Monitoring patients receiving regenerative medicine treatments for musculoskeletal diseases
Patients-reported Outcome Measures (PROMs), Clinical Objective and Biomolecular Assessment for the Monitoring of Patients Undergoing Regenerative Medicine Treatments with Orthobiologics
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 |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 6 Years and up |
| Sex | All |
| Sponsor | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio Academic / other |
| Locations | 2 sites (Milan, Italia and 1 other locations) |
| Trial ID | NCT04711551 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients aged 6 years and older with specific musculoskeletal conditions such as osteoarthritis or tendon pain.
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.
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 performed: Other studies have shown promise in using similar monitoring approaches in regenerative medicine, indicating potential for success.
Eligibility criteria
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 this trial is running
Milan, Italia and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.