Stem Cell Study for Long COVID-19 Neurological Symptoms

Summary

The purpose of this research study is to test the safety and benefit of a human cord blood derived stem cell infusion as a treatment for individuals with post COVID-19 neurological problems. Participants in the study will have 6 clinic visits over a 12 to 14 mo. period with each visit lasting 2 to 6 hours. Participants will receive 1 stem cell infusion at study visit #3. Participants will have a brain PET and MRI scan at the baseline and 6mo. post-infusion visits. Follow-up safety assessments will be conducted at 6mo. and 1yr. after the stem cell infusion.

Timeline

Start

2024-01

Primary completion

2025-12

Completion

2026-02

Publications

• Results Aiyegbusi OL, Hughes SE, Turner G, Rivera SC, McMullan C, Chandan JS, Haroon S, Price G, Davies EH, Nirantharakumar K, Sapey E, Calvert MJ; TLC Study Group. Symptoms, complications and management of long COVID: a review. J R Soc Med. 2021 Sep;114(9):428-442. doi: 10.1177/01410768211032850. Epub 2021 Jul 15.
• Results Cha C, Baek G. Symptoms and management of long COVID: A scoping review. J Clin Nurs. 2024 Jan;33(1):11-28. doi: 10.1111/jocn.16150. Epub 2021 Dec 15.
• Results Costas-Carrera A, Sanchez-Rodriguez MM, Canizares S, Ojeda A, Martin-Villalba I, Prime-Tous M, Rodriguez-Rey MA, Segu X, Valdesoiro-Pulido F, Borras R, Peri JM, Vieta E. Neuropsychological functioning in post-ICU patients after severe COVID-19 infection: The role of cognitive reserve. Brain Behav Immun Health. 2022 May;21:100425. doi: 10.1016/j.bbih.2022.100425. Epub 2022 Feb 7.
• Results Davis HE, Assaf GS, McCorkell L, Wei H, Low RJ, Re'em Y, Redfield S, Austin JP, Akrami A. Characterizing long COVID in an international cohort: 7 months of symptoms and their impact. EClinicalMedicine. 2021 Aug;38:101019. doi: 10.1016/j.eclinm.2021.101019. Epub 2021 Jul 15.
• Results Del Rio C, Collins LF, Malani P. Long-term Health Consequences of COVID-19. JAMA. 2020 Nov 3;324(17):1723-1724. doi: 10.1001/jama.2020.19719. No abstract available.
• Results Doykov I, Hallqvist J, Gilmour KC, Grandjean L, Mills K, Heywood WE. 'The long tail of Covid-19' - The detection of a prolonged inflammatory response after a SARS-CoV-2 infection in asymptomatic and mildly affected patients. F1000Res. 2020 Nov 19;9:1349. doi: 10.12688/f1000research.27287.2. eCollection 2020.
• Results Graham EL, Clark JR, Orban ZS, Lim PH, Szymanski AL, Taylor C, DiBiase RM, Jia DT, Balabanov R, Ho SU, Batra A, Liotta EM, Koralnik IJ. Persistent neurologic symptoms and cognitive dysfunction in non-hospitalized Covid-19 "long haulers". Ann Clin Transl Neurol. 2021 May;8(5):1073-1085. doi: 10.1002/acn3.51350. Epub 2021 Mar 30.
• Results Hayes LD, Ingram J, Sculthorpe NF. More Than 100 Persistent Symptoms of SARS-CoV-2 (Long COVID): A Scoping Review. Front Med (Lausanne). 2021 Nov 1;8:750378. doi: 10.3389/fmed.2021.750378. eCollection 2021.
• Results Higgins V, Sohaei D, Diamandis EP, Prassas I. COVID-19: from an acute to chronic disease? Potential long-term health consequences. Crit Rev Clin Lab Sci. 2021 Aug;58(5):297-310. doi: 10.1080/10408363.2020.1860895. Epub 2020 Dec 21.
• Results 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.
• Results Ikawa M, Lohith TG, Shrestha S, Telu S, Zoghbi SS, Castellano S, Taliani S, Da Settimo F, Fujita M, Pike VW, Innis RB; Biomarkers Consortium Radioligand Project Team. 11C-ER176, a Radioligand for 18-kDa Translocator Protein, Has Adequate Sensitivity to Robustly Image All Three Affinity Genotypes in Human Brain. J Nucl Med. 2017 Feb;58(2):320-325. doi: 10.2967/jnumed.116.178996. Epub 2016 Nov 17.
• Results Kayaaslan B, Eser F, Kalem AK, Kaya G, Kaplan B, Kacar D, Hasanoglu I, Coskun B, Guner R. Post-COVID syndrome: A single-center questionnaire study on 1007 participants recovered from COVID-19. J Med Virol. 2021 Dec;93(12):6566-6574. doi: 10.1002/jmv.27198. Epub 2021 Jul 28.
• Results Lemhofer C, Gutenbrunner C, Schiller J, Loudovici-Krug D, Best N, Bokel A, Sturm C. Assessment of rehabilitation needs in patients after COVID-19: Development of the COVID-19-rehabilitation needs survey. J Rehabil Med. 2021 Apr 27;53(4):jrm00183. doi: 10.2340/16501977-2818.
• Results Mandal S, Barnett J, Brill SE, Brown JS, Denneny EK, Hare SS, Heightman M, Hillman TE, Jacob J, Jarvis HC, Lipman MCI, Naidu SB, Nair A, Porter JC, Tomlinson GS, Hurst JR; ARC Study Group. 'Long-COVID': a cross-sectional study of persisting symptoms, biomarker and imaging abnormalities following hospitalisation for COVID-19. Thorax. 2021 Apr;76(4):396-398. doi: 10.1136/thoraxjnl-2020-215818. Epub 2020 Nov 10.
• Results Malik P, Patel U, Mehta D, Patel N, Kelkar R, Akrmah M, Gabrilove JL, Sacks H. Biomarkers and outcomes of COVID-19 hospitalisations: systematic review and meta-analysis. BMJ Evid Based Med. 2021 Jun;26(3):107-108. doi: 10.1136/bmjebm-2020-111536. Epub 2020 Sep 15.
• Results O'Connor RJ, Preston N, Parkin A, Makower S, Ross D, Gee J, Halpin SJ, Horton M, Sivan M. The COVID-19 Yorkshire Rehabilitation Scale (C19-YRS): Application and psychometric analysis in a post-COVID-19 syndrome cohort. J Med Virol. 2022 Mar;94(3):1027-1034. doi: 10.1002/jmv.27415. Epub 2021 Nov 5.
• Results Ogier M, Andeol G, Sagui E, Dal Bo G. How to detect and track chronic neurologic sequelae of COVID-19? Use of auditory brainstem responses and neuroimaging for long-term patient follow-up. Brain Behav Immun Health. 2020 May;5:100081. doi: 10.1016/j.bbih.2020.100081. Epub 2020 May 15.
• Results Paterson RW, Brown RL, Benjamin L, Nortley R, Wiethoff S, Bharucha T, Jayaseelan DL, Kumar G, Raftopoulos RE, Zambreanu L, Vivekanandam V, Khoo A, Geraldes R, Chinthapalli K, Boyd E, Tuzlali H, Price G, Christofi G, Morrow J, McNamara P, McLoughlin B, Lim ST, Mehta PR, Levee V, Keddie S, Yong W, Trip SA, Foulkes AJM, Hotton G, Miller TD, Everitt AD, Carswell C, Davies NWS, Yoong M, Attwell D, Sreedharan J, Silber E, Schott JM, Chandratheva A, Perry RJ, Simister R, Checkley A, Longley N, Farmer SF, Carletti F, Houlihan C, Thom M, Lunn MP, Spillane J, Howard R, Vincent A, Werring DJ, Hoskote C, Jager HR, Manji H, Zandi MS. The emerging spectrum of COVID-19 neurology: clinical, radiological and laboratory findings. Brain. 2020 Oct 1;143(10):3104-3120. doi: 10.1093/brain/awaa240.
• Results Scherlinger M, Felten R, Gallais F, Nazon C, Chatelus E, Pijnenburg L, Mengin A, Gras A, Vidailhet P, Arnould-Michel R, Bibi-Triki S, Carapito R, Trouillet-Assant S, Perret M, Belot A, Bahram S, Arnaud L, Gottenberg JE, Fafi-Kremer S, Sibilia J. Refining "Long-COVID" by a Prospective Multimodal Evaluation of Patients with Long-Term Symptoms Attributed to SARS-CoV-2 Infection. Infect Dis Ther. 2021 Sep;10(3):1747-1763. doi: 10.1007/s40121-021-00484-w. Epub 2021 Jul 10.
• Results Tran VT, Riveros C, Clepier B, Desvarieux M, Collet C, Yordanov Y, Ravaud P. Development and Validation of the Long Coronavirus Disease (COVID) Symptom and Impact Tools: A Set of Patient-Reported Instruments Constructed From Patients' Lived Experience. Clin Infect Dis. 2022 Jan 29;74(2):278-287. doi: 10.1093/cid/ciab352.
• Results Townsend L, Dowds J, O'Brien K, Sheill G, Dyer AH, O'Kelly B, Hynes JP, Mooney A, Dunne J, Ni Cheallaigh C, O'Farrelly C, Bourke NM, Conlon N, Martin-Loeches I, Bergin C, Nadarajan P, Bannan C. Persistent Poor Health after COVID-19 Is Not Associated with Respiratory Complications or Initial Disease Severity. Ann Am Thorac Soc. 2021 Jun;18(6):997-1003. doi: 10.1513/AnnalsATS.202009-1175OC.

Drugs

Indications