Study to Explore the Safety and Feasibility of Allogeneic Young Plasma Infusion in Older Adults
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04241159|
Recruitment Status : Withdrawn (Protocol required revisions and application was withdrawn from the IRB.)
First Posted : January 27, 2020
Last Update Posted : May 22, 2020
Wake Forest University Health Sciences
Information provided by (Responsible Party):
Wake Forest University Health Sciences
No Study Results Posted on ClinicalTrials.gov for this Study
Study was withdrawn before participants were enrolled.
|Recruitment Status :||Withdrawn|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2020|
Aging Well in the 21st Century: Strategic Directions for Research on Aging. [cited 2018 8/10/18]; Available from: https://www.nia.nih.gov/about/aging-well-21st-century-strategic-directions-research-aging.
Olivieri F, Capri M, Bonafè M, Morsiani C, Jung HJ, Spazzafumo L, Viña J, Suh Y. Circulating miRNAs and miRNA shuttles as biomarkers: Perspective trajectories of healthy and unhealthy aging. Mech Ageing Dev. 2017 Jul;165(Pt B):162-170. doi: 10.1016/j.mad.2016.12.004. Epub 2016 Dec 13. Review.
Hayflick L. Biological aging is no longer an unsolved problem. Ann N Y Acad Sci. 2007 Apr;1100:1-13. Review.
Bilder, G., Human biological aging : from macromolecules to organ-systems. 2016, Hoboken, New Jersey: Wiley Blackwell. ix, 330 pages.
Hatse S, Brouwers B, Dalmasso B, Laenen A, Kenis C, Schöffski P, Wildiers H. Circulating MicroRNAs as easy-to-measure aging biomarkers in older breast cancer patients: correlation with chronological age but not with fitness/frailty status. PLoS One. 2014 Oct 21;9(10):e110644. doi: 10.1371/journal.pone.0110644. eCollection 2014.
Kadota T, Fujita Y, Yoshioka Y, Araya J, Kuwano K, Ochiya T. Emerging role of extracellular vesicles as a senescence-associated secretory phenotype: Insights into the pathophysiology of lung diseases. Mol Aspects Med. 2018 Apr;60:92-103. doi: 10.1016/j.mam.2017.11.005. Epub 2017 Nov 20. Review.
Sinha M, Jang YC, Oh J, Khong D, Wu EY, Manohar R, Miller C, Regalado SG, Loffredo FS, Pancoast JR, Hirshman MF, Lebowitz J, Shadrach JL, Cerletti M, Kim MJ, Serwold T, Goodyear LJ, Rosner B, Lee RT, Wagers AJ. Restoring systemic GDF11 levels reverses age-related dysfunction in mouse skeletal muscle. Science. 2014 May 9;344(6184):649-52. doi: 10.1126/science.1251152. Epub 2014 May 5.
Loffredo FS, Steinhauser ML, Jay SM, Gannon J, Pancoast JR, Yalamanchi P, Sinha M, Dall'Osso C, Khong D, Shadrach JL, Miller CM, Singer BS, Stewart A, Psychogios N, Gerszten RE, Hartigan AJ, Kim MJ, Serwold T, Wagers AJ, Lee RT. Growth differentiation factor 11 is a circulating factor that reverses age-related cardiac hypertrophy. Cell. 2013 May 9;153(4):828-39. doi: 10.1016/j.cell.2013.04.015.
Middeldorp J, Lehallier B, Villeda SA, Miedema SS, Evans E, Czirr E, Zhang H, Luo J, Stan T, Mosher KI, Masliah E, Wyss-Coray T. Preclinical Assessment of Young Blood Plasma for Alzheimer Disease. JAMA Neurol. 2016 Nov 1;73(11):1325-1333. doi: 10.1001/jamaneurol.2016.3185.
Katsimpardi L, Litterman NK, Schein PA, Miller CM, Loffredo FS, Wojtkiewicz GR, Chen JW, Lee RT, Wagers AJ, Rubin LL. Vascular and neurogenic rejuvenation of the aging mouse brain by young systemic factors. Science. 2014 May 9;344(6184):630-4. doi: 10.1126/science.1251141. Epub 2014 May 5.
Upadhya B, Pisani B, Kitzman DW. Evolution of a Geriatric Syndrome: Pathophysiology and Treatment of Heart Failure with Preserved Ejection Fraction. J Am Geriatr Soc. 2017 Nov;65(11):2431-2440. doi: 10.1111/jgs.15141. Review.
Haykowsky MJ, Nicklas BJ, Brubaker PH, Hundley WG, Brinkley TE, Upadhya B, Becton JT, Nelson MD, Chen H, Kitzman DW. Regional Adipose Distribution and its Relationship to Exercise Intolerance in Older Obese Patients Who Have Heart Failure With Preserved Ejection Fraction. JACC Heart Fail. 2018 Aug;6(8):640-649. doi: 10.1016/j.jchf.2018.06.002. Epub 2018 Jul 11.
Kitzman DW, Little WC, Brubaker PH, Anderson RT, Hundley WG, Marburger CT, Brosnihan B, Morgan TM, Stewart KP. Pathophysiological characterization of isolated diastolic heart failure in comparison to systolic heart failure. JAMA. 2002 Nov 6;288(17):2144-50.
Haykowsky MJ, Tomczak CR, Scott JM, Paterson DI, Kitzman DW. Determinants of exercise intolerance in patients with heart failure and reduced or preserved ejection fraction. J Appl Physiol (1985). 2015 Sep 15;119(6):739-44. doi: 10.1152/japplphysiol.00049.2015. Epub 2015 Apr 24. Review.
Stehle JR Jr, Leng X, Kitzman DW, Nicklas BJ, Kritchevsky SB, High KP. Lipopolysaccharide-binding protein, a surrogate marker of microbial translocation, is associated with physical function in healthy older adults. J Gerontol A Biol Sci Med Sci. 2012 Nov;67(11):1212-8. doi: 10.1093/gerona/gls178. Epub 2012 Sep 7.
Shah SJ, Kitzman DW, Borlaug BA, van Heerebeek L, Zile MR, Kass DA, Paulus WJ. Phenotype-Specific Treatment of Heart Failure With Preserved Ejection Fraction: A Multiorgan Roadmap. Circulation. 2016 Jul 5;134(1):73-90. doi: 10.1161/CIRCULATIONAHA.116.021884. Review.
Kitzman DW, Upadhya B, Reeves G. Hospitalizations and Prognosis in Elderly Patients With Heart Failure and Preserved Ejection Fraction: Time to Treat the Whole Patient. JACC Heart Fail. 2015 Jun;3(6):442-444. doi: 10.1016/j.jchf.2015.01.009. Epub 2015 May 14.
Kitzman DW, Brubaker PH, Morgan TM, Stewart KP, Little WC. Exercise training in older patients with heart failure and preserved ejection fraction: a randomized, controlled, single-blind trial. Circ Heart Fail. 2010 Nov;3(6):659-67. doi: 10.1161/CIRCHEARTFAILURE.110.958785. Epub 2010 Sep 17.
Kitzman DW, Brubaker P, Morgan T, Haykowsky M, Hundley G, Kraus WE, Eggebeen J, Nicklas BJ. Effect of Caloric Restriction or Aerobic Exercise Training on Peak Oxygen Consumption and Quality of Life in Obese Older Patients With Heart Failure With Preserved Ejection Fraction: A Randomized Clinical Trial. JAMA. 2016 Jan 5;315(1):36-46. doi: 10.1001/jama.2015.17346.
Triposkiadis F, Xanthopoulos A, Butler J. Cardiovascular Aging and Heart Failure: JACC Review Topic of the Week. J Am Coll Cardiol. 2019 Aug 13;74(6):804-813. doi: 10.1016/j.jacc.2019.06.053. Review.
Justice JN, Ferrucci L, Newman AB, Aroda VR, Bahnson JL, Divers J, Espeland MA, Marcovina S, Pollak MN, Kritchevsky SB, Barzilai N, Kuchel GA. A framework for selection of blood-based biomarkers for geroscience-guided clinical trials: report from the TAME Biomarkers Workgroup. Geroscience. 2018 Dec;40(5-6):419-436. doi: 10.1007/s11357-018-0042-y. Epub 2018 Aug 27. Review.
Savarese, D. Common Terminology Criteria for Adverse Events. 2019 [cited 2019 2019]; Available from: https://www.uptodate.com/contents/common-terminology-criteria-for-adverse-events?search=Common%20Terminology%20Criteria%20for%20Adverse%20Events.&source=search_result&selectedTitle=1~38&usage_type=default&display_rank=1
Nicklas BJ, Wang X, You T, Lyles MF, Demons J, Easter L, Berry MJ, Lenchik L, Carr JJ. Effect of exercise intensity on abdominal fat loss during calorie restriction in overweight and obese postmenopausal women: a randomized, controlled trial. Am J Clin Nutr. 2009 Apr;89(4):1043-52. doi: 10.3945/ajcn.2008.26938. Epub 2009 Feb 11.
Misquita NA, Davis DC, Dobrovolny CL, Ryan AS, Dennis KE, Nicklas BJ. Applicability of maximal oxygen consumption criteria in obese, postmenopausal women. J Womens Health Gend Based Med. 2001 Nov;10(9):879-85.
Randolph C, Tierney MC, Mohr E, Chase TN. The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): preliminary clinical validity. J Clin Exp Neuropsychol. 1998 Jun;20(3):310-9.
Hobart MP, Goldberg R, Bartko JJ, Gold JM. Repeatable battery for the assessment of neuropsychological status as a screening test in schizophrenia, II: convergent/discriminant validity and diagnostic group comparisons. Am J Psychiatry. 1999 Dec;156(12):1951-7.
Silvergleid, A.J. Clinical Use of Plasma Components. [cited 2019]/ Available from: https://www.uptodate.com/contents/clinical-use-of-plasma-components
The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study (PLASMA). Available from: https://clinicaltrials.gov/ct2/show/NCT02256306?term=PLASMA&rank=1
Reversing Epigenetic & Other Markers of Senescence by Transfusing Young Plasma To Older Human Subjects (RESET-YOUTH). Available from: https://clinicaltrials.gov/ct2/show/NCT03353597?term=Reset-YOuth&rank=1
Fresh Frozen Plasma: Indications and Risks: NIH Consensus Development Conference Statement. 1984 9/11/2018]; Available from: https://consensus.nih.gov/1984/1984FrozenPlasma045html.htm.
Silvergleid, A.J. Approach to the patient with a suspected acute transfusion reaction. 4/23/18]; Available from: https://www.uptodate.com/contents/approach-to-the-patient-with-a-suspected-acute-transfusion-reaction
Diane, S. Common Terminology Criteria for Adverse Events. April 23, 2018; Available from: http://www.uptodate.com