OsteoarthrosisPhase 1/2NCT02923310
Evaluation of Two Types of PRP in Knee Osteoarthritis
A Phase 1/2 study testing Platelets Rich Plasma, Leucocyte - Platelets Rich Plasma and Hialuronic Acid in people with Osteoarthrosis, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
OOsteoarthritis (OA) is a chronic joint disease characterized by progressive degeneration of cartilage and bone tissue, leading to the appearance of subchondral cysts, osteophyte formation and synovial inflammation. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthrosis
- What is being tested?
- Platelets Rich Plasma, Leucocyte - Platelets Rich Plasma and Hialuronic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2013to Sep 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with Osteoarthrits
Who cannot join
- diabetes, rheumatoid arthritis, axial deviation (varus> 10 degrees valgus> 10 degrees), blood disorders (coagulopathy and platelet changes), cardiovascular diseases, infections, immunosuppression, patients on anticoagulant therapy or antiplatelet use of nonsteroidal anti-inflammatory 5 days before blood collection, patients with hemoglobin concentrations <11 and platelet count <150,000 mm³.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hemotherapy and Hematology Center
Campinas, São Paulo
José F Lana, MD, +5519999600602, osefabiolana@gmail.com
About this study
OOsteoarthritis (OA) is a chronic joint disease characterized by progressive degeneration of cartilage and bone tissue, leading to the appearance of subchondral cysts, osteophyte formation and synovial inflammation. Although the causes of OA are still poorly understood, biomechanical stresses able to reach the articular cartilage and subchondral bone, biochemical changes in cartilage and synovial membrane, as well as genetic factors are important items in its pathogenesis. Although there is no cure for OA, treatment is directed to each individual patient, seeking to minimize pain, maintain or improve joint range of motion and limit disability. New therapies able to accelerate regeneration and tissue repair process are being discussed. The viscosupplementation with hyaluronic acid (HA) have been shown to be an effective and safe treatment alternative in the fight against knee OA, in addition to HA, worth highlighting the therapeutic effects of growth factors derived from autologous platelets. The platelet-rich plasma (PRP) appears as an autologous therapy, non-immunogenic, able to induce healing and repair of bone soft tissue. This study aims to evaluate the clinical efficacy, comparing treatment with PRP and the combination of HA and PRP in the treatment of knee OA. To this, 120 will be selected OA patients with mild, moderate and severe (Grade II, III and IV). Selected patients will be scheduled for the procedures and randomly assigned randomly. In PRP be determined concentrations of the growth factor PDGF, TGFb 1, VEGF, EGF, by the method Bio Plex®.\. Functional evaluations will be conducted through questionnaires (WOMAC and SF-36) as measures of function and quality of self-reported life. The walking and strength test will be performed before and during periods of 90.180 and 360 days after the first application. The main motivation for the development of this study is the lack of randomized, double-blind clinical studies in the literature, and also based on the favorable results researchers have obtained, both with the use of HA, as the use of PRP in accelerating the process scar, preventing the development of arthrosis above. Therefore, we believe that the PRP, with its growth factors associated with synthetic HA play a synergistic action that should be studied in detail, in order to establish an effective therapeutic approach in the treatment of patients with knee OA.
- Conditions
- Osteoarthrosis
- Being tested
- Platelets Rich Plasma, Leucocyte - Platelets Rich Plasma, Hialuronic Acid
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelets Rich PlasmaBiological
Leucocyte - Platelets Rich PlasmaBiological
Hialuronic AcidDrug
| Study group | Role | What they receive |
|---|---|---|
| Osteoarthrits G II and III | Experimental | Group of treatment Receives: Biological: Platelets Rich Plasma; Biological: Leucocyte - Platelets Rich Plasma; Drug: Hialuronic Acid |
| Osteoarthrits GIV | Experimental | Group of treatment Receives: Biological: Platelets Rich Plasma; Biological: Leucocyte - Platelets Rich Plasma; Drug: Hialuronic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Womac
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startNov 2013
- Primary completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joyce Maria Annichino Bizzacchi, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923310
- Sponsor's protocol ID
- 19466713.6.0000.5404
- Status last verified
- Sep 2016
- First submitted
- 30 Sep 2016
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Types of PRP in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02923310
- Acronym / sponsor ID
- 19466713.6.0000.5404
- Conditions
- Osteoarthrosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Sep 2016 (actual)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OOsteoarthritis (OA) is a chronic joint disease characterized by progressive degeneration of cartilage and bone tissue, leading to the appearance of subchondral cysts, osteophyte formation and synovial inflammation. Although the causes of OA are still poorly understood, biomechanical stresses able to reach the articular cartilage and subchondral bone, biochemical changes in cartilage and synovial membrane, as well as genetic factors are important items in its pathogenesis. Although there is no cure for OA, treatment is directed to each individual patient, seeking to minimize pain, maintain or improve joint range of motion and limit disability. New therapies able to accelerate regeneration and tissue repair process are being discussed. The viscosupplementation with hyaluronic acid (HA) have been shown to be an effective and safe treatment alternative in the fight against knee OA, in addition to HA, worth highlighting the therapeutic effects of growth factors derived from autologous platelets. The platelet-rich plasma (PRP) appears as an autologous therapy, non-immunogenic, able to induce healing and repair of bone soft tissue. This study aims to evaluate the clinical efficacy, comparing treatment with PRP and the combination of HA and PRP in the treatment of knee OA. To this, 120 will be selected OA patients with mild, moderate and severe (Grade II, III and IV). Selected patients will be scheduled for the procedures and randomly assigned randomly. In PRP be determined concentrations of the growth factor PDGF, TGFb 1, VEGF, EGF, by the method Bio Plex®.\. Functional evaluations will be conducted through questionnaires (WOMAC and SF-36) as measures of function and quality of self-reported life. The walking and strength test will be performed before and during periods of 90.180 and 360 days after the first application. The main motivation for the development of this study is the lack of randomized, double-blind clinical studies in the literature, and also based on the favorable results researchers have obtained, both with the use of HA, as the use of PRP in accelerating the process scar, preventing the development of arthrosis above. Therefore, we believe that the PRP, with its growth factors associated with synthetic HA play a synergistic action that should be studied in detail, in order to establish an effective therapeutic approach in the treatment of patients with knee OA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteoarthrits G II and III | Experimental | Biological: Platelets Rich Plasma, Biological: Leucocyte - Platelets Rich Plasma, Drug: Hialuronic AcidGroup of treatment |
| Osteoarthrits GIV | Experimental | Biological: Platelets Rich Plasma, Biological: Leucocyte - Platelets Rich Plasma, Drug: Hialuronic AcidGroup of treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Osteoarthrits
Key exclusion criteria (1 listed)
- diabetes, rheumatoid arthritis, axial deviation (varus> 10 degrees valgus> 10 degrees), blood disorders (coagulopathy and platelet changes), cardiovascular diseases, infections, immunosuppression, patients on anticoagulant therapy or antiplatelet use of nonsteroidal anti-inflammatory 5 days before blood collection, patients with hemoglobin concentrations <11 and platelet count <150,000 mm³.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelets Rich Plasma | Biological | Osteoarthrits G II and III, Osteoarthrits GIV |
| Leucocyte - Platelets Rich Plasma | Biological | Osteoarthrits G II and III, Osteoarthrits GIV |
| Hialuronic Acid | Drug | Osteoarthrits G II and III, Osteoarthrits GIV |
Primary outcome
Womac
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
- Individual participant dataSharing planned: No
Related trials for Osteoarthrosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Platelets Rich Plasma, Leucocyte - Platelets Rich Plasma and Hialuronic Acid in people with Osteoarthrosis, run by University of Campinas, Brazil 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Oct 2016. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Womac (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2016.