Clinical and Biomolecular Assessment for the Monitoring of Patients Undergoing Regenerative Medicine Treatments with Orthobiologics
NCT ID: NCT04711551
Last Updated: 2025-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2000 participants
OBSERVATIONAL
2018-05-30
2030-05-30
Brief Summary
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patients who undergo regenerative medicine treatments present acute and chronic pathologies of the musculoskeletal system, of the stomatological system and of the integuments.
Objective pre, peri and post treatment evaluations are collected. A dedicated software collects the PROMs compiled by the patients, the objective clinical data and the biomolecular evaluations.
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Interventions
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PRP and related devices to abtain platelet concentrate from whole blood, medullary and adipose tissue and related devices
PRP and related devices to abtain platelet concentrate from whole blood, medullary and adipose tissue and related devices
Eligibility Criteria
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Inclusion Criteria
* males and females;
* age \>= 6 years.
Exclusion Criteria
* patients not compliant with post-treatment monitoring procedures
* pregnancy
6 Years
ALL
No
Sponsors
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I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
OTHER
Responsible Party
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Principal Investigators
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Laura De Girolamo
Role: PRINCIPAL_INVESTIGATOR
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Locations
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Istituto Clinico San Siro (satellite center)
Milan, Italia, Italy
IRCCS Ospedale Galeazzi-Sant'Ambrogio (coordinator)
Milan, Italy, Italy
Countries
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Central Contacts
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Facility Contacts
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Claudio Legnani
Role: primary
References
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Mazzocca AD, McCarthy MB, Chowaniec DM, Dugdale EM, Hansen D, Cote MP, Bradley JP, Romeo AA, Arciero RA, Beitzel K. The positive effects of different platelet-rich plasma methods on human muscle, bone, and tendon cells. Am J Sports Med. 2012 Aug;40(8):1742-9. doi: 10.1177/0363546512452713. Epub 2012 Jul 16.
Smith PA. Intra-articular Autologous Conditioned Plasma Injections Provide Safe and Efficacious Treatment for Knee Osteoarthritis: An FDA-Sanctioned, Randomized, Double-blind, Placebo-controlled Clinical Trial. Am J Sports Med. 2016 Apr;44(4):884-91. doi: 10.1177/0363546515624678. Epub 2016 Feb 1.
Kern S, Eichler H, Stoeve J, Kluter H, Bieback K. Comparative analysis of mesenchymal stem cells from bone marrow, umbilical cord blood, or adipose tissue. Stem Cells. 2006 May;24(5):1294-301. doi: 10.1634/stemcells.2005-0342. Epub 2006 Jan 12.
Strioga M, Viswanathan S, Darinskas A, Slaby O, Michalek J. Same or not the same? Comparison of adipose tissue-derived versus bone marrow-derived mesenchymal stem and stromal cells. Stem Cells Dev. 2012 Sep 20;21(14):2724-52. doi: 10.1089/scd.2011.0722. Epub 2012 May 9.
Vishnubalaji R, Al-Nbaheen M, Kadalmani B, Aldahmash A, Ramesh T. Comparative investigation of the differentiation capability of bone-marrow- and adipose-derived mesenchymal stem cells by qualitative and quantitative analysis. Cell Tissue Res. 2012 Feb;347(2):419-27. doi: 10.1007/s00441-011-1306-3.
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.
Bosetti M, Borrone A, Follenzi A, Messaggio F, Tremolada C, Cannas M. Human Lipoaspirate as Autologous Injectable Active Scaffold for One-Step Repair of Cartilage Defects. Cell Transplant. 2016;25(6):1043-56. doi: 10.3727/096368915X689514. Epub 2015 Sep 21.
Pak J, Lee JH, Park KS, Jeong BC, Lee SH. Regeneration of Cartilage in Human Knee Osteoarthritis with Autologous Adipose Tissue-Derived Stem Cells and Autologous Extracellular Matrix. Biores Open Access. 2016 Aug 1;5(1):192-200. doi: 10.1089/biores.2016.0024. eCollection 2016.
Moatshe G, Morris ER, Cinque ME, Pascual-Garrido C, Chahla J, Engebretsen L, Laprade RF. Biological treatment of the knee with platelet-rich plasma or bone marrow aspirate concentrates. Acta Orthop. 2017 Dec;88(6):670-674. doi: 10.1080/17453674.2017.1368899. Epub 2017 Aug 23.
Centeno C, Pitts J, Al-Sayegh H, Freeman M. Efficacy of autologous bone marrow concentrate for knee osteoarthritis with and without adipose graft. Biomed Res Int. 2014;2014:370621. doi: 10.1155/2014/370621. Epub 2014 Sep 7.
Other Identifiers
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REGAIN
Identifier Type: -
Identifier Source: org_study_id
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