This protocol is part of a clinical study to evaluate efficacy and safety of multiple intravenous administrations of HB-adMSCs for the treatment of Multiple Sclerosis.

开始日期2025-05-02

申办/合作机构

Hope Biosciences Research Foundation

NCT05951777

/ Recruiting临床2期

Autologous Adipose-Derived Mesenchymal Stem Cells for Chronic Traumatic Brain Injury

The global objective of this study is to establish the safety and investigate the potential treatment effect of an intravenous infusion of HB-adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells) on brain structure, neurocognitive/functional outcomes, and neuroinflammation after traumatic brain injury.

开始日期2024-04-16

申办/合作机构

Hope Biosciences LLC

NCT05116540

/ Completed临床2期

A Randomized, Double-Blind, Single-Center, Phase 2, Efficacy and Safety Study of Autologous HB-adMSCs vs Placebo for the Treatment of Patients With Multiple Sclerosis

Randomized Double-Blind Efficacy and safety study of Autologous HB-adMSCs versus placebo for the treatment of Multiple Sclerosis. This study will be for 24 subjects with 6 infusions over a 52 week period. Study participants will continue their established concomitant medications during participation in this investigation.

开始日期2021-11-24

申办/合作机构

Hope Biosciences Research Foundation

100 项与 Autologous adipose derived mesenchymal stem cells (Hope Biosciences) 相关的临床结果

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100 项与 Autologous adipose derived mesenchymal stem cells (Hope Biosciences) 相关的转化医学

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100 项与 Autologous adipose derived mesenchymal stem cells (Hope Biosciences) 相关的专利（医药）

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项与 Autologous adipose derived mesenchymal stem cells (Hope Biosciences) 相关的文献（医药）

2022-01-01·Journal of translational autoimmunity

Frequency-dependent effect of intravenous administration of human adipose-derived mesenchymal stem cell therapy for severe Systemic Lupus Erythematosus: A case report

作者: Tripathy, Mallika ; Chang, Donna ; Vij, Ridhima ; Lotfi, Djamchid ; Park, Hyeonggeun ; Cheng, Thanh ; Kim, Hosu

Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease that involves abnormal activation of immune response, affecting multiple organs, including joints, kidneys, lungs, skin, and the hematopoietic system, thereby impairing their normal function. Despite there being no cure for SLE, Mesenchymal Stem Cell (MSC) therapy offers hope for SLE patients because of its potent role in immunomodulation. Here, we report a case of a 65-year-old female battling with SLE for almost 30 years and on a treatment regimen consisting of several medications. Given the level of immunosuppression associated with conventional SLE treatments, the subject was initially enrolled as a participant in a study protocol designed to provide immune protection against COVID-19. The subject received multiple infusions of autologous Hope Biosciences adipose-derived MSCs (HB-adMSCs) which significantly improved her SLE symptoms and functionality that led the patient's physician to discontinue her Rituximab regime. Based on her response to HB-adMSC therapy, the subject was approved to receive a set of nine infusion treatments to specifically treat her SLE symptoms. Over the course of ∼ one year, the first six infusions were given on a monthly basis, while the remaining three were administered bimonthly - each with a dose of 200 million HB-adMSCs. Since the beginning of the treatment, the subject showed remarkable improvements in her SLE symptoms, as demonstrated by changes in her SF-36 questionnaire responses, Visual Analog Scale (VAS) scores, and C-Reactive Protein (CRP) measurements; however, worsening of the symptoms was noted later during treatment course (when the frequency of infusions changed to bimonthly). Although the shift in remission-relapse cycle is not fully understood, however, the data suggest that treatment frequency might be the key player. No serious adverse events occurred during the entire treatment period. Further research is needed to evaluate the results of this study.

Frontiers in neurology

Long-term, repeated doses of intravenous autologous mesenchymal stem cells for a patient with Parkinson's disease: a case report

作者: Tripathy, Mallika ; Chang, Donna ; Lotfi, Djamchid ; Vij, Ridhima ; Kim, Hosu ; Prossin, Alan ; Cheng, Thanh ; Park, Hyeonggeun

Parkinson's disease (PD) is a neurodegenerative disease that involves the loss of dopaminergic neurons in the substantia nigra pars compacta of the basal ganglia. Clinically, patient presentation involves a combination of motor and non-motor symptoms characterized by progressive worsening over time and significant decreases in overall quality-of-life. Despite there being no fully restorative cure for PD, Mesenchymal Stem Cell (MSC) therapy offers promising therapeutic potential. Here, we report a case of a 77-year-old female, living with idiopathic Parkinson's Disease for over 17 years. The patient received multiple infusions of autologous Hope Biosciences adipose-derived MSCs (HB-adMSCs). A total of 26 infusion treatments of HB-adMSCs were administered over the course of ~2 years that resulted in marked improvements in her typical Parkinsonian symptoms, as demonstrated by the decreases in her UPDRS (Unified Parkinson's Disease Rating Scale) scores. Changes in clinical scores mirrored concurrent changes in regional brain metabolism as quantified by FDG-PET (Fluorodeoxyglucose-Positron Emission Tomography), compared to baseline. Long-term, multiple infusions of HB-adMSCs were safely tolerated by the patient without any serious adverse events. Further research is needed to evaluate the safety and efficacy of HB-adMSC therapy for the treatment of PD patients.

BRAIN

Autologous adipose-derived mesenchymal stromal cells for chronic traumatic brain injury

Article

作者: Pedroza, Claudia ; Collier, Aidan ; Duron, Maria Carmen ; Scott, Michael C ; Kosmach, Steven ; Juranek, Jenifer ; Olson, Scott D ; Prossin, Alan R ; Savitz, Sean I ; Schriner, Jacob B ; Chen, Bingrui ; Cox, Charles S ; Ashley, Janet R ; Ewing-Cobbs, Linda ; Bianchi, Joana

Abstract:

Secondary injury from traumatic brain injury (TBI) leads to a chronic inflammatory process, neurodegeneration, and tissue loss, resulting in poor outcomes. Mesenchymal stromal cell (MSC) treatment can dampen microglial activation and improve TBI outcomes. Our study aimed to assess the impact of autologous adipose-derived MSC treatment in adult patients with chronic TBI using imaging, functional, and neurocognitive outcome measures.Our Phase 1/2a study analyzed safety and treatment effect of 3 intravenous infusions (over 6 weeks) of autologous adipose-derived MSCs (HB-adMSCs) in 24 chronic TBI patients. Outcome measures included functional, neuropsychological, and psychometric testing; multimodal MRI; and PET using [11C]ER176 to measure brain immune cell density. There were no serious treatment-related adverse events. DT-MRI analyses in a priori regions of interest showed that at 6 months after treatment, elevated mean diffusivity volumes (supraMD) were significantly reduced bilaterally in the hippocampus (mean decrease 163.51 mm3, 95% CI -286.55 to -41.51 mm3; P=0.013). A trend for reduced supraMD was observed in the amygdala (mean decrease 113.60 mm3, 95% CI -229.52 to 2.90 mm3; P=0.058); no changes in the insula were observed (P=0.19). Brain-behavior analyses indicated significant interactions between levels in baseline neuropsychological assessments of anxiety and depression and magnitude of supraMD changes in the amygdala and hippocampus, respectively. Macrostructural volumetric changes were not significant in the hippocampus, amygdala, or insula (all P >0.10).PET results showed that HB-adMSC treatment induced significant reductions in brain immune cell density in the right caudate (x,y,z: 12,2,7; T20 = 4.1; P <0.0003), extending into both the right ventral anterior thalamus (x,y,z: 13, -2,11; T20 = 3.6; P < 0.0009) and right nucleus accumbens (x,y,z: 8,9, -3; T20 = 2.5; P < 0.01), and right parahippocampal gyrus (x,y,z: 29, -40, -7; T20 = 3.1; P <0.003). Reductions in measures of depression (P=0.026), fatigue (P=0.008), and pain (P=0.007) 6 months after treatment were also observed.Our study demonstrates autologous adipose-derived MSCs for chronic TBI are safe, have clinically relevant treatment effect sizes in functional and neurocognitive outcome measures, yield significant improvements in specified measures of microstructural integrity (i.e., reduced volume of elevated MD voxels) in brain-based behavior relations, and reduce density of brain immune cells in regions corresponding to pain, fatigue, and depression. These data provide quantitative justification for the sample size of next-phase clinical trials using either functional outcomes or surrogate imaging outcomes.

项与 Autologous adipose derived mesenchymal stem cells (Hope Biosciences) 相关的新闻（医药）

2026-04-01

·九州再青春生物科技

2026 年 3 月干细胞领域里程碑：日本 iPSC 疗法商业化破冰，中国主导国际标准制定

2026 年，全球干细胞治疗产业迎来关键转折，正式从长期研究积累阶段迈入临床应用爆发期。历经 20 年技术沉淀，诱导多能干细胞（iPSC）疗法率先在日本实现商业化落地；与此同时，中国在行业规则制定层面实现突破，主导发布核心国际标准，彰显全球影响力。一、日本率先获批两款 iPSC 疗法，开启商业化新纪元 2026 年 2 月 19 日，日本厚生劳动省专家委员会通过附条件批准程序，正式放行两款基于 iPSC 技术的细胞治疗产品上市[1]，这是 iPSC 技术自 2006 年问世以来，首次以商业化药品形式走向临床应用。Amchepry ——针对帕金森病，通过植入 iPSC 分化的多巴胺能神经前体细胞，修复大脑多巴胺分泌通路。ReHeart ——用于重度心力衰竭治疗，以 iPSC 来源心肌细胞制成的细胞贴片，贴附于心脏受损区域，促进心肌修复与功能重建。该里程碑式进展引发全球关注，但《Nature》杂志也援引学界观点指出，部分研究者（如加州大学戴维斯分校 Paul Knoepfler）对此次快速审批持谨慎态度，认为现有临床试验数据的充分性仍需进一步验证。二、中国主导发布干细胞数据国际标准，构建规则话语权 2026 年 3 月 3 日，由中国牵头制定的《干细胞数据的核心特征》国际标准正式发布，填补了该领域国际标准空白，标志着中国在干细胞与再生医学领域的研发实力与行业影响力获得国际认可。 "能够写成国际标准，表明了我国在干细胞和再生医学领域的原创研发和临床试验居于国际前沿。"[2] 截至目前，中国已累计牵头发布 4 项干细胞领域国际标准，初步构建起覆盖基础研究、数据管理、专项应用及安全检测的全链条标准体系[2]。三、欧洲加码布局，1.5 亿欧元注入干细胞再生医学研发 2026 年 3 月，荷兰莱顿大学医学中心（LUMC）作为 reNEW 联盟核心成员，获得诺和诺德基金会 1.5 亿欧元专项资助，项目周期延续至 2031 年[6]。这笔资金将重点用于开发针对慢性病的干细胞创新疗法，同时巩固 LUMC 在全球干细胞研究领域的核心地位[6]。reNEW 联盟此前已完成第一阶段研发，本次拨款[6]为第二阶段持续投入，彰显欧洲对干细胞再生医学领域的长期战略布局。四、帕金森病干细胞疗法临床突破，MSC 疗法 II 期数据亮眼在帕金森病治疗领域，Hope Biosciences 开发的脂肪来源间充质干细胞（HB-adMSC）疗法，在 II 期临床试验（NCT04995081）中取得积极结果。研究数据显示，与安慰剂组相比，接受 HB-adMSC 治疗的患者运动功能获得统计学显著改善，同时达到患者自评运动日常体验（MDS-UPDRS Part II）与临床医生评估运动功能双主要终点。基于积极数据，研发团队已启动 III 期验证性临床试验[5]筹备工作。五、中国监管体系完善，双法规护航细胞治疗产业提速 2026 年 5 月，中国将密集落地两项生物医药重磅法规，构建 “NMPA 管药 + 卫健委管术” 的双轨并行监管格局，为细胞治疗产业发展提供清晰合规路径。条例文号施行日期核心看点《生物医学新技术临床研究和临床转化应用管理条例》国务院令第818号2026年5月1日划定研究、转化、收费各阶段规则《中华人民共和国药品管理法实施条例》国务院令第828号2026年5月15日细胞治疗进入"合规+创新"黄金期两项法规分别由国家卫健委和国家药监局主导，标志着中国生物医药产业"NMPA管药+卫健委管术"双轨并行格局正式形成。截至 2025 年 5 月，中国已有 148 家医疗机构完成国家级干细胞临床研究备案，133 项临床研究项目获批，覆盖 31 个省级行政区、50 余种疾病[3]，2026 年被业内视为中国细胞治疗产业 “全面提速年”[4]。六、全球干细胞赛道竞争格局：商业化与研发双线推进方向代表进展阶段信源 iPSC帕金森日本Amchepry附条件批准 ✅ 商业化 Nature iPSC心衰日本ReHeart附条件批准 ✅ 商业化 Nature MSC帕金森 HB-adMSC II期达主要终点，III期在即 🔄 III期临床试验注册 iPSC胰岛（1型糖尿病） Vertex VX-880进入3期，关键阶段 🔄 申报在即 Vertex公告+ATTD 2026 中国干细胞数据标准中国牵头制定，国际标准正式发布 ✅ 已发布 CCTV 欧洲干细胞研发 reNEW联盟1.5亿欧元资助至2031年 🔄 资助中莱顿大学官方中国监管双规落地 818号令+828号令5月正式施行 ⏳ 即将施行国务院令官方公告中国148家医院+133项目覆盖31省，50+疾病 🔄 临床进行中国家医学研究登记备案系统 CAR-T联合干细胞（AML） NOT门控设计保护正常造血干细胞 🧪 临床前 AACR摘要 GVHD双药预防 ATG/PTCy联用降低移植后GVHD风险 🔄 临床成熟 AACR摘要结语 2026 年，iPSC 技术在日本率先实现商业化突破，中国凭借国际标准制定占据行业规则高地，欧洲以重金持续投入巩固研发优势。如何在监管审慎与商业化速度间寻求平衡，将成为未来几年全球干细胞领域的核心命题。 2026 年 7 月，ISSCR 年度大会将在加拿大蒙特利尔召开，预计 3500 余名科学家齐聚，发布更多干细胞领域前沿成果，值得持续关注。编辑留存 · 参考来源 [1] Asher Mullard, "First-of-a-kind stem-cell therapies set for approval in Japan", Nature, 2026-02-23.https://www.nature.com/articles/d41586-026-00585-x [2] 央视网, "我国牵头的干细胞数据核心特征国际标准发布", 2026-03-03.https://news.cctv.com/2026/03/03/ARTI0OphiXJxXjOAip1yKFoY260303.shtml [3] 医药魔方ByDrug等, "2025年干细胞最新进展：133项获批临床，148家医院同步开展!", 2025.https://www.163.com/dy/article/K4O9Q1P50556C745.html [4] 新浪财经, "2026年，中国细胞疗法全面提速", 2026-01-04.https://finance.sina.cn/2026-01-04/detail-inhfcphp0312154.d.html [5] Clinical Trials Arena, "Parkinson's stem cell therapy demonstrates promise in Phase II trial", 2026.https://www.clinicaltrialsarena.com/news/hope-biosciences-research-foundation-stem-cell-parkinsons-phase-ii/ [6] Leiden University, "LUMC receives tens of millions for research into new stem cell-based treatments", 2026-03-02.https://www.universiteitleiden.nl/en/news/2026/03/lumc-receives-tens-of-millions-for-research-into-new-stem-cell-based-treatments 免责声明本公众号发布文章初衷是为大众科普健康知识，传递行业前沿进展，不作为官方立场，不构成任何价值判断，不作为相关医疗指导，无任何商业用途，仅供读者参考。账号部分内容转载自其他媒体，目的在于传播健康讯息以供更多人交流学习，不对转载内容的准确性与完整性做任何承诺。

2024-10-31

·PipelineReview

Hope Biosciences Research Foundation Reports Promising Phase II Trial Results for Stem Cell Therapy in Multiple Sclerosis

SUGAR LAND, TX, USA I October 31, 2024 I Houston-area clinical research organization Hope Biosciences Research Foundation (HBRF) today shares positive top-line results of a Phase II clinical trial to evaluate Hope Biosciences’ adipose‑derived autologous mesenchymal stem cell therapy (HB-adMSCs) for patients with mild to moderate relapsing remitting multiple sclerosis (MS), a disease currently considered incurable that affects more than 2 million people worldwide and approximately 400,000 in the U.S. The trial successfully met its primary endpoint, demonstrating statistically significant improvements in both physical and mental health for the treatment group compared to the placebo group. The Phase II clinical trial (NCT05116540) is a balanced randomized, double-blind, single center study that enrolled 24 participants, 12 in the treatment group and 12 in the placebo. The study mandated six intravenous infusions of 200 million stem cells over the course of 32 weeks, for a total of 1.2 billion cells. End of study was 52 weeks. The primary endpoint was the MS Quality of Life-54 Instrument, a multidimensional quality of life measure that combines general and MS-specific points related to fatigue, physical and cognitive function, sexual impairment, pain, energy, mobility, level of disability, and other considerations. At end of study, the HB-adMSC group showed a statistically significant improvement from baseline in their Physical Health Composite Scores (p<0.0001) compared to the placebo group (p<0.4856). The effect size between the groups was large (Cohen’s d=1.23), with a significant overall treatment difference (p=0.0002). The HB-adMSC group also exhibited a significant improvement from baseline in their Mental Health Composite Scores (p<0.0042) compared to the placebo group (p<0.5724). The effect size was substantial (Cohen’s d=0.85), with a statistically significant overall treatment difference (p=0.016). Treatment was safe and tolerable in both groups. Detailed analysis is now underway. “The results of this trial are groundbreaking for multiple sclerosis. They clearly demonstrate that high doses of fresh HB-adMSCs delivered on a regular schedule can result in consistent efficacy in a highly complex and variable condition like MS,” says Donna Chang, President, HBRF. “We believe that this positive response will translate in other autoimmune diseases in the near future.” This research was made possible in part by the generous support of The Robert and Janice McNair Foundation . Texas-based HBRF is a 501(c)(3) nonprofit organization administered by the Greater Houston Community Foundation. SOURCE: Hope Biosciences Research Foundation

临床结果临床2期细胞疗法

100 项与 Autologous adipose derived mesenchymal stem cells (Hope Biosciences) 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
创伤性脑损伤	临床2期	美国	Hope Biosciences LLC	2024-04-16
慢性脑部损伤	临床2期	美国	Hope Biosciences LLC	2024-04-16
复发-缓解型多发性硬化	临床2期	美国	Hope Biosciences Research Foundation	2021-11-24
帕金森病	临床2期	美国	Hope Biosciences Research Foundation	2021-06-28
阿尔茨海默症	临床2期	美国	Hope Biosciences LLC	2020-03-01
缺氧缺血性脑病	临床2期	美国	Hope Biosciences LLC	2020-01-01
类风湿关节炎	临床2期	美国	Hope Biosciences LLC	2018-09-25

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04063215 (CTgov)	临床1/2期	创伤性脑损伤 \| 缺氧缺血性脑病	24	HB-adMSCs	窪簾廠憲鏇顧糧構醖鏇(壓醖齋範糧積繭淵蓋淵) = 簾壓獵製蓋獵壓觸築鑰簾網憲築選衊鹹鑰網鹹 (廠遞選範糧鏇鹽窪築廠, 1.22) 更多	-	2026-01-15
NCT05116540 (HBMS01, CTgov)	临床2期	多发性硬化症 \| 复发-缓解型多发性硬化	24	HB-adMSCs (Treatment)	憲顧範簾壓築衊繭選網(糧蓋艱積遞簾膚鬱構繭) = 選繭鬱網範簾築艱醖憲願淵顧廠顧繭襯廠築顧 (蓋鏇鏇膚鏇觸觸築糧築, 9.61) 更多	-	2025-05-07
NCT05116540 (HBMS01, CTgov)	临床2期	多发性硬化症 \| 复发-缓解型多发性硬化	24	Placebo (Placebo)	憲顧範簾壓築衊繭選網(糧蓋艱積遞簾膚鬱構繭) = 鹽選顧簾鏇餘製襯蓋醖願淵顧廠顧繭襯廠築顧 (蓋鏇鏇膚鏇觸觸築糧築, 10.95) 更多	-	2025-05-07
NCT04928287 (PD, CTgov)	临床2期	帕金森病	24	Placebo+HB-adMSCs (HB-adMSCs)	積鏇願鹽憲範願鑰蓋齋(壓繭鑰糧遞遞襯鑰鹽範) = 憲鹽憲夢鹽夢衊鏇餘繭醖襯範壓範簾築襯範鹹 (糧醖齋襯顧網餘簾淵窪, 6.99) 更多	-	2024-05-20
NCT04928287 (PD, CTgov)	临床2期	帕金森病	24	Placebo+HB-adMSCs (Placebo)	積鏇願鹽憲範願鑰蓋齋(壓繭鑰糧遞遞襯鑰鹽範) = 觸窪積構簾獵鑰憲範繭醖襯範壓範簾築襯範鹹 (糧醖齋襯顧網餘簾淵窪, 5.15) 更多	-	2024-05-20
NCT04349631 (CTgov)	临床2期	新型冠状病毒感染	51	HB-adMSCs	繭夢築繭鹽鑰製簾糧廠 = 積襯糧觸簾糧膚簾製範夢構製糧築衊願醖獵餘 (鏇憲蓋鏇艱觸遞憲鹽顧, 餘蓋製壓網艱觸夢窪觸 ~ 醖襯衊簾鹽網蓋觸襯憲) 更多	-	2023-10-31
NCT03691909 (HB-adMSCs, CTgov)	临床1/2期	类风湿关节炎	15	HB-adMSCs	網糧鏇製築齋網窪網鬱 = 憲遞願蓋構憲壓廠觸簾蓋製淵蓋選願齋夢窪齋 (簾醖顧繭醖遞膚製鹽蓋, 壓艱範鏇獵壓願夢憲艱 ~ 構廠糧顧積艱構鹹構艱) 更多	-	2022-03-22