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

Musculoskeletal System Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04711551
• Other study ID #: REGAIN
• Status: Recruiting
• Start date: May 30, 2018
• Est. completion date: May 30, 2030

Study information

• Verified date: December 2020
• Source: Istituto Ortopedico Galeazzi
• Contact: Laura De Girolamo
• Phone: 0039 0266214059
• Email: laura.degirolamo[@]grupposandonato.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2400
• Est. completion date: May 30, 2030
• Est. primary completion date: May 30, 2030
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Musculoskeletal System Disease

Intervention

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

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Galeazzi	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

Kern S, Eichler H, Stoeve J, Klüter 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. Epub 2006 Jan 12. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Visual Analog Scale	Pain will be measured with Visual Analog Scale (0-10, where 0 rapresents absence of pain and 10 the maximum pain possible) before and after treatment.	Change between baseline and 12 months
Secondary	Change in Tegner Activity Scale	Level of activity will be recorded using Tegner activity scale (0-10, where 0 represents absence of physical activity and 10 represents national level sport activity) before and after treatment	Changes between baseline and 2-, 6- 12 and 24-month assessments
Secondary	Change in Knee injury and Osteoarthritis Outcome Score for patients affected by knee osteoarthritis	The level of symptoms, pain, activity, sport and quality of life will be assessed using Knee injury and Osteoarthritis Outcome Score (0-100, where 0 represents the worst outcome and 100 the best outcome) before and after treatment.	Changes between baseline and 2-, 6- 12 and 24-month assessments
Secondary	Change in Hip injury and Osteoarthritis Outcome Score for patients affected by hip osteoarthritis	The level of symptoms, pain, activity, sport and quality of life will be assessed using Hip injury and Osteoarthritis Outcome Score (0-100, where 0 represents the worst condition and 100 the best condition) before and after treatment.	Changes between baseline and 2-, 6- 12 and 24-month assessments
Secondary	Change in QuickDASH (Disabilities of the Arm, Shoulder and Hand) and SPADI (Shoulder Pain and Disability Index ) questionnaire for patients affected by shoulder disorders	The level of symptoms, pain, activity, sport and quality of life will be assessed using Hip injury and Osteoarthritis Outcome Score (0-100, where 0 represents the worst condition and 100 the best condition) before and after treatment.	Changes between baseline and 2-, 6- 12 and 24-month assessments
Secondary	Change in the Shoulder Pain and Disability Index (SPADI) for patients affected by shoulder disorders	Pain level and extent of difficulty with the activity of daily living will be assessed using SPADI (0-100, where 100 represents the worst condition and 0 the best condition) in patients affected by shoulder disorders.	Changes between baseline and 2-, 6- 12 and 24-month assessments
Secondary	Change in Victorian Institute of Sport Assessment for Patellar tendon (VISA-P) score for patients affected by patellar tendon disorders	Symptoms, ability to perform daily and sport activities will be measured using VISA-P score (0-100, where 0 represents the worst condition and 100 the best condition) in patients affected by patellar tendon disorders.	Changes between baseline and 2-, 6- 12 and 24-month assessments
Secondary	Change in Lysholm Knee Score for patients affected by patellar tendon disorders	Lysholm knee score will be used to assess the condition of the knee in patients affected by patellar tendon disorders (0-100, where 0 represents the worst condition and 100 the best condition).	Changes between baseline and 2-, 6- 12 and 24-month assessments
Secondary	Change in Foot Function Index (FFI) for patients affected by ankle and foot disorders	Pain, Disability, and Activity Limitation in patients affected by foot and ankle disorders will be measured using FFI (0-100, where 100 represents the worst condition and 0 the best condition).	Changes between baseline and 2-, 6- 12 and 24-month assessments
Secondary	Change in Victorian Institute of Sport Assessment for Achilles tendon (VISA-A) score for patients affected by Achilles tendon disorders	Symptoms, ability to perform daily and sport activities will be measured in patients affected by Achilles tendon disorders using VISA-A score (0-100, where 0 represents the worst condition and 100 the best condition).	Changes between baseline and 2-, 6- 12 and 24-month assessments
Secondary	Change in Patient-Rated Tennis Elbow Evaluation (PRTEE) scale for patients affected by elbow disorders	Pain and function will be measured in patients affected by elbow disorders using PRTEE score (0-100, where 100 represents the worst condition and 0 the best condition).	Changes between baseline and 2-, 6- 12 and 24-month assessments
Secondary	Platelet count in Platelet-rich Plasma (PRP)	For each patient receiving PRP, platelet count will be measured in order to evaluate possible correlation between the product composition and the clinical outcomes	Baseline only
Secondary	Nucleated cell counts in adipose tissue- and bone marrow-derived orthobiologics	For each patient receiving adipose tissue- or bone marrow-derived orthobiologics, the number of nucleated cells will be determined to evaluate possible correlation between the product composition and the clinical outcomes	Baseline only
Secondary	Change in Visual Analog Scale	Pain will be measured with Visual Analog Scale (0-10, where 0 rapresents absence of pain and 10 the maximum pain possible) before and after treatment.	Changes between baseline and 2-, 6- and 24-month assessments