Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-29 @ 4:46 AM
Study NCT ID:
NCT05573412
Status:
UNKNOWN
Last Update Posted:
2022-10-10
First Post:
2022-10-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Proliferative Potential of H-PBSC Based on Demographics and Cryopreservation Time
Sponsor:
Organization:
Raw JSON
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Epub 2013 Feb 4.'}, {'pmid': '34265388', 'type': 'BACKGROUND', 'citation': 'Saw KY, Anz AW, Ng RC, Jee CS, Low SF, Dorvault C, Johnson KB. Arthroscopic Subchondral Drilling Followed by Injection of Peripheral Blood Stem Cells and Hyaluronic Acid Showed Improved Outcome Compared to Hyaluronic Acid and Physiotherapy for Massive Knee Chondral Defects: A Randomized Controlled Trial. Arthroscopy. 2021 Aug;37(8):2502-2517. doi: 10.1016/j.arthro.2021.01.067. Epub 2021 Jul 12.'}, {'pmid': '3264199', 'type': 'BACKGROUND', 'citation': 'Duhrsen U, Villeval JL, Boyd J, Kannourakis G, Morstyn G, Metcalf D. Effects of recombinant human granulocyte colony-stimulating factor on hematopoietic progenitor cells in cancer patients. Blood. 1988 Dec;72(6):2074-81.'}, {'pmid': '7679596', 'type': 'BACKGROUND', 'citation': 'Matsunaga T, Sakamaki S, Kohgo Y, Ohi S, Hirayama Y, Niitsu Y. 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Heterogeneity of young and aged murine hematopoietic stem cells revealed by quantitative clonal analysis using cellular barcoding. Blood. 2013 Jul 25;122(4):523-32. doi: 10.1182/blood-2013-01-481135. Epub 2013 May 29.'}, {'pmid': '8782459', 'type': 'BACKGROUND', 'citation': 'Morrison SJ, Wandycz AM, Akashi K, Globerson A, Weissman IL. The aging of hematopoietic stem cells. Nat Med. 1996 Sep;2(9):1011-6. doi: 10.1038/nm0996-1011.'}, {'pmid': '11698278', 'type': 'BACKGROUND', 'citation': 'Geiger H, True JM, de Haan G, Van Zant G. Age- and stage-specific regulation patterns in the hematopoietic stem cell hierarchy. Blood. 2001 Nov 15;98(10):2966-72. doi: 10.1182/blood.v98.10.2966.'}, {'pmid': '23023126', 'type': 'BACKGROUND', 'citation': 'Chakkalakal JV, Jones KM, Basson MA, Brack AS. The aged niche disrupts muscle stem cell quiescence. Nature. 2012 Oct 18;490(7420):355-60. doi: 10.1038/nature11438. Epub 2012 Sep 26.'}, {'pmid': '34696981', 'type': 'BACKGROUND', 'citation': 'Araujo AB, Salton GD, Angeli MH, Furlan JM, Schmalfuss T, Rohsig LM. Effects of cell concentration, time of fresh storage, and cryopreservation on peripheral blood stem cells: PBSC fresh storage and cryopreservation. Transfus Apher Sci. 2022 Feb;61(1):103298. doi: 10.1016/j.transci.2021.103298. Epub 2021 Oct 21.'}, {'pmid': '33865804', 'type': 'BACKGROUND', 'citation': 'Hsu JW, Farhadfar N, Murthy H, Logan BR, Bo-Subait S, Frey N, Goldstein SC, Horowitz MM, Lazarus H, Schwanke JD, Shah NN, Spellman SR, Switzer GE, Devine SM, Shaw BE, Wingard JR. The Effect of Donor Graft Cryopreservation on Allogeneic Hematopoietic Cell Transplantation Outcomes: A Center for International Blood and Marrow Transplant Research Analysis. Implications during the COVID-19 Pandemic. Transplant Cell Ther. 2021 Jun;27(6):507-516. doi: 10.1016/j.jtct.2021.03.015. Epub 2021 Mar 22.'}, {'pmid': '32547684', 'type': 'BACKGROUND', 'citation': 'Underwood J, Rahim M, West C, Britton R, Skipworth E, Graves V, Sexton S, Harris H, Schwering D, Sinn A, Pollok KE, Robertson KA, Goebel WS, Hege KM. How old is too old? In vivo engraftment of human peripheral blood stem cells cryopreserved for up to 18 years - implications for clinical transplantation and stability programs. World J Stem Cells. 2020 May 26;12(5):359-367. doi: 10.4252/wjsc.v12.i5.359.'}, {'pmid': '28650454', 'type': 'BACKGROUND', 'citation': "Pavlu J, Auner HW, Szydlo RM, Sevillano B, Palani R, O'Boyle F, Chaidos A, Jakob C, Kanfer E, MacDonald D, Milojkovic D, Rahemtulla A, Bradshaw A, Olavarria E, Apperley JF, Pello OM. Analysis of hematopoietic recovery after autologous transplantation as method of quality control for long-term progenitor cell cryopreservation. Bone Marrow Transplant. 2017 Dec;52(12):1599-1601. doi: 10.1038/bmt.2017.113. Epub 2017 Jun 26."}, {'pmid': '19392777', 'type': 'BACKGROUND', 'citation': 'Liseth K, Ersvaer E, Abrahamsen JF, Nesthus I, Ryningen A, Bruserud O. Long-term cryopreservation of autologous stem cell grafts: a clinical and experimental study of hematopoietic and immunocompetent cells. Transfusion. 2009 Aug;49(8):1709-19. doi: 10.1111/j.1537-2995.2009.02180.x.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to observe stored stem cells and determine their capability to grow based on several factors. The main two factors focused on in this study are as follows:\n\n* Time stem cells have spent in cryopreservation\n* Demographic factors (gender, race, age)', 'detailedDescription': "This study is a secondary, correlational, single-center laboratory study involving the analysis of previously obtained PBSC samples at the Andrews Research \\& Education Foundation (AREF). Individuals who previously provided samples for a primary study that has a concluded will be reconsented for this study. No manipulation of samples will occur until Broad Informed Consent has been obtained. Upon Broad Informed Consent being granted, the samples will be removed from cryopreservation and analyzed in a laboratory setting.\n\nEach sample's total nucleated cell count (TNC), cell viability, and proliferative potential will be analyzed. Measurements will be performed at different time intervals and the results will be recorded in a password protected system.\n\nThese parameters will be followed for each available PBSC sample regardless of time spent in cryopreservation to examine if variation in time spent under cryopreservation had an impact on overall cell viability and proliferative potential.\n\nFollowing conclusion of the cell viability data acquisition stage of the study, the data will be further analyzed to determine if there are any statistically relevant correlations between various demographic factors and the viabilities of the PBSC samples. The secondary, demographic factors to be examined include the sample patient's age, sex, and race. The data analysis will determine whether these factors in addition to length of time spent under cryopreservation influenced the PBSC samples' viability and proliferative potential upon the samples being removed from cryopreservation and prepared for analysis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The target study population for this study is patients of any gender (age 18 or above) that has already completed a study at Andrews Research \\& Education Foundation and has cryopreserved blood samples at the Andrews Research \\& Education Foundation Regenerative Medicine Center (RMC)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Prior primary study at Andrews Research \\& Education Foundation must be completed\n* Additional biospecimens continue to be in a cryopreserved state at Andrews Research \\& Education Foundation Regenerative Medicine Center (RMC)\n* Subject is willing and able to provide Broad Informed Consent for secondary study\n\nExclusion Criteria:\n\n* Subjects whose biospecimens did not maintain primary study sample labels\n* Subject is not willing and able to provide Broad Informed Consent for secondary study'}, 'identificationModule': {'nctId': 'NCT05573412', 'briefTitle': 'Comparison of Proliferative Potential of H-PBSC Based on Demographics and Cryopreservation Time', 'organization': {'class': 'OTHER', 'fullName': 'Andrews Research & Education Foundation'}, 'officialTitle': 'Comparison of the Proliferative Potential of Human Peripheral Blood Stem Cells Based on Demographic Factors and Cryopreservation Time', 'orgStudyIdInfo': {'id': 'PBSC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All Particpants', 'description': 'Group contains all participants as this is a systemic review of stem cell cryopreservation techniques', 'interventionNames': ['Other: Cellular analysis']}], 'interventions': [{'name': 'Cellular analysis', 'type': 'OTHER', 'description': 'Previously cryopreserved samples will be analyzed for total nucleated cell count (TNC), cell viability and proliferative potential', 'armGroupLabels': ['All Particpants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32561', 'city': 'Gulf Breeze', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica Truett, BCBA', 'role': 'CONTACT', 'email': 'Jessica.truett@andrewsref.org', 'phone': '850-916-8570'}, {'name': 'James Andrews, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Roger Ostrander, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': "Christopher O'Grady, MD", 'role': 'SUB_INVESTIGATOR'}, {'name': 'Charles Roth, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Adam Anz, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Steve Jordan, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Andrews Research & Education Foundation', 'geoPoint': {'lat': 30.35714, 'lon': -87.16386}}], 'centralContacts': [{'name': 'Jessi Truett', 'role': 'CONTACT', 'email': 'jessica.truett@andrewsref.org', 'phone': '8509168570'}, {'name': 'Joshua Cook, BS', 'role': 'CONTACT', 'email': 'joshua.cook@andrewsref.org', 'phone': '8509168590'}], 'overallOfficials': [{'name': 'Adam Anz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orthopedic Surgeon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Andrews Research & Education Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Florida', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}