主要目的：评价hAESCs注射液治疗造血干细胞移植后难治性aGVHD受试者的安全性和耐受性。次要目的：1、初步评价hAESCs注射液治疗造血干细胞移植后难治性aGVHD受试者的疗效； 2、初步评价hAESCs注射液治疗造血干细胞移植后难治性aGVHD受试者的药代动力学（PK）特征； 3、初步评价hAESCs注射液治疗造血干细胞移植后难治性aGVHD受试者的免疫原性。

开始日期2024-02-19

申办/合作机构

上海赛傲生物技术有限公司

NCT06164288 / Not yet recruiting临床1期

A Phase I Study to Evaluate the Safety and Efficacy of Human Amniotic Epithelial Stem Cell（hAESCs）Injection Treatment for the Patients With Refractory aGVHD After Allogeneic Hematopoietic Cell Transplantation (HCT)

Allogeneic hematopoietic stem cell transplantation (allo-HSCT), a process in which hematopoietic stem cells from a donor are injected into the recipient's body, are the treatment of choice for many hematologic malignancies. Graft-versus-host disease (GVHD) is a common and important complication after allogeneic HSCT. GVHD is a major obstacle to the success of HSCT treatment and a leading cause of death after HSCT treatment.
Hormone therapy is currently the standard treatment for aGVHD, i.e., the first-line treatment. However, 40%
50% of aGVHD cannot be controlled by hormone therapy, and additional therapeutic intervention is required. According to the National Comprehensive Cancer Network (NCCN) clinical practice guidelines for hematopoietic stem cell transplantation - pre-transplant recipient evaluation and management of GVHD (2021.V3), the recommended drugs for second-line treatment of grade II
IV aGVHD include: alemtuzumab, α-1 antitrypsin, antithymocyte globulin, basiliximab, calcineurin inhibitors, etanercept, extracorporeal photopheresis replacement therapy, infliximab, mammalian rapamycin target protein inhibitors, mycophenolate mofetil, Pentostatin, ruxolitinib, tocilizumab. Second-line treatment is based on retrospective data and there is no standard salvage therapy, which is reflected in the inconsistent treatment strategy for aGVHD across transplant centers.
One of the biological functions of hAESCs in amniotic membranes in vivo is to exert reproductive immunomodulatory effects and protect the fetus from rejection by the maternal immune system, so hAESCs have natural immunomodulatory functions. hAESCs have significant inhibitory effects on T cells, antigen-presenting cells (APCs), natural killer (NK) cells, macrophages, neutrophils, B cells and other immune cells associated with organ damage during the pathogenesis of aGVHD, and hAESCs have great potential in the treatment of aGVHD. Therefore, the sponsor developed hAESCs injections intended for the treatment of aGVHD.
The experimental drug in this study is hAESCs injection, which is intended to be used for the treatment of adult patients with grade III.
IV. refractory aGVHD after hematopoietic stem cell transplantation, and to explore the safety and preliminary efficacy of its treatment.

开始日期2024-01-01

申办/合作机构

上海赛傲生物技术有限公司

100 项与人羊膜上皮干细胞(Shanghai iCELL Biotechnology) 相关的临床结果

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100 项与人羊膜上皮干细胞(Shanghai iCELL Biotechnology) 相关的专利（医药）

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项与人羊膜上皮干细胞(Shanghai iCELL Biotechnology) 相关的文献（医药）

2024-10-14·BIOLOGY OF REPRODUCTION

Human amniotic epithelial cells improve uterine spiral artery remodeling to ameliorate preeclampsia in a rat model

Article

作者: Zhong, Xiaocui ; Han, Ting-Li ; Zhou, Yanqiu ; Dong, Xiaojing ; Zhang, Guanghui ; Geng, Lanxin ; Qin, Zuchao

Abstract:

Preeclampsia (PE) is a multisystem pregnancy disorder characterized by impaired remodeling of placental spiral arteries, which leads to the release of pro-inflammatory cytokines and anti-angiogenic agents. However, treatment options for PE are limited, with termination of pregnancy being the only curative option. In this work, we investigated the effects of human amniotic epithelial cells (hAECs) in PE rat model. The rats were induced with lipopolysaccharide (LPS) on gestational day 14.5 followed by injection of hAECs and human umbilical cord mesenchymal stem cells 24 h later. The hAECs treatment resulted in a reduction in blood pressure and proteinuria in the PE rat model. Furthermore, hAECs treatment decreased levels of pro-inflammatory cytokines, reduced inflammatory cells aggregation, and alleviated the damage to placental spiral arteries by downregulating the expression of anti-angiogenic factor and upregulating proangiogenic factor. In vitro experiments confirmed that hAECs treatment restored the proliferation, migration, and angiogenesis of LPS-damaged human umbilical vein endothelial cells. Additionally, hAECs treatment had positive effects on fetal weight and neurological development in the PE group, with no negative effects on the physical development or fertility of offspring rats. These results suggested that hAECs transplantation may be a novel adjuvant therapeutic strategy for PE by reducing the inflammatory and enhancing placental spiral artery angiogenesis.

2023-11-01·Advanced science (Weinheim, Baden-Wurttemberg, Germany)

A 3D‐Printed Dual Driving Forces Scaffold with Self‐Promoted Cell Absorption for Spinal Cord Injury Repair

Article

作者: Li, Jinying ; Liu, Jia ; He, Zhiying ; Kou, Yaohui ; Wang, Guanghao ; Yu, Kang ; Sun, Yuan ; Qiu, Cong ; Zhang, Shaomin ; Yuan, Weixin ; Yu, Luyang ; Jiang, Yuanqing ; Qiu, Chen ; Liu, He ; Xu, Yuchen ; Jiang, Tuoying ; Zhou, Jiayi ; Ge, Zhen ; He, Yong ; Cui, Wenyu

Abstract:

Stem cells play critical roles in cell therapies and tissue engineering for nerve repair. However, achieving effective delivery of high cell density remains a challenge. Here, a novel cell delivery platform termed the hyper expansion scaffold (HES) is developed to enable high cell loading. HES facilitated self‐promoted and efficient cell absorption via a dual driving force model. In vitro tests revealed that the HES rapidly expanded 80‐fold in size upon absorbing 2.6 million human amniotic epithelial stem cells (hAESCs) within 2 min, representing over a 400% increase in loading capacity versus controls. This enhanced uptake benefited from macroscopic swelling forces as well as microscale capillary action. In spinal cord injury (SCI) rats, HES–hAESCs promoted functional recovery and axonal projection by reducing neuroinflammation and improving the neurotrophic microenvironment surrounding the lesions. In summary, the dual driving forces model provides a new rationale for engineering hydrogel scaffolds to facilitate self‐promoted cell absorption. The HES platform demonstrates great potential as a powerful and efficient vehicle for delivering high densities of hAESCs to promote clinical treatment and repair of SCI.

2023-01-01·Frontiers in neuroscience

Protection against brain injury after ischemic stroke by intravenous human amnion epithelial cells in combination with tissue plasminogen activator.

Article

作者: Kim, Hyun Ah ; Sobey, Christopher G ; Lim, Rebecca ; Chan, Siow Teng ; Ma, Henry ; Zhang, Shenpeng R ; Phan, Thanh G ; Drummond, Grant R ; Barreto-Arce, Liz J

Background:

Thrombolytic agents such as tissue plasminogen activator (tPA) are the only drug class approved to treat ischemic stroke and are usually administered within 4.5 h. However, only ~20% of ischemic stroke patients are eligible to receive the therapy. We previously demonstrated that early intravenous administration of human amnion epithelial cells (hAECs) can limit brain inflammation and infarct growth in experimental stroke. Here, we have tested whether hAECs exert cerebroprotective effects in combination with tPA in mice.

Methods:

Male C57Bl/6 mice were subjected to middle cerebral artery occlusion for 60 min followed by reperfusion. Immediately following reperfusion, vehicle (saline, n = 31) or tPA (10 mg/kg; n = 73) was administered intravenously. After 30 min of reperfusion, tPA-treated mice were injected intravenously with either hAECs (1×10⁶; n = 32) or vehicle (2% human serum albumin; n = 41). A further 15 sham-operated mice were treated with vehicle (n = 7) or tPA + vehicle (n = 8). Mice were designated to be euthanised at 3, 6 or 24 h post-stroke (n = 21, 31, and 52, respectively), and brains were collected to assess infarct volume, blood-brain barrier (BBB) disruption, intracerebral bleeding and inflammatory cell content.

Results:

There was no mortality within 6 h of stroke onset, but a high mortality occurred in tPA + saline-treated mice between 6 h and 24 h post-stroke in comparison to mice treated with tPA + hAECs (61% vs. 27%, p = 0.04). No mortality occurred within 24 h of sham surgery in mice treated with tPA + vehicle. We focused on early infarct expansion within 6 h of stroke and found that infarction was ~50% larger in tPA + saline- than in vehicle-treated mice (23 ± 3 mm³ vs. 15 ± 2 mm³, p = 0.02) but not in mice receiving tPA + hAECs (13 ± 2 mm³, p < 0.01 vs. tPA + saline) in which intracerebral hAECs were detected. Similar to the profiles of infarct expansion, BBB disruption and intracerebral bleeding in tPA + saline-treated mice at 6 h was 50-60% greater than in vehicle-treated controls (2.6 ± 0.5 vs. 1.6 ± 0.2, p = 0.05) but not after tPA + hAECs treatment (1.7 ± 0.2, p = 0.10 vs. tPA + saline). No differences in inflammatory cell content were detected between treatment groups.

Conclusion:

When administered following tPA in acute stroke, hAECs improve safety and attenuate infarct growth in association with less BBB disruption and lower 24 h mortality.

100 项与人羊膜上皮干细胞(Shanghai iCELL Biotechnology) 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
宫腔粘连	临床2期	中国	上海赛傲生物技术有限公司	2022-01-30
帕金森病	临床2期	中国	上海赛傲生物技术有限公司	2022-01-30
原发性卵巢功能不全	临床2期	中国	上海赛傲生物技术有限公司	2022-01-30
难治性急性移植物抗宿主病	临床2期	中国	上海赛傲生物技术有限公司	2022-01-30
急性移植物抗宿主病	临床1期	-	上海赛傲生物技术有限公司	2024-01-01
移植物抗宿主病	临床1期	中国	北京大学人民医院	2020-06-26
急性肾损伤	临床前	中国	上海赛傲生物技术有限公司	2022-01-30
自闭症	临床前	中国	上海赛傲生物技术有限公司	2022-01-30
桥本病	临床前	中国	上海赛傲生物技术有限公司	2022-01-30
脊髓损伤	临床前	中国	上海赛傲生物技术有限公司	2022-01-30