绍：“诱导型多能干细胞治疗，是通过特定转录因子将健康的体细胞在体外重编程为多能干细胞，再诱导其向多巴胺能神经前体细胞分化，通过微创手术将其移植到帕金森病患者的壳核部位。”

After transplantation, the cells can survive long-term and differentiate into dopaminergic neurons, synthesize and secrete dopamine, and repair damaged neural circuits, thereby replacing the degenerated and dead dopaminergic neurons.

移植后，细胞可以长期存活并分化为多巴胺能神经元，合成和分泌多巴胺，修复受损的神经回路，从而替代退化和死亡的多巴胺能神经元。

A Patient's Journey

患者的旅程

In the corridor of the Movement Disorder Department at Beijing Tiantan Hospital, a letter of gratitude from a Phase I patient stood out.

在北京天坛医院运动障碍科的走廊里，一封来自一期患者的感谢信格外显眼。

'I am a Parkinson's disease patient from northeastern China. As time went by, my condition kept deteriorating. I noticed the team led by Director Feng Tao from the Movement Disorder Disease Department of Tiantan Hospital began to conduct academic research experiments on stem cell transplantation for the treatment of Parkinson's disease — this rekindled the dying flame of my life and awakened my desire for survival'..

“我是一名来自中国东北的帕金森病患者，随着时间推移，我的病情不断恶化。我注意到天坛医院运动障碍疾病科冯涛主任带领的团队开始进行干细胞移植治疗帕金森病的学术研究试验——这重新点燃了我生命的希望之火，唤醒了我求生的欲望。”

The writer Mr. Zhang is a mid-to-late-stage Parkinson's disease patient, whose quality of life has undergone a qualitative leap after receiving the Phase I therapy. Formerly, he has been suffering from the condition for more than ten years, troubled by multiple motor and non-motor symptoms. Initially, medication was effective in controlling his condition, but as the disease progressed, the efficacy of the medication became increasingly poor, while the side effects became more pronounced..

作家张先生是一名中晚期帕金森病患者，在接受了一期治疗后，生活质量有了质的飞跃。此前，他已经患病十多年，深受多种运动症状和非运动症状的困扰。早期，药物对控制病情有效，但随着疾病进展，药效越来越差，副作用却愈发明显。

Though depressed, Mr. Zhang never gave up. He learned about an international breakthrough in Parkinson's disease treatment — stem cell therapy — and that Tiantan Hospital was conducting a 'registrational clinical trial of human allogeneic iPSC-derived dopaminergic neural progenitor cell injection (XS411) for the treatment of primary Parkinson's disease'.

虽然沮丧，但张先生从未放弃。他了解到帕金森病治疗的一项国际突破——干细胞疗法，并且天坛医院正在进行一项“人源异体iPSC衍生的多巴胺神经前体细胞注射（XS411）治疗原发性帕金森病的注册临床试验”。

He signed up without hesitation..

他毫不犹豫地签了名。

Mr. Zhang told the doctors of the research team:'I truly believe scientific progress will bring hope — I trust the professional team at Tiantan Hospital wholeheartedly, and I am more than willing to contribute my part to medical advancement.'

张先生对研究团队的医生说：“我真心相信科学的进步会带来希望——我完全信任天坛医院的专业团队，也非常愿意为医学进步贡献自己的力量。”

After rigorous screening, Mr. Zhang met the criteria for enrollment. The surgical procedure caused significantly less damage than he had imagined, as Professor Feng Tao illustrated:

经过严格的筛查，张先生符合入组条件。手术过程的损伤比他想象的要小得多，正如冯涛教授介绍的：

'The entire process was minimally invasive. Most patients can wake up and walk on the same day. The incisions are small, and recovery is quick'.

“整个过程微创。大多数患者在同一天可以醒来并下地行走。切口小，恢复快。”

After the surgery, Mr. Zhang's physical condition improved significantly. Not only did his motor function see great improvement, but his mood, sleep disturbances, and daytime fatigue also were notably relieved. Mr. Zhang was overjoyed, as the outcomes exceeded his expectations.

手术后，张先生的身体状况显著改善，不仅运动功能得到极大恢复，情绪、睡眠障碍和日间疲劳也明显缓解。张先生喜出望外，因为效果超出了他的预期。

Professor Feng Tao further explained: 'Mr. Zhang's situation is not an isolated case — similar improvement trends were observed in all patients enrolled in our study. Some patients reported being able to cook for themselves now, while others noted they could finally easily go up and down stairs. Most notably, the daily duration of their good condition has increased significantly'..

冯涛教授进一步解释说：“张先生的情况并非个例——我们研究中所有患者都观察到了类似的改善趋势。一些患者报告说现在可以自己做饭了，另一些患者则表示终于能够轻松上下楼梯。最显著的是，他们状态良好的持续时间显著增加。”

Projection based on the Global Burden of Disease (GBD) database indicates that the number of Parkinson's disease patients in China may reach 10 million by 2050. From dopamine supplementation to stem cell replacement therapy, and from symptom management to neural repair, this profound transformation in Parkinson's disease treatment is positioning China at the forefront of iPSC-derived cell therapy development.

基于全球疾病负担（GBD）数据库的预测表明，到2050年，中国的帕金森病患者人数可能达到1000万。从多巴胺补充疗法到干细胞替代疗法，从症状管理到神经修复，帕金森病治疗领域的这一深刻变革正使中国走在iPSC衍生细胞疗法开发的前沿。

With the commencement of Phase II clinical trial of XS411, XellSmart, the sponsor, along with Professor Feng Tao and his team, are leading this transformation with their professionalism, compassion and sense of urgency to bring new hope to countless individuals like Mr. Zhang..

随着XS411二期临床试验的启动，赞助方XellSmart公司以及冯涛教授及其团队，正以他们的专业精神、同情心和紧迫感引领着这一变革，为无数像张先生这样的个体带来新的希望。

CONTACT:

联系人：

[email protected]

电子邮件地址

SOURCE XellSmart Biopharmaceutical (Suzhou/Shanghai) Co., Ltd.

源熙智生物医药科技（苏州/上海）有限公司

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