运用脐带间充质干细胞成功治疗3例COVID-19危重患者

2020/7/28 10:59:42 本站原创 佚名 【字体:

廖联明       编译

 

RESTEM生物技术公司和南佛罗里达浸信会健康中心宣布,三名患有急性呼吸窘迫综合征(ARDS)COVID-19患者获得美国食品和药物管理局(FDA)紧急批准,成为首批成功接受脐带间充质干细胞治疗的患者。

浸信会健康中心医生Guenther Koehne(医学博士)和Javier Perez-Fernandez(医学博士)通过静脉注射RESTEM的脐带内膜来源的间充质干细胞(ULSC)给病人提供了新的治疗方法。

接受这种治疗的患者在输注的几天内,氧需求量从100%降低到50%以下,同时血液中各种关键炎症标志物的水平也显著降低。

 “相比接受其他实验性疗法患者,这些患者更快地改进了他们的肺的状况,”Koehne博士说。Koehne博士是迈阿密癌症研究所的副主任与血液和骨髓移植的首席负责人, 同时也是佛罗里达国际大学(FIU)的Herbert Wertheim学院 (HWCOM) 医学院转化医学系的教授和主席。HWCOM的专家负责大学、浸信会健康中心和RESTEM之间进行合作。

 “我们的初步结果表明,使用这些细胞进行治疗可能会打破当今对COVID-19治疗的格局,”迈阿密浸信会医院(Baptist Hospital of Miami)的肺科医生和危重治疗主任Perez-Fernandez博士说到。

RESTEM的细胞是通过专利工艺从脐带组织中培养出来的,可以减少炎症,从而促进组织再生和愈合。

代号“SUCCESS (系统性脐带细胞以消除综合症严重程度) 试验将挑选出可能从ULSC中获益最大的COVID-19 ARDS患者,并就这些细胞治愈这种可怕疾病的能力进行随机对照试验(使用安慰剂对照)证据。

RESTEM ULSC用于治疗自身免疫性疾病(多发性肌炎和皮肌炎)的临床试验也通过了FDA的批准。患者也将能够在迈阿密癌症研究所和位于南达科他州Sioux Falls的桑福德健康中心参与这项临床试验。

 

Learn more:

https://newsroom.baptisthealth.net/press-release/baptist-health-physicians-successfully-treat-first-three-covid-19-critically-ill-patients-with-restems-umbilical-cord-mesenchymal-stem-cells/

 

原语言: 

Umbilical Cord Mesenchymal Stem Cells Used to Successfully Treat 3 Critically Ill COVID-19 Patients

 

RESTEM, a biotechnology company, and Baptist Health South Florida, announced that three COVID-19 patients with acute respiratory distress syndrome (ARDS) are the first to successfully be treated in the U.S. with umbilical cord mesenchymal stem cells under an emergency approval from the Food and Drug Administration (FDA).

Baptist Health physicians Guenther Koehne, M.D., Ph.D., and Javier Pérez-Fernández, M.D., administered the new treatment to patients through intravenous infusions of RESTEM’s umbilical cord lining-derived stem cells (ULSC).

The patients who received this treatment showed reduction of their oxygen requirement from 100 percent to less than 50 percent within days of the infusion, accompanied by significant reduction in levels of various key circulating inflammatory markers.

“These patients have improved their lung status much more quickly than patients treated with other experimental therapies,” said Dr. Koehne, deputy director and chief of blood & marrow transplant at Miami Cancer Institute, who is also professor and chairperson of the Department of Translational Medicine at the Herbert Wertheim College of Medicine (HWCOM) at Florida International University (FIU). Specialists at HWCOM spearheaded this collaborative effort between academia, Baptist Health and RESTEM.

 Our preliminary results show that therapy with these cells could be a game-changer in COVID-19,” stated Dr. Perez-Fernandez, pulmonologist and director of critical care at Baptist Hospital of Miami.

RESTEM’s cells are grown from umbilical cord tissue by a proprietary process and reduce inflammation, thereby allowing tissue regeneration and healing to occur.

 SUCCESS (Systemic Umbilical Cord Cells to Erase Syndrome Severity) Trial will identify COVID-19 ARDS patients that may best benefit from ULSC and will develop randomized placebo-controlled evidence regarding the ability of these cells to heal patients with this terrible disease.

The RESTEM ULSC have also been cleared by the FDA for testing their healing properties in the autoimmune conditions of polymyositis and dermatomyositis.  Patients will also be able to participate in this clinical trial both at the Miami Cancer Institute and at Sanford Health in Sioux Falls, South Dakota.

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