Orthobiological Therapies in Musculoskeletal Disorders (PROREGEN)

February 19, 2026 updated by: PROREGEN

Clinical and Functional Evaluation of Orthobiological Therapies in Musculoskeletal Conditions

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Use of orthobiological products in musculoskeletal conditions.
After an evaluation by a medical professional, the patient will be advised on the best orthobiological treatment for their case.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
From registration until six months, one year, and two years. Two years is the final follow-up period.
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

  1. = mild pain
  2. = moderate pain
  3. = severe pain
  4. = extreme pain

Total score for the pain subscale:

0 to 20 points
Assessment at six months, one year, and two years. The total follow-up period is two years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PROREGEN

Collaborators

Centro Universitário Univates

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 30, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

January 28, 2026

First Submitted That Met QC Criteria

February 19, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8.064.745
  • Own financing (Other Identifier: PROREGEN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We cannot yet provide this information, as the study involves a larger team.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Musculoskeletal Diseases or Conditions

Clinical Trials on PRP injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe