NCT04711551

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
49mo left

Started May 2018

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
May 2018May 2030

Study Start

First participant enrolled

May 30, 2018

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2030

Last Updated

February 17, 2025

Status Verified

February 1, 2025

Enrollment Period

12 years

First QC Date

December 23, 2020

Last Update Submit

February 13, 2025

Conditions

Musculoskeletal System Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Change in Tegner Activity Scale

    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

    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

    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

    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

    Changes between baseline and 2-, 6- 12 and 24-month assessments

  • +8 more secondary outcomes

Interventions

PRP and related devices to abtain platelet concentrate from whole blood, medullary and adipose tissue and related devicesCOMBINATION_PRODUCT

PRP and related devices to abtain platelet concentrate from whole blood, medullary and adipose tissue and related devices

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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;

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Istituto Clinico San Siro (satellite center)

Milan, Italia, 20100, Italy

RECRUITING

IRCCS Ospedale Galeazzi-Sant'Ambrogio (coordinator)

Milan, Italy, 20157, Italy

RECRUITING

Related Publications (10)

  • 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: 22802273BACKGROUND

  • 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: 26831629BACKGROUND

  • 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: 16410387BACKGROUND

  • 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: 22468918BACKGROUND

  • 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: 22287041BACKGROUND

  • 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: 21726829BACKGROUND

  • 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: 26395761BACKGROUND

  • 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: 27588219BACKGROUND

  • 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.

    PMID: 28831830BACKGROUND

  • 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.

    PMID: 25276781BACKGROUND

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

  • Laura De Girolamo

    I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura De Girolamo

CONTACT

0039 0283502221laura.degirolamo@grupposandonato.it

Study Design

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

Study Record Dates

First Submitted

December 23, 2020

First Posted

January 15, 2021

Study Start

May 30, 2018

Primary Completion (Estimated)

May 30, 2030

Study Completion (Estimated)

May 30, 2030

Last Updated

February 17, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)