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Recruiting NCT04711551

Clinical and Biomolecular Assessment for the Monitoring of Patients Undergoing Regenerative Medicine Treatments with Orthobiologics

— Observational Musculoskeletal System Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PRP and related devices to abtain platelet concentrate from whole blood, medullary and adipose tissue and related devices.
Who it may be relevant to
Registry conditions: Musculoskeletal System Disease. Basic parameters: from 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Patients-reported Outcome Measures (PROMs), Clinical Objective and Biomolecular Assessment for the Monitoring of Patients Undergoing Regenerative Medicine Treatments with Orthobiologics

Overview

the aim is to improve the evaluation of the outcomes of regenerative medicine treatments performed in the regenerative medicine centers involved in the study. 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.

Interventions

  • Combination product 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

Primary outcome measures

  • Change in Visual Analog Scale [Time frame: Change between baseline and 12 months]
Secondary outcome measures (12)
  • Change in Tegner Activity Scale [Time frame: Changes between baseline and 2-, 6- 12 and 24-month assessments]
  • Change in Knee injury and Osteoarthritis Outcome Score for patients affected by knee osteoarthritis [Time frame: Changes between baseline and 2-, 6- 12 and 24-month assessments]
  • Change in Hip injury and Osteoarthritis Outcome Score for patients affected by hip osteoarthritis [Time frame: Changes between baseline and 2-, 6- 12 and 24-month assessments]
  • Change in QuickDASH (Disabilities of the Arm, Shoulder and Hand) and SPADI (Shoulder Pain and Disability Index ) questionnaire for patients affected by shoulder disorders [Time frame: Changes between baseline and 2-, 6- 12 and 24-month assessments]
  • Change in the Shoulder Pain and Disability Index (SPADI) for patients affected by shoulder disorders [Time frame: Changes between baseline and 2-, 6- 12 and 24-month assessments]
  • Change in Victorian Institute of Sport Assessment for Patellar tendon (VISA-P) score for patients affected by patellar tendon disorders [Time frame: Changes between baseline and 2-, 6- 12 and 24-month assessments]
  • Change in Lysholm Knee Score for patients affected by patellar tendon disorders [Time frame: Changes between baseline and 2-, 6- 12 and 24-month assessments]
  • Change in Foot Function Index (FFI) for patients affected by ankle and foot disorders [Time frame: Changes between baseline and 2-, 6- 12 and 24-month assessments]
  • Change in Victorian Institute of Sport Assessment for Achilles tendon (VISA-A) score for patients affected by Achilles tendon disorders [Time frame: Changes between baseline and 2-, 6- 12 and 24-month assessments]
  • Change in Patient-Rated Tennis Elbow Evaluation (PRTEE) scale for patients affected by elbow disorders [Time frame: Changes between baseline and 2-, 6- 12 and 24-month assessments]
  • Platelet count in Platelet-rich Plasma (PRP) [Time frame: Baseline only]
  • Nucleated cell counts in adipose tissue- and bone marrow-derived orthobiologics [Time frame: Baseline only]

Eligibility criteria

Inclusion criteria

  • patients who received indication for regerative medicine treatment for one of the following pathologies: Knee or hip or ankle osteoarthritis, patellar or Achilles tendon pain, shouder or elbow pain;
  • males and females;
  • age >= 6 years.

Exclusion criteria

  • age < 6 years
  • patients not compliant with post-treatment monitoring procedures
  • pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 2 centers
  • Istituto Clinico San Siro (satellite center) — Milan
  • IRCCS Ospedale Galeazzi-Sant'Ambrogio (coordinator) — Milan

Publications

  • 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. PMID 22802273
  • 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. PMID 26831629
  • 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. PMID 16410387
  • 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. PMID 22468918
  • 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. PMID 22287041
  • 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. PMID 21726829
  • 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. PMID 26395761
  • 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. PMID 27588219

Identifiers

NCT: NCT04711551 · REGAIN

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗