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NCT Number: NCT07434115

Orthobiological Therapies in Musculoskeletal Disorders

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 or older;
  • Clinical and/or radiological diagnosis of an eligible musculoskeletal condition;
  • Formal clinical indication for treatment with orthobiological agents, according to routine care;
  • Regular access to the WhatsApp application, ensuring the necessary communication for sending and receiving digital questionnaires and other study instructions;
  • Ability to understand the study and sign the Informed Consent Form.

Exclusion criteria

  • Medical contraindication to the use of orthobiologics (e.g., active infection, severe hematological diseases, active cancer);
  • Recent use (≤3 months) of orthobiologic therapies in the same area to be treated;
  • Pregnant or breastfeeding women;
  • Cognitive or psychiatric diseases that prevent adequate clinical follow-up;
  • Simultaneous participation in another interventional clinical study with the same therapeutic purpose.

Treatment and study plan

PRP injection

Biological

Obtained by centrifuging blood, it concentrates platelets and growth factors for regeneration.

Bone Marrow Concentrate (BMAC)

Biological

Bone marrow aspirate, rich in mesenchymal stem cells and progenitor cells for tissue repair.

Hyaluronic Acid (Viscosupplementation)

Biological

Used for joint lubrication and cartilage protection, very common in osteoarthritis.

nanofat

Biological

It is an even more refined and liquefied form of processed fat, used primarily for high-precision tissue repair.

Primary outcomes

  1. Pain scale

    Time frame: From registration until six months, one year, and two years. Two years is the final follow-up period.

    Changes in pain scores six months after treatment with orthobiological materials.

    The following scale will be used:

    VAS - Visual Analog Scale (0 to 10 cm): The patient marks, with a line or dot, the location on the line that best represents the pain they are feeling at that moment. 0 cm → "no pain" / 10 cm → "worst pain imaginable".

  2. Joint function

    Time frame: Assessment at six months, one year, and two years. The total follow-up period is two years.

    Changes observed in joint function in patients who received orthobiological treatment after 6 months. The following scales will be used:

    WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index): is a questionnaire specific to osteoarthritis, widely validated and used in clinical research. It assesses symptoms and functional impact of osteoarthritis. The WOMAC consists of 24 items, divided into 3 subscales:

    Pain - 5 items Stiffness - 2 items Physical function - 17 items

    Scoring is as follows:

    0 = no pain

    • = mild pain
    • = moderate pain
    • = severe pain
    • = extreme pain

    Total score for the pain subscale:

    0 to 20 points

Sponsors and collaborators

Lead sponsor

PROREGEN

Network

Collaborators

  • Centro Universitário Univates

Registry information

Official study title

Clinical and Functional Evaluation of Orthobiological Therapies in Musculoskeletal Conditions

Acronym: PROREGEN

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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