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AzTrials

Musculoskeletal System DiseaseNCT04711551

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

An observational study of Musculoskeletal System Disease, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 2 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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… Read more about this study

Who is it for?
Ages 6 years and older
Conditions the study is for
Musculoskeletal System Disease
What is being tested?
PRP and related devices to abtain platelet concentrate from whole blood, medullary and adipose tissue and related devices
How many people
2,000 participants
Where
2 sitesItaly
Study dates
30 May 2018to 30 May 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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;

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Laura De Girolamo contact

0039 0283502221

laura.degirolamo@grupposandonato.it

Italy2 sites, 2 recruiting

  • Istituto Clinico San Siro (satellite center)

    Milan, Italia, 20100

    Claudio Legnani

    Recruiting

  • IRCCS Ospedale Galeazzi-Sant'Ambrogio (coordinator)

    Milan, Italy, 20157

    Laura De Girolamo, 0039 0283502221, laura.degirolamo@grupposandonato.it

    Recruiting

Other trials in Italy

About this study

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

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.

Being tested
PRP and related devices to abtain platelet concentrate from whole blood, medullary and adipose tissue and related devices
Medical subject headings
Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Change between baseline and 12 months

Secondary outcomes (13)

  1. 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

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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).

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

  8. 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).

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

  9. 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).

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

  10. 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).

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

  11. 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

    Measured: Baseline only

  12. 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

    Measured: Baseline only

  13. 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.

    Measured: Changes between baseline and 2-, 6- and 24-month assessments

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2021
  2. Study start30 May 2018
  3. Primary completion30 May 2030 (estimated)
  4. Study completion30 May 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04711551
Sponsor's protocol ID
REGAIN
Status last verified
Feb 2025
First submitted
23 Dec 2020
Last updated
17 Feb 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 27588219

  • 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.

    PubMed 28831830

  • 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.

    PubMed 25276781

Questions about this trial

What is this clinical trial studying?

An observational study of Musculoskeletal System Disease, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Laura De Girolamo (0039 0283502221, laura.degirolamo@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Visual Analog Scale (time frame: Change between baseline and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04711551, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.

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