NCT07434115

Orthobiological Therapies in Musculoskeletal Disorders

Clinical and Functional Evaluation of Orthobiological Therapies in Musculoskeletal Conditions

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: PROREGEN · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the clinical and functional effects of using orthobiological therapies (hyaluronic acid, platelet-rich plasma, bone marrow aspirate, nanofat, among others) in the treatment of various musculoskeletal diseases in patients routinely treated at the Proregen Medical Clinic and its affiliates. The sample will consist of adult patients (≥18 years), of both sexes, with different musculoskeletal diagnoses involving joints, tendons, ligaments, cartilage or bone, among others.

Detailed description

Orthobiological therapies, such as hyaluronic acid, platelet-rich plasma, bone marrow aspirate concentrate, and adipose tissue derivatives, have been widely used in the management of musculoskeletal pathologies, including tendinopathies, osteoarthritis, and delayed bone consolidation. However, scientific evidence is still limited by the heterogeneity of protocols, populations, and evaluation methods. This umbrella project aims to prospectively record and analyze the clinical and functional outcomes associated with the use of these therapies in patients treated according to institutional medical indications. Participants with different osteoarticular pathologies undergoing routine orthobiological treatment at the Proregen Medical Clinic and its affiliates will be included. The central hypotheses of the study are that orthobiological therapies present measurable clinical benefits in terms of pain, function, and quality of life in various osteoarticular indications; that the safety of these approaches is adequate when performed under defined clinical criteria; and that it is possible to identify patterns of greater efficacy according to the type of orthobiological agent, the pathology, and the follow-up time. As an expected conclusion, the study aims to generate real clinical data that can serve as a basis for derivative studies, in addition to contributing to the standardization and rationalization of the use of orthobiological therapies in orthopedic practice.

Conditions

• Musculoskeletal Diseases or Conditions

Interventions

Type	Name	Description
BIOLOGICAL	PRP injection	Obtained by centrifuging blood, it concentrates platelets and growth factors for regeneration.
BIOLOGICAL	Bone Marrow Concentrate (BMAC)	Bone marrow aspirate, rich in mesenchymal stem cells and progenitor cells for tissue repair.
BIOLOGICAL	Hyaluronic Acid (Viscosupplementation)	Used for joint lubrication and cartilage protection, very common in osteoarthritis.
BIOLOGICAL	Nanofat	It is an even more refined and liquefied form of processed fat, used primarily for high-precision tissue repair.

Timeline

• Start date: 2026-01-30
• Primary completion: 2029-01-01
• Completion: 2030-01-01
• First posted: 2026-02-25
• Last updated: 2026-02-25