drugset / Trial / NCT06304623
SVF for Treating Pulmonary Fibrosis Post COVID-19
Phase 1
Completed
40 enrolled
Michael H Carstens
Ministerio de Salud de Nicaragua · collabNational Autonomous University of Nicaragua · collabWake Forest University · collab
NaSingle-groupOpen-labelTreatment
Summary
General description of the study This is a prospective, multicenter, expanded access interventional study of subjects recovered from COVID-19 pneumonia to assess their response to intravenous administration of adipose-derived autologous SVF. Primary objective The purpose of this study was to evaluate the safety of single intravenous injections of autologous adipose-derived SVF produced using the GID SVF-2 device system for the treatment of secondary respiratory distress associated with COVID-19. Secondary objective To evaluate the efficacy of the initial treatment with SVF IV.
Timeline
- Start
- 2020-05-05
- Primary completion
- 2024-03-01
- Completion
- 2024-03-01
Publications
- Background Coronaviridae Study Group of the International Committee on Taxonomy of Viruses. The species Severe acute respiratory syndrome-related coronavirus: classifying 2019-nCoV and naming it SARS-CoV-2. Nat Microbiol. 2020 Apr;5(4):536-544. doi: 10.1038/s41564-020-0695-z. Epub 2020 Mar 2.
- Background WHO Director-General's opening remarks at the media briefing on COVID-19 - 11 March2020. https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the- media-briefing-on-covid-19---11-march-2020. Published 2020
- Background Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
- Background Jiang S, Du L, Shi Z. An emerging coronavirus causing pneumonia outbreak in Wuhan, China: calling for developing therapeutic and prophylactic strategies. Emerg Microbes Infect. 2020 Jan 31;9(1):275-277. doi: 10.1080/22221751.2020.1723441. eCollection 2020. No abstract available.
- Background Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.
- Background Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
- Background Weiss P, Murdoch DR. Clinical course and mortality risk of severe COVID-19. Lancet. 2020 Mar 28;395(10229):1014-1015. doi: 10.1016/S0140-6736(20)30633-4. Epub 2020 Mar 17. No abstract available.
- Background Pittenger MF, Discher DE, Peault BM, Phinney DG, Hare JM, Caplan AI. Mesenchymal stem cell perspective: cell biology to clinical progress. NPJ Regen Med. 2019 Dec 2;4:22. doi: 10.1038/s41536-019-0083-6. eCollection 2019.
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- Background Le Blanc K, Davies LC. Mesenchymal stromal cells and the innate immune response. Immunol Lett. 2015 Dec;168(2):140-6. doi: 10.1016/j.imlet.2015.05.004. Epub 2015 May 15.
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- Background Nguyen A, Guo J, Banyard DA, Fadavi D, Toranto JD, Wirth GA, Paydar KZ, Evans GR, Widgerow AD. Stromal vascular fraction: A regenerative reality? Part 1: Current concepts and review of the literature. J Plast Reconstr Aesthet Surg. 2016 Feb;69(2):170-9. doi: 10.1016/j.bjps.2015.10.015. Epub 2015 Oct 31.
- Background Brown, P, Katz AJ. Adipose -derived stem cells In: Atala A (ed). Textbook of Regenerative Medicine Elsevier, 3rd ed. 2019, pp.
- Background Kapur SK, Dos-Anjos Vilaboa S, Llull R, Katz AJ. Adipose tissue and stem/progenitor cells: discovery and development. Clin Plast Surg. 2015 Apr;42(2):155-67. doi: 10.1016/j.cps.2014.12.010.
- Background Guo J, Nguyen A, Banyard DA, Fadavi D, Toranto JD, Wirth GA, Paydar KZ, Evans GR, Widgerow AD. Stromal vascular fraction: A regenerative reality? Part 2: Mechanisms of regenerative action. J Plast Reconstr Aesthet Surg. 2016 Feb;69(2):180-8. doi: 10.1016/j.bjps.2015.10.014. Epub 2015 Oct 24.
- Background Regmi S, Pathak S, Kim JO, Yong CS, Jeong JH. Mesenchymal stem cell therapy for the treatment of inflammatory diseases: Challenges, opportunities, and future perspectives. Eur J Cell Biol. 2019 Dec;98(5-8):151041. doi: 10.1016/j.ejcb.2019.04.002. Epub 2019 Apr 14.
- Background Limper AH. Safety of IV Human Mesenchymal Stem Cells in Patients With Idiopathic Pulmonary Fibrosis. Chest. 2017 May;151(5):951-952. doi: 10.1016/j.chest.2016.12.015. No abstract available.
- Background Comella K, Blas JAP, Ichim T, Lopez J, Limon J, Moreno RC. Autologous Stromal Vascular Fraction in the Intravenous Treatment of End-Stage Chronic Obstructive Pulmonary Disease: A Phase I Trial of Safety and Tolerability. J Clin Med Res. 2017 Aug;9(8):701-708. doi: 10.14740/jocmr3072w. Epub 2017 Jul 1.
- Background Michalek J, Vrablikova A, Heinrich KG, Dudasova Z. Stromal Vascular Fraction Cell Therapy for a Stroke Patient-Cure without Side Effects. Brain Sci. 2019 Mar 6;9(3):55. doi: 10.3390/brainsci9030055.
- Background Turner AJ, Hiscox JA, Hooper NM. ACE2: from vasopeptidase to SARS virus receptor. Trends Pharmacol Sci. 2004 Jun;25(6):291-4. doi: 10.1016/j.tips.2004.04.001.
- Background Leng Z, Zhu R, Hou W, Feng Y, Yang Y, Han Q, Shan G, Meng F, Du D, Wang S, Fan J, Wang W, Deng L, Shi H, Li H, Hu Z, Zhang F, Gao J, Liu H, Li X, Zhao Y, Yin K, He X, Gao Z, Wang Y, Yang B, Jin R, Stambler I, Lim LW, Su H, Moskalev A, Cano A, Chakrabarti S, Min KJ, Ellison-Hughes G, Caruso C, Jin K, Zhao RC. Transplantation of ACE2- Mesenchymal Stem Cells Improves the Outcome of Patients with COVID-19 Pneumonia. Aging Dis. 2020 Mar 9;11(2):216-228. doi: 10.14336/AD.2020.0228. eCollection 2020 Apr.
- Background Caplan AI, Correa D. The MSC: an injury drugstore. Cell Stem Cell. 2011 Jul 8;9(1):11-5. doi: 10.1016/j.stem.2011.06.008.
- Background Gutta S, Grobe N, Kumbaji M, Osman H, Saklayen M, Li G, Elased KM. Increased urinary angiotensin converting enzyme 2 and neprilysin in patients with type 2 diabetes. Am J Physiol Renal Physiol. 2018 Aug 1;315(2):F263-F274. doi: 10.1152/ajprenal.00565.2017. Epub 2018 Mar 21.
- Background Giannandrea M, Parks WC. Diverse functions of matrix metalloproteinases during fibrosis. Dis Model Mech. 2014 Feb;7(2):193-203. doi: 10.1242/dmm.012062.
- Background Pardo A, Cabrera S, Maldonado M, Selman M. Role of matrix metalloproteinases in the pathogenesis of idiopathic pulmonary fibrosis. Respir Res. 2016 Mar 4;17:23. doi: 10.1186/s12931-016-0343-6.
- Background Crestani B, Marchand-Adam S, Quesnel C, Plantier L, Borensztajn K, Marchal J, Mailleux A, Soler P, Dehoux M. Hepatocyte growth factor and lung fibrosis. Proc Am Thorac Soc. 2012 Jul;9(3):158-63. doi: 10.1513/pats.201202-018AW.
- Background Castro LL, Kitoko JZ, Xisto DG, Olsen PC, Guedes HLM, Morales MM, Lopes-Pacheco M, Cruz FF, Rocco PRM. Multiple doses of adipose tissue-derived mesenchymal stromal cells induce immunosuppression in experimental asthma. Stem Cells Transl Med. 2020 Feb;9(2):250-260. doi: 10.1002/sctm.19-0120. Epub 2019 Nov 20.
- Background Zakhari JS, Zabonick J, Gettler B, Williams SK. Vasculogenic and angiogenic potential of adipose stromal vascular fraction cell populations in vitro. In Vitro Cell Dev Biol Anim. 2018 Jan;54(1):32-40. doi: 10.1007/s11626-017-0213-7. Epub 2017 Dec 1.
- Background Carstens MH, Gomez A, Cortes R, Turner E, Perez C, Ocon M, Correa D. Non-reconstructable peripheral vascular disease of the lower extremity in ten patients treated with adipose-derived stromal vascular fraction cells. Stem Cell Res. 2017 Jan;18:14-21. doi: 10.1016/j.scr.2016.12.001. Epub 2016 Dec 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Autologous adipose-derived SVF | Cell therapy | 4.5e+07 cells | Intravenous |