AzTrials
AzTrials

Musculoskeletal Diseases or ConditionsEarly Phase 1PROREGENNCT07434115

Orthobiological Therapies in Musculoskeletal Disorders

A Early Phase 1 study testing PRP injection, Bone Marrow Concentrate (BMAC) and Hyaluronic Acid (Viscosupplementation) in people with Musculoskeletal Diseases or Conditions, run by PROREGEN at 1 site in Brazil.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Musculoskeletal Diseases or Conditions
What is being tested?
PRP injection, Bone Marrow Concentrate (BMAC) and Hyaluronic Acid (Viscosupplementation)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteBrazil
Study dates
16 Sep 2026to Jan 2030
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Gabriela D Daiprai contact

51995342193

gdaiprai@universo.univates.br

Brazil1 site, 1 recruiting

  • Clínica Proregen | Clínica Ortopédica em Bento | Dr. André Kruel

    Bento Gonçalves, Rio Grande do Sul, 95700-066

    Secretária responsável, 5437020302, contato@proregen.com.br

    Recruiting

Other trials in Brazil

About this study

Official title: 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.

Read the 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.

Being tested
PRP injection, Bone Marrow Concentrate (BMAC), Hyaluronic Acid (Viscosupplementation), Nanofat
Medical subject headings
Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRP injectionBiological

    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.

  • NanofatBiological

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

Study groups in NCT07434115
Study groupRoleWhat they receive
Use of orthobiological products in musculoskeletal conditions.ExperimentalAfter an evaluation by a medical professional, the patient will be advised on the best orthobiological treatment for their case.
Receives: Biological: PRP injection; Biological: Bone Marrow Concentrate (BMAC); Biological: Hyaluronic Acid (Viscosupplementation); Biological: Nanofat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain scale

    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".

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

  2. Joint function

    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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2026
  2. Study start16 Sep 2026
  3. Primary completionJan 2029 (estimated)
  4. Study completionJan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07434115
Sponsor's protocol ID
8.064.745
Other IDs
Own financing
Acronym
PROREGEN
Status last verified
Sep 2026
First submitted
28 Jan 2026
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: We cannot yet provide this information, as the study involves a larger team.

Publications

  • Winkler T, Geissler S, Maleitzke T, Perka C, Duda GN, Hildebrandt A. Advanced therapies in orthopaedics. EFORT Open Rev. 2024 Sep 2;9(9):837-844. doi: 10.1530/EOR-24-0084.

    PubMed 39222330

  • Bensa A, Previtali D, Sangiorgio A, Boffa A, Salerno M, Filardo G. PRP Injections for the Treatment of Knee Osteoarthritis: The Improvement Is Clinically Significant and Influenced by Platelet Concentration: A Meta-analysis of Randomized Controlled Trials. Am J Sports Med. 2025 Mar;53(3):745-754. doi: 10.1177/03635465241246524. Epub 2025 Jan 3.

    PubMed 39751394

  • Chu CR, Rodeo S, Bhutani N, Goodrich LR, Huard J, Irrgang J, LaPrade RF, Lattermann C, Lu Y, Mandelbaum B, Mao J, McIntyre L, Mishra A, Muschler GF, Piuzzi NS, Potter H, Spindler K, Tokish JM, Tuan R, Zaslav K, Maloney W. Optimizing Clinical Use of Biologics in Orthopaedic Surgery: Consensus Recommendations From the 2018 AAOS/NIH U-13 Conference. J Am Acad Orthop Surg. 2019 Jan 15;27(2):e50-e63. doi: 10.5435/JAAOS-D-18-00305.

    PubMed 30300216

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing PRP injection, Bone Marrow Concentrate (BMAC) and Hyaluronic Acid (Viscosupplementation) in people with Musculoskeletal Diseases or Conditions, run by PROREGEN at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gabriela D Daiprai (51995342193, gdaiprai@universo.univates.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain scale (time frame: From registration until six months, one year, and two years. Two years is the final follow-up period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07434115, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in