Comparison of Proliferative Potential of H-PBSC Based on Demographics and Cryopreservation Time

NCT05573412 | Unknown

• 1 other identifier: PBSC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• Time stem cells have spent in cryopreservation
• Demographic factors (gender, race, age)

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Beckman-Coulter Flow Cytometer

  Machine that provides a digital view of cells that are categorized utilizing laser light to differentiate cell types while samples are suspended in a fast-flowing liquid; will be utilized to determine proliferative potential, total nucleated cell count, and cell viability of each cryopreserved sample

  At enrollment

Study Arms (1)

All Particpants

Group contains all participants as this is a systemic review of stem cell cryopreservation techniques

Other: Cellular analysis

Interventions

Cellular analysis OTHER

Previously cryopreserved samples will be analyzed for total nucleated cell count (TNC), cell viability and proliferative potential

All Particpants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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)

You may qualify if:

• years of age or older
• Prior primary study at Andrews Research \& Education Foundation must be completed
• Additional biospecimens continue to be in a cryopreserved state at Andrews Research \& Education Foundation Regenerative Medicine Center (RMC)
• Subject is willing and able to provide Broad Informed Consent for secondary study

You may not qualify if:

• Subjects whose biospecimens did not maintain primary study sample labels
• Subject is not willing and able to provide Broad Informed Consent for secondary study

Sponsors & Collaborators

• Andrews Research & Education Foundation: lead
• Florida: collaborator

Study Sites (1)

Andrews Research & Education Foundation

Gulf Breeze, Florida, 32561, United States

RECRUITING

Related Publications (38)

• Gratwohl A, Hermans J, Baldomero H. Hematopoietic precursor cell transplants in Europe: activity in 1994. Report from the European Group for Blood and Marrow Transplantation (EBMT). Bone Marrow Transplant. 1996 Feb;17(2):137-48.

  PMID: 8640158 BACKGROUND

• Korbling M, Freireich EJ. Twenty-five years of peripheral blood stem cell transplantation. Blood. 2011 Jun 16;117(24):6411-6. doi: 10.1182/blood-2010-12-322214. Epub 2011 Apr 1.

  PMID: 21460243 BACKGROUND

• Schmitz N, Bacigalupo A, Hasenclever D, Nagler A, Gluckman E, Clark P, Bourquelot P, Greinix H, Frickhofen N, Ringden O, Zander A, Apperley JF, Gorin C, Borkett K, Schwab G, Goebel M, Russell NH, Gratwohl A. Allogeneic bone marrow transplantation vs filgrastim-mobilised peripheral blood progenitor cell transplantation in patients with early leukaemia: first results of a randomised multicentre trial of the European Group for Blood and Marrow Transplantation. Bone Marrow Transplant. 1998 May;21(10):995-1003. doi: 10.1038/sj.bmt.1701234.

  PMID: 9632272 BACKGROUND

• Blaise D, Kuentz M, Fortanier C, Bourhis JH, Milpied N, Sutton L, Jouet JP, Attal M, Bordigoni P, Cahn JY, Boiron JM, Schuller MP, Moatti JP, Michallet M. Randomized trial of bone marrow versus lenograstim-primed blood cell allogeneic transplantation in patients with early-stage leukemia: a report from the Societe Francaise de Greffe de Moelle. J Clin Oncol. 2000 Feb;18(3):537-46. doi: 10.1200/JCO.2000.18.3.537.

  PMID: 10653869 BACKGROUND

• Cutler C, Antin JH. Peripheral blood stem cells for allogeneic transplantation: a review. Stem Cells. 2001;19(2):108-17. doi: 10.1634/stemcells.19-2-108.

  PMID: 11239165 BACKGROUND

• Nehrer S, Spector M, Minas T. Histologic analysis of tissue after failed cartilage repair procedures. Clin Orthop Relat Res. 1999 Aug;(365):149-62. doi: 10.1097/00003086-199908000-00020.

  PMID: 10627699 BACKGROUND

• Mithoefer K, Williams RJ 3rd, Warren RF, Potter HG, Spock CR, Jones EC, Wickiewicz TL, Marx RG. The microfracture technique for the treatment of articular cartilage lesions in the knee. A prospective cohort study. J Bone Joint Surg Am. 2005 Sep;87(9):1911-20. doi: 10.2106/JBJS.D.02846.

  PMID: 16140804 BACKGROUND

• Minas T, Ogura T, Bryant T. Autologous Chondrocyte Implantation. JBJS Essent Surg Tech. 2016 Jun 22;6(2):e24. doi: 10.2106/JBJS.ST.16.00018. eCollection 2016 Jun 22.

  PMID: 30237933 BACKGROUND

• Fortier LA, Potter HG, Rickey EJ, Schnabel LV, Foo LF, Chong LR, Stokol T, Cheetham J, Nixon AJ. Concentrated bone marrow aspirate improves full-thickness cartilage repair compared with microfracture in the equine model. J Bone Joint Surg Am. 2010 Aug 18;92(10):1927-37. doi: 10.2106/JBJS.I.01284.

  PMID: 20720135 BACKGROUND

• Lee KB, Hui JH, Song IC, Ardany L, Lee EH. Injectable mesenchymal stem cell therapy for large cartilage defects--a porcine model. Stem Cells. 2007 Nov;25(11):2964-71. doi: 10.1634/stemcells.2006-0311. Epub 2007 Jul 26.

  PMID: 17656639 BACKGROUND

• McIlwraith CW, Frisbie DD, Rodkey WG, Kisiday JD, Werpy NM, Kawcak CE, Steadman JR. Evaluation of intra-articular mesenchymal stem cells to augment healing of microfractured chondral defects. Arthroscopy. 2011 Nov;27(11):1552-61. doi: 10.1016/j.arthro.2011.06.002. Epub 2011 Aug 20.

  PMID: 21862278 BACKGROUND

• Nejadnik H, Hui JH, Feng Choong EP, Tai BC, Lee EH. Autologous bone marrow-derived mesenchymal stem cells versus autologous chondrocyte implantation: an observational cohort study. Am J Sports Med. 2010 Jun;38(6):1110-6. doi: 10.1177/0363546509359067. Epub 2010 Apr 14.

  PMID: 20392971 BACKGROUND

• Tay LX, Ahmad RE, Dashtdar H, Tay KW, Masjuddin T, Ab-Rahim S, Chong PP, Selvaratnam L, Kamarul T. Treatment outcomes of alginate-embedded allogenic mesenchymal stem cells versus autologous chondrocytes for the repair of focal articular cartilage defects in a rabbit model. Am J Sports Med. 2012 Jan;40(1):83-90. doi: 10.1177/0363546511420819. Epub 2011 Sep 13.

  PMID: 21917609 BACKGROUND

• Wakitani S, Goto T, Pineda SJ, Young RG, Mansour JM, Caplan AI, Goldberg VM. Mesenchymal cell-based repair of large, full-thickness defects of articular cartilage. J Bone Joint Surg Am. 1994 Apr;76(4):579-92. doi: 10.2106/00004623-199404000-00013.

  PMID: 8150826 BACKGROUND

• Saw KY, Hussin P, Loke SC, Azam M, Chen HC, Tay YG, Low S, Wallin KL, Ragavanaidu K. Articular cartilage regeneration with autologous marrow aspirate and hyaluronic Acid: an experimental study in a goat model. Arthroscopy. 2009 Dec;25(12):1391-400. doi: 10.1016/j.arthro.2009.07.011. Epub 2009 Sep 17.

  PMID: 19962065 BACKGROUND

• Saw KY, Anz A, Merican S, Tay YG, Ragavanaidu K, Jee CS, McGuire DA. Articular cartilage regeneration with autologous peripheral blood progenitor cells and hyaluronic acid after arthroscopic subchondral drilling: a report of 5 cases with histology. Arthroscopy. 2011 Apr;27(4):493-506. doi: 10.1016/j.arthro.2010.11.054. Epub 2011 Feb 19.

  PMID: 21334844 BACKGROUND

• Saw KY, Anz A, Siew-Yoke Jee C, Merican S, Ching-Soong Ng R, Roohi SA, Ragavanaidu K. Articular cartilage regeneration with autologous peripheral blood stem cells versus hyaluronic acid: a randomized controlled trial. Arthroscopy. 2013 Apr;29(4):684-94. doi: 10.1016/j.arthro.2012.12.008. Epub 2013 Feb 4.

  PMID: 23380230 BACKGROUND

• 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: 34265388 BACKGROUND

• 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: 3264199 BACKGROUND

• Matsunaga T, Sakamaki S, Kohgo Y, Ohi S, Hirayama Y, Niitsu Y. Recombinant human granulocyte colony-stimulating factor can mobilize sufficient amounts of peripheral blood stem cells in healthy volunteers for allogeneic transplantation. Bone Marrow Transplant. 1993 Feb;11(2):103-8.

  PMID: 7679596 BACKGROUND

• Lane TA, Law P, Maruyama M, Young D, Burgess J, Mullen M, Mealiffe M, Terstappen LW, Hardwick A, Moubayed M, et al. Harvesting and enrichment of hematopoietic progenitor cells mobilized into the peripheral blood of normal donors by granulocyte-macrophage colony-stimulating factor (GM-CSF) or G-CSF: potential role in allogeneic marrow transplantation. Blood. 1995 Jan 1;85(1):275-82.

  PMID: 7528570 BACKGROUND

• Skulimowska I, Sosniak J, Gonka M, Szade A, Jozkowicz A, Szade K. The biology of hematopoietic stem cells and its clinical implications. FEBS J. 2022 Dec;289(24):7740-7759. doi: 10.1111/febs.16192. Epub 2021 Sep 29.

  PMID: 34496144 BACKGROUND

• Granick JL, Simon SI, Borjesson DL. Hematopoietic stem and progenitor cells as effectors in innate immunity. Bone Marrow Res. 2012;2012:165107. doi: 10.1155/2012/165107. Epub 2012 Jun 19.

  PMID: 22762001 BACKGROUND

• Oh J, Lee YD, Wagers AJ. Stem cell aging: mechanisms, regulators and therapeutic opportunities. Nat Med. 2014 Aug;20(8):870-80. doi: 10.1038/nm.3651.

  PMID: 25100532 BACKGROUND

• Ahmed AS, Sheng MH, Wasnik S, Baylink DJ, Lau KW. Effect of aging on stem cells. World J Exp Med. 2017 Feb 20;7(1):1-10. doi: 10.5493/wjem.v7.i1.1. eCollection 2017 Feb 20.

  PMID: 28261550 BACKGROUND

• Schultz MB, Sinclair DA. When stem cells grow old: phenotypes and mechanisms of stem cell aging. Development. 2016 Jan 1;143(1):3-14. doi: 10.1242/dev.130633.

  PMID: 26732838 BACKGROUND

• Boyette LB, Tuan RS. Adult Stem Cells and Diseases of Aging. J Clin Med. 2014 Jan 21;3(1):88-134. doi: 10.3390/jcm3010088.

  PMID: 24757526 BACKGROUND

• Rossi DJ, Bryder D, Zahn JM, Ahlenius H, Sonu R, Wagers AJ, Weissman IL. Cell intrinsic alterations underlie hematopoietic stem cell aging. Proc Natl Acad Sci U S A. 2005 Jun 28;102(26):9194-9. doi: 10.1073/pnas.0503280102. Epub 2005 Jun 20.

  PMID: 15967997 BACKGROUND

• Sudo K, Ema H, Morita Y, Nakauchi H. Age-associated characteristics of murine hematopoietic stem cells. J Exp Med. 2000 Nov 6;192(9):1273-80. doi: 10.1084/jem.192.9.1273.

  PMID: 11067876 BACKGROUND

• Verovskaya E, Broekhuis MJ, Zwart E, Ritsema M, van Os R, de Haan G, Bystrykh LV. 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: 23719303 BACKGROUND

• 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: 8782459 BACKGROUND

• 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: 11698278 BACKGROUND

• 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: 23023126 BACKGROUND

• 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: 34696981 BACKGROUND

• 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: 33865804 BACKGROUND

• 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: 32547684 BACKGROUND

• 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: 28650454 BACKGROUND

• 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.

  PMID: 19392777 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood stem cells previously preserved in cryostorage

Study Officials

• Adam Anz, MD

  Orthopedic Surgeon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessi Truett

CONTACT

8509168570; jessica.truett@andrewsref.org

Joshua Cook, BS

CONTACT

8509168590; joshua.cook@andrewsref.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 10, 2022
• Study Start: August 16, 2022
• Primary Completion: August 16, 2023
• Study Completion: August 16, 2023
• Last Updated: October 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)