drugset / Trial / NCT05669261
Treatment of Long COVID Symptoms Utilizing Autologous Stem Cells Following COVID-19 Infection
RandomizedCrossoverTriple-blindTreatment
Summary
The project is described as a Phase 1 Clinical Safety Study intended to provide preliminary assessments of the safety, tolerability, and secondarily to be vigilant for signals of amelioration of symptoms associated with Post-Acute Sequelae of SARS-CoV-2 infection
Timeline
- Start
- 2023-08-01
- Primary completion
- 2023-12-31
- Completion
- 2024-02-01
Publications
- Background Nasserie T, Hittle M, Goodman SN. Assessment of the Frequency and Variety of Persistent Symptoms Among Patients With COVID-19: A Systematic Review. JAMA Netw Open. 2021 May 3;4(5):e2111417. doi: 10.1001/jamanetworkopen.2021.11417.
- Background Alkodaymi MS, Omrani OA, Ashraf N, Shaar BA, Almamlouk R, Riaz M, Obeidat M, Obeidat Y, Gerberi D, Taha RM, Kashour Z, Kashour T, Berbari EF, Alkattan K, Tleyjeh IM. Prevalence of post-acute COVID-19 syndrome symptoms at different follow-up periods: a systematic review and meta-analysis. Clin Microbiol Infect. 2022 May;28(5):657-666. doi: 10.1016/j.cmi.2022.01.014. Epub 2022 Feb 3.
- Background Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.
- Background Nehme M, Braillard O, Alcoba G, Aebischer Perone S, Courvoisier D, Chappuis F, Guessous I; COVICARE TEAM. COVID-19 Symptoms: Longitudinal Evolution and Persistence in Outpatient Settings. Ann Intern Med. 2021 May;174(5):723-725. doi: 10.7326/M20-5926. Epub 2020 Dec 8. No abstract available.
- Background Garrigues E, Janvier P, Kherabi Y, Le Bot A, Hamon A, Gouze H, Doucet L, Berkani S, Oliosi E, Mallart E, Corre F, Zarrouk V, Moyer JD, Galy A, Honsel V, Fantin B, Nguyen Y. Post-discharge persistent symptoms and health-related quality of life after hospitalization for COVID-19. J Infect. 2020 Dec;81(6):e4-e6. doi: 10.1016/j.jinf.2020.08.029. Epub 2020 Aug 25.
- Background Ladds E, Rushforth A, Wieringa S, Taylor S, Rayner C, Husain L, Greenhalgh T. Persistent symptoms after Covid-19: qualitative study of 114 "long Covid" patients and draft quality principles for services. BMC Health Serv Res. 2020 Dec 20;20(1):1144. doi: 10.1186/s12913-020-06001-y.
- Background Huang C, Huang L, Wang Y, Li X, Ren L, Gu X, Kang L, Guo L, Liu M, Zhou X, Luo J, Huang Z, Tu S, Zhao Y, Chen L, Xu D, Li Y, Li C, Peng L, Li Y, Xie W, Cui D, Shang L, Fan G, Xu J, Wang G, Wang Y, Zhong J, Wang C, Wang J, Zhang D, Cao B. 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study. Lancet. 2021 Jan 16;397(10270):220-232. doi: 10.1016/S0140-6736(20)32656-8. Epub 2021 Jan 8.
- Background Jin Y, Ji W, Yang H, Chen S, Zhang W, Duan G. Endothelial activation and dysfunction in COVID-19: from basic mechanisms to potential therapeutic approaches. Signal Transduct Target Ther. 2020 Dec 24;5(1):293. doi: 10.1038/s41392-020-00454-7.
- Background Bocci M, Oudenaarden C, Saenz-Sarda X, Simren J, Eden A, Sjolund J, Moller C, Gisslen M, Zetterberg H, Englund E, Pietras K. Infection of Brain Pericytes Underlying Neuropathology of COVID-19 Patients. Int J Mol Sci. 2021 Oct 27;22(21):11622. doi: 10.3390/ijms222111622.
- Background Cardot-Leccia N, Hubiche T, Dellamonica J, Burel-Vandenbos F, Passeron T. Pericyte alteration sheds light on micro-vasculopathy in COVID-19 infection. Intensive Care Med. 2020 Sep;46(9):1777-1778. doi: 10.1007/s00134-020-06147-7. Epub 2020 Jun 12. No abstract available.
- Background Jones OY, Yeralan S. Is Long COVID a State of Systemic Pericyte Disarray? J Clin Med. 2022 Jan 24;11(3):572. doi: 10.3390/jcm11030572.
- Background Munir H, McGettrick HM. Mesenchymal Stem Cell Therapy for Autoimmune Disease: Risks and Rewards. Stem Cells Dev. 2015 Sep 15;24(18):2091-100. doi: 10.1089/scd.2015.0008. Epub 2015 Jul 28.
- Background Mezey E, Nemeth K. Mesenchymal stem cells and infectious diseases: Smarter than drugs. Immunol Lett. 2015 Dec;168(2):208-14. doi: 10.1016/j.imlet.2015.05.020. Epub 2015 Jun 4.
- Background Arabpour E, Khoshdel S, Tabatabaie N, Akhgarzad A, Zangiabadian M, Nasiri MJ. Stem Cells Therapy for COVID-19: A Systematic Review and Meta-Analysis. Front Med (Lausanne). 2021 Nov 29;8:737590. doi: 10.3389/fmed.2021.737590. eCollection 2021.
- Background Golchin A, Seyedjafari E, Ardeshirylajimi A. Mesenchymal Stem Cell Therapy for COVID-19: Present or Future. Stem Cell Rev Rep. 2020 Jun;16(3):427-433. doi: 10.1007/s12015-020-09973-w.
- Background Worm-Smeitink M, Gielissen M, Bloot L, van Laarhoven HWM, van Engelen BGM, van Riel P, Bleijenberg G, Nikolaus S, Knoop H. The assessment of fatigue: Psychometric qualities and norms for the Checklist individual strength. J Psychosom Res. 2017 Jul;98:40-46. doi: 10.1016/j.jpsychores.2017.05.007. Epub 2017 May 8.
- Background Plash WB, Diedrich A, Biaggioni I, Garland EM, Paranjape SY, Black BK, Dupont WD, Raj SR. Diagnosing postural tachycardia syndrome: comparison of tilt testing compared with standing haemodynamics. Clin Sci (Lond). 2013 Jan;124(2):109-14. doi: 10.1042/CS20120276.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Autologous adipose-derived mesenchymal stem cells | Cell therapy | 1.5e+08 cells | — |