Hope Biosciences Research Foundation, 16700 Creek Bend Dr., Sugar Land, TX, 77478, USA.
Hope Biosciences, Sugar Land, TX, 77478, USA.
Stem Cell Res Ther. 2023 Oct 5;14(1):287. doi: 10.1186/s13287-023-03522-1.
Evolving mutations of the novel coronavirus continue to fuel up the pandemic. The virus affects the human respiratory system along with other body systems, causing several sequelae in the survivors of the disease, presented as post-COVID-19 syndrome or long-COVID-19. This protocol utilized Hope Biosciences' autologous, adipose-derived mesenchymal stem cells (HB-adMSCs) to evaluate safety and efficacy of HB-adMSC therapy to improve signs and symptoms associated with post-COVID-19 syndrome.
Ten eligible subjects with post-COVID-19 syndrome were enrolled in the program for a duration of 40 weeks who received 5 intravenous infusions of 2 × 10 autologous HB-adMSCs each at week 0, 2, 6, 10 and 14 with a follow-up at week 18 and end of the study at week 40. Safety assessments included incidence of adverse and serious adverse events along with the laboratory measures of hematologic, hepatic, and renal function. Efficacy was examined by quality-of-life assessments, fatigue assessments, Visual analog scale (VAS) of symptoms and monitoring of respiration and oxygen saturation rates.
VAS scores and Fatigue Assessment scores (FAS) showed significant improvements post-treatment (P = 0.0039, ES = 0.91) compared to baseline. Respiration rates and oxygen saturation levels that were within the normal range at the baseline remained unchanged at the end of the study (EOS). Paired comparison between baseline and EOS for short-form-36 health survey questionnaire (SF-36) scores also showed improved quality-of-life with significant improvements in individual SF-36 evaluations. Mostly mild AEs were reported during the study period with no incidence of serious AEs. Also, no detrimental effects in laboratory values were seen.
The results of the expanded access program indicated that treatment with autologous HB-adMSCs resulted in significant improvements in the signs and symptoms associated with post-COVID-19 syndrome as assessed by VAS and FAS scores. Additionally, improvements in the patients' quality-of-life as demonstrated using SF-36 scores that also showed significant improvements in individual scaled scores. Overall, administration of multiple infusions of autologous HB-adMSCs is safe and efficacious for improvements in the quality-of life of patients with post-COVID-19 syndrome.
Clinical trial registration number: NCT04798066. Registered on March 15, 2021. ( https://clinicaltrials.gov/ct2/show/NCT04798066?term=hope+biosciences&cond=Post-COVID-19+Syndrome&draw=2&rank=2 ).
新型冠状病毒的不断变异继续推动着疫情的发展。该病毒不仅影响人类的呼吸系统，还会影响其他身体系统，导致疾病幸存者出现多种后遗症，表现为新冠后综合征或长新冠。本方案利用 Hope Biosciences 的自体脂肪来源间充质干细胞（HB-adMSCs），评估 HB-adMSC 治疗改善新冠后综合征相关症状和体征的安全性和有效性。
本项研究纳入了 10 名符合条件的新冠后综合征患者，他们接受了 5 次 HB-adMSC（每次 2×10 个自体细胞）静脉输注，分别在第 0、2、6、10 和 14 周进行，随访至第 18 周，研究结束时为第 40 周。安全性评估包括不良事件和严重不良事件的发生率，以及血液学、肝脏和肾功能的实验室指标。通过生活质量评估、疲劳评估、症状视觉模拟量表（VAS）和呼吸及血氧饱和度监测来评估疗效。
与基线相比，治疗后 VAS 评分和疲劳评估评分（FAS）显著改善（P=0.0039，ES=0.91）。基线时处于正常范围内的呼吸频率和血氧饱和度在研究结束时（EOS）保持不变。基线和 EOS 之间的简短 36 项健康调查问卷（SF-36）评分的配对比较也显示出生活质量的改善，SF-36 各评估的评分也有显著改善。研究期间报告了大多数为轻度的不良事件，没有严重不良事件的发生。此外，实验室指标也没有出现不良变化。
扩展准入方案的结果表明，自体 HB-adMSCs 治疗可显著改善新冠后综合征相关的体征和症状，VAS 和 FAS 评分评估结果表明，患者的生活质量也得到了改善，SF-36 评分也显示出各评分的显著改善。总体而言，多次输注自体 HB-adMSCs 是安全有效的，可提高新冠后综合征患者的生活质量。
临床试验注册号：NCT04798066。注册日期：2021 年 3 月 15 日。（临床试验.gov/ct2/show/NCT04798066？term=hope+biosciences&cond=Post-COVID-19+Syndrome&draw=2&rank=2）。
