Monitoring patients receiving regenerative medicine treatments for musculoskeletal diseases
Official title: Patients-reported Outcome Measures (PROMs), Clinical Objective and Biomolecular Assessment for the Monitoring of Patients Undergoing Regenerative Medicine Treatments with Orthobiologics
Run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · NCT04711551 · Data updated 2026-11-12
This study is testing how well regenerative medicine treatments, like platelet-rich plasma, work for people with musculoskeletal diseases by collecting and tracking their health data before, during, and after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 6 Years and up |
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio Academic / other |
| Locations | 2 sites (Milan, Italia and 1 other locations) |
| Status | Recruiting |
| Started | May 30, 2018 |
| Main results expected | May 30, 2030 |
| Study ends | May 30, 2030 |
| Registry record updated | February 17, 2025 |
| Trial ID | NCT04711551 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients aged 6 years and older with specific musculoskeletal conditions such as osteoarthritis or tendon pain.
✕Probably not a fit
Patients under 6 years of age or those who are not compliant with post-treatment monitoring procedures may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to enhance the evaluation of outcomes for patients undergoing regenerative medicine treatments at participating centers. It focuses on collecting objective clinical data, patient-reported outcome measures (PROMs), and biomolecular evaluations before, during, and after treatment. The study utilizes advanced software to streamline data collection and analysis, ensuring comprehensive monitoring of treatment efficacy. The interventions include the use of platelet-rich plasma (PRP) and other related devices to obtain platelet concentrates from various sources.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes and personalized care for patients with musculoskeletal conditions.
How similar studies have gone: Other studies have shown promise in using similar monitoring approaches in regenerative medicine, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Istituto Clinico San Siro (satellite center)
Milan, Italia, Italy Recruiting -
IRCCS Ospedale Galeazzi-Sant'Ambrogio (coordinator)
Milan, Italy, Italy Recruiting
Study contacts
- Principal investigator: Laura De Girolamo — I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Study coordinator: Laura De Girolamo
- Email: laura.degirolamo@grupposandonato.it
- Phone: 0039 0283502221
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.