Knee OsteoarthritisNCT02964143
Clinical Investigation to Compare the Safety and Efficacy of Cellular Matrix to Those of Ostenil® Plus and to Those of PRP Only
A study testing Cellular Matrix / A-CP HA, Ostenil® Plus and RegenKit-BCT-1 in people with Knee Osteoarthritis, run by Regen Lab SA.
Trial summary
Platelet-rich plasma (PRP) is an autologous product prepared from the patient's own blood, representing a powerful source of platelet-derived growth factors, particularly useful in the field of regenerative medicine. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Cellular Matrix / A-CP HA, Ostenil® Plus and RegenKit-BCT-1
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to Dec 2020
- Phase
- Interventional
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic knee osteoarthritis of a unilateral knee, characterized by pain at walking (WOMAC A1 score assessed over the previous 24 hours on a 100-mm VAS: 50 ≤ WOMAC A1 ≤ 90) or reduced joint function (total WOMAC C score assessed or over the previous 24 hours on a 100-mmVAS: 50 ≤ WOMAC A1 ≤ 90)
- Femoro-tibial knee osteoarthritis defined according to ACR criteria
- Bilateral knee osteoarthritis is allowed, provided the contralateral knee is characterized by a maximum pain of 30 on a 0 to 100 mm scale and doesn't require systemic analgesic treatment, with the exception of paracetamol up to the maximum dose of 4 g per day
- Radiographic femoro-tibial knee osteoarthritis (radiograph not older than 3 months) Kellgren \& Lawrence grades of II-III
- Outpatient capable of walking 50 meters without assistance
- Signature of the informed consent form
- Capable of understanding the study's imperatives, as well as written instructions
- Capable of filling-out evaluation questionnaires
Who cannot join
- Radiographic femoro-tibial knee osteoarthritis Kellgren \& Lawrence grades of I or IV
- Bilateral knee osteoarthritis, characterized by pain greater than 30 of both knees evaluated on a 0 to 100-mm scale and requiring systemic analgesic treatment or paracetamol greater than 4g/ day
- Viscosupplementation in the past 3 months
- Corticosteroid injection in the past 3 months
- PRP or PRP/HA injection in the past 12 months
- Any surgery of the knee planned during the next 6 months
Show all 32Show fewer
- Systematic use of corticosteroids (except those that are inhaled) or level III analgesics in the past 3 months and NSAID during the past month
- Treatment with slow-acting anti-rheumatic drugs (diacerhein, soybean or avocado unsaponifiables, chondroitin sulfate, glucosamine) started in the past 6 months
- History of allergy to hyaluronic acid
- Auto-immune disease (rheumatoid arthritis, lupus)
- Surgery of the affected knee in the past 3 months
- Infection of the affected knee in the past 6 months
- Rheumatologic disorder other than arthritis
- Clinical evidence of local inflammation such as redness or heat of the joint
- Any knee surgery planned within 6 months
- Hereditary or acquired hematologic or clotting disorders, such as drepanocytosis, platelet dysfunction, thrombocytopenia (<150'000 platelets/mm3), etc.
- Anemia (Hemoglobin < 10g/dl)
- Anticoagulant treatment (patients under antiaggregant treatment can take part to this study as long as their clotting time (CT) is within the reference value)
- Acute infection
- Malignant disease (especially bone and hematological)
- Recent fever or serious disorders (cardiovascular pathology, active gastroduodenal ulcer, digestive hemorrhage, liver disease, etc.)
- Patient with renal impairment (creatinine clearance below 45 ml / min)
- Patient with liver failure, pending or who have recently received a liver transplant
- Infectious diseases
- Pregnancy or breastfeeding or planning pregnancy during the course of the study
- Immunosuppression
- Insulin-dependent diabetic patient
- Participation ongoing or in the past 3 months in another clinical study
- Participation to another osteoarthritis clinical study during the past year
- Refusal to sign or inability to give Informed Consent
- Patient unable to submit to the constraints of the protocol, including patient whose mental condition does not allow him to understand the nature, objectives and possible consequences of the study
- Any other reason which, in the opinion of the investigator, may interfere with the proper conduct of the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective, Randomized, Controlled Clinical Investigation to Compare the Safety and Performance of a Combination of Autologous Platelet-rich Plasma (PRP) and Hyaluronic Acid Prepared With Cellular MatrixTM to Those of Ostenil® Plus and to Those of PRP Alone in the Treatment of Mild to Moderate Osteoarthritis of the Knee
Platelet-rich plasma (PRP) is an autologous product prepared from the patient's own blood, representing a powerful source of platelet-derived growth factors, particularly useful in the field of regenerative medicine. The active and sequential secretion of these growth factors induces different cell signaling cascades that activate angiogenesis, cell proliferation, cell differentiation, eventually leading to new matrix synthesis and tissue regeneration.
The potential benefits from the use of PRP for the treatment of cartilage defects rely on a number of studies conducted in validated animal models or in vitro, demonstrating the ability of PRP to stimulate collagen production and proteoglycans synthesis, as well as the proliferation and differentiation of mesenchymal stem cells into chondrocytes. Additionally, an increasing number of clinical studies shows an improvement of symptoms, most especially pain, without any occurrence of serious adverse events.
Read more
Hyaluronic acid (HA), as one of the major components of the synovial fluid surrounding the cartilage, assumes an important role in the viscoelastic properties of the articular cartilage, conferring its shock absorbing and lubricating functions.
It was demonstrated that rheological properties of synovial fluid decrease with aging and in patients suffering from osteoarthritis. Nowadays, intra-articular injections of hyaluronic acid represent a well recommended therapeutic option to relieve osteoarthritic symptoms, conferring a mechanical action on joints structures, thus leading to reduced pain and improved joint function Based on these data, it seems reasonable to hypothesize that a combination of both PRP and hyaluronic acid could provide greater benefits compared to the administration of each product alone, as their effects on osteoarthritis improvement are based on different mechanisms of action. In fact, on one side PRP promotes cartilage regeneration, while on the other side the HA acts as 3-dimensional support mesh for PRP, providing optimal release of platelets growth factors, strengthening and extending in time the activity of PRP.
Cellular MatrixTM is a CE-marked class III medical device manufactured by the Swiss company RegenLab SA. Cellular MatrixTM allows to prepare autologous PRP combined with a non-crosslinked hyaluronic acid in a safe, rapid manner and in a single step. The PRP/HA combination is intended to be injected intra-articularly, in order to relieve osteoarthritic symptoms and to improve joint mobility and function. Therefore, the PRP/HA combination might represent a novel therapeutic option for patient suffering from knee osteoarthritis.
This study will evaluate whether the effects of a PRP/HA combination prepared with Cellular Matrix™, when injected intra-articularly for the treatment of mild to moderate knee osteoarthritis, are superior to those of a well-recognized hyaluronic acid treatment (Ostenil® Plus), on one hand, and to those of PRP alone, on the other hand.
- Conditions
- Knee Osteoarthritis
- Being tested
- Cellular Matrix / A-CP HA, Ostenil® Plus, RegenKit-BCT-1
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cellular Matrix / A-CP HADevice
Treatment with 2 injections of Cellular Matrix / A-CP HA Kit, administered 2 months apart; Cellular Matrix / A-CP HA Kit is designed for the safe, rapid and extemporaneous preparation of a cellular matrix of autologous PRP combined with HA. The Cellular Matrix / A-CP HA Kit is a single-use medical device including hematology tubes (A-CP HA tube), designed for blood collection and PRP/HA preparation after 5 min centrifugation. This tube contains a non-crosslinked hyaluronic acid (MW 1550 kDa) solution, a gel acting as a cell separator, and a sodium citrate acting as an anticoagulant. During centrifugation, the separator gel moves to form a barrier that separates red blood cells from other blood components. The HA, which migrates to the top of the gradient during centrifugation, can be mixed with PRP in order to give rise to a ready-to-use PRP/HA preparation.
Ostenil® PlusDevice
Treatment with 2 injections of Ostenil® Plus, administered one week apart; Ostenil® Plus is a solution of sodium hyaluronate obtained by fermentation, containing 0.5% mannitol, a free radical scavenger, which helps to stabilize the chains of sodium hyaluronate. The product is intended to be used for pain and restricted mobility in degenerative and traumatic changes of the knee joint.
RegenKit-BCT-1Device
Treatment with 2 injections of RegenKit-BCT-1, administered 1 month apart; RegenKit-BCT-1 is designed for the safe, rapid and extemporaneous preparation of autologous platelet-rich plasma. RegenKit-BCT-1 is a single-use medical device including an hematology tube (Regen BCT tube), designed for blood collection and PRP preparation after 5 min centrifugation, and all necessary material for venipuncture and PRP injection. The Regen BCT tube contains a gel acting as a cell separator and a sodium citrate acting as an anticoagulant. During centrifugation, the separator gel moves to form a barrier that separates red blood cells from other blood components.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients from this group will be treated with a combination of platelet-rich plasma (PRP) and hyaluronic acid (HA) prepared with the Cellular Matrix / A-CP HA medical device Receives: Device: Cellular Matrix / A-CP HA |
| Control group 1 | Active comparator | Patients from this group will be treated with a well-recognized hyaluronic acid named Ostenil® Plus Receives: Device: Ostenil® Plus |
| Control group 2 | Active comparator | Patients from this group will be treated with PRP alone, prepared with RegenKit-BCT-1 Receives: Device: RegenKit-BCT-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of the pain between baseline and Month 6
For each group, pain will be evaluated using the WOMAC A subscale; each item of this subscale will be scored using a 100-mm VAS (Visual Analogue Scale) at baseline and Month 6. The total WOMAC A score will be reported as a summed score of this subscale.
Measured: 6 months
Secondary outcomes (11)
Variation of pain between baseline and Month 1, Month 2 and Month 4
For each group, pain will be evaluated using the WOMAC A subscale; each item of this subscale will be scored using a 100-mm VAS (Visual Analogue Scale) at baseline, Month 1, Month 2, and Month 4. The total WOMAC A score will be reported as a summed score of all items of this subscale.
Measured: 1, 2 and 4 months
Variation of stiffness between baseline and Month 1, Month 2, Month 4 and Month 6
For each group, stiffness will be evaluated using the WOMAC B subscale; each item of this subscale will be scored using a 100-mm VAS (Visual Analogue Scale) at baseline, Month 1, Month 2, Month 4 and Month 6. The total WOMAC B score will be reported as a summed score of all items of this subscale.
Measured: 1, 2, 4 and 6 months
Variation of physical function between baseline and Month 1, Month 2, Month 4 and Month 6
For each group, physical function will be evaluated using the WOMAC C subscale; each item of this subscale will be scored using a 100-mm VAS (Visual Analogue Scale) at baseline, Month 1, Month 2, Month 4 and Month 6. The total WOMAC C score will be reported as a summed score of all items of this subscale.
Measured: 1, 2, 4 and 6 months
Variation of overall knee osteoarthritis symptoms between baseline and Month 1, Month 2, Month 4 and Month 6
For each group, overall knee osteoarthritis will be evaluated using the total WOMAC questionnaire; each item of this questionnaire will be scored using a 100-mm VAS (Visual Analogue Scale) at baseline, Month 1, Month 2, Month 4 and Month 6. The total WOMAC score will be reported as a summed score of all items of the questionnaire.
Measured: 1, 2, 4 and 6 months
Variation of the quality of life between baseline and all time points
Quality of life will be assessed using the SF-36 questionnaire that will be given to patients at each visit throughout the study.
Measured: 1, 2, 4 and 6 months
Patient Global Assessment of the treatment received
Measured: 6 months
Clinician Global Assessment of the treatment
Measured: 6 months
Percentage of OMERACT-OARSI responders at Month 1, Month 2, Month 4 and Month 6
Measured: 1, 2, 4 and 6 months
Percentage of patients requiring an injection of the combination of PRP/HA prepared with Cellular Matrix / A-CP HA at Month 6
Measured: 6 months
Number of local and systemic side effects throughout the study period
Measured: 12 months
Cartilage structure
The cartilage structure will be evaluated on the basis of Magnetic Resonance Imaging (MRI) assays at baseline (before receiving the treatment), 6 and 12 months. Differences on the T1 relaxation time parameter will be evaluated at different time points.
Measured: 6 and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study start1 Jun 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regen Lab SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02964143
- Sponsor's protocol ID
- 2016-OA-001
- Status last verified
- Mar 2020
- First submitted
- 13 Oct 2016
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Controlled Clinical Investigation to Compare the Safety and Performance of a Combination of Autologous Platelet-rich Plasma (PRP) and Hyaluronic Acid Prepared With Cellular MatrixTM to Those of Ostenil® Plus and to Those of PRP Alone in the Treatment of Mild to Moderate Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT02964143
- Acronym / sponsor ID
- 2016-OA-001
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- Regen Lab SAIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 15 Nov 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.
Platelet-rich plasma (PRP) is an autologous product prepared from the patient's own blood, representing a powerful source of platelet-derived growth factors, particularly useful in the field of regenerative medicine. The active and sequential secretion of these growth factors induces different cell signaling cascades that activate angiogenesis, cell proliferation, cell differentiation, eventually leading to new matrix synthesis and tissue regeneration.
The potential benefits from the use of PRP for the treatment of cartilage defects rely on a number of studies conducted in validated animal models or in vitro, demonstrating the ability of PRP to stimulate collagen production and proteoglycans synthesis, as well as the proliferation and differentiation of mesenchymal stem cells into chondrocytes. Additionally, an increasing number of clinical studies shows an improvement of symptoms, most especially pain, without any occurrence of serious adverse events.
Hyaluronic acid (HA), as one of the major components of the synovial fluid surrounding the cartilage, assumes an important role in the viscoelastic properties of the articular cartilage, conferring its shock absorbing and lubricating functions.
It was demonstrated that rheological properties of synovial fluid decrease with aging and in patients suffering from osteoarthritis. Nowadays, intra-articular injections of hyaluronic acid represent a well recommended therapeutic option to relieve osteoarthritic symptoms, conferring a mechanical action on joints structures, thus leading to reduced pain and improved joint function Based on these data, it seems reasonable to hypothesize that a combination of both PRP and hyaluronic acid could provide greater benefits compared to the administration of each product alone, as their effects on osteoarthritis improvement are based on different mechanisms of action. In fact, on one side PRP promotes cartilage regeneration, while on the other side the HA acts as 3-dimensional support mesh for PRP, providing optimal release of platelets growth factors, strengthening and extending in time the activity of PRP.
Cellular MatrixTM is a CE-marked class III medical device manufactured by the Swiss company RegenLab SA. Cellular MatrixTM allows to prepare autologous PRP combined with a non-crosslinked hyaluronic acid in a safe, rapid manner and in a single step. The PRP/HA combination is intended to be injected intra-articularly, in order to relieve osteoarthritic symptoms and to improve joint mobility and function. Therefore, the PRP/HA combination might represent a novel therapeutic option for patient suffering from knee osteoarthritis.
This study will evaluate whether the effects of a PRP/HA combination prepared with Cellular Matrix™, when injected intra-articularly for the treatment of mild to moderate knee osteoarthritis, are superior to those of a well-recognized hyaluronic acid treatment (Ostenil® Plus), on one hand, and to those of PRP alone, on the other hand.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Cellular Matrix / A-CP HAPatients from this group will be treated with a combination of platelet-rich plasma (PRP) and hyaluronic acid (HA) prepared with the Cellular Matrix / A-CP HA medical device |
| Control group 1 | Active comparator | Device: Ostenil® PlusPatients from this group will be treated with a well-recognized hyaluronic acid named Ostenil® Plus |
| Control group 2 | Active comparator | Device: RegenKit-BCT-1Patients from this group will be treated with PRP alone, prepared with RegenKit-BCT-1 |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Symptomatic knee osteoarthritis of a unilateral knee, characterized by pain at walking (WOMAC A1 score assessed over the previous 24 hours on a 100-mm VAS: 50 ≤ WOMAC A1 ≤ 90) or reduced joint function (total WOMAC C score assessed or over the previous 24 hours on a 100-mmVAS: 50 ≤ WOMAC A1 ≤ 90)
- Femoro-tibial knee osteoarthritis defined according to ACR criteria
- Bilateral knee osteoarthritis is allowed, provided the contralateral knee is characterized by a maximum pain of 30 on a 0 to 100 mm scale and doesn't require systemic analgesic treatment, with the exception of paracetamol up to the maximum dose of 4 g per day
- Radiographic femoro-tibial knee osteoarthritis (radiograph not older than 3 months) Kellgren \& Lawrence grades of II-III
- Outpatient capable of walking 50 meters without assistance
Key exclusion criteria (32 listed)
- Radiographic femoro-tibial knee osteoarthritis Kellgren \& Lawrence grades of I or IV
- Bilateral knee osteoarthritis, characterized by pain greater than 30 of both knees evaluated on a 0 to 100-mm scale and requiring systemic analgesic treatment or paracetamol greater than 4g/ day
- Viscosupplementation in the past 3 months
- Corticosteroid injection in the past 3 months
- PRP or PRP/HA injection in the past 12 months
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 |
|---|---|---|
| Cellular Matrix / A-CP HATreatment with 2 injections of Cellular Matrix / A-CP HA Kit, administered 2 months apart; Cellular Matrix / A-CP HA Kit is designed for the safe, rapid and extemporaneous preparation of a cellular matrix of autologous PRP combined with HA. The Cellular Matrix / A-CP HA Kit is a single-use medical device including hematology tubes (A-CP HA tube), designed for blood collection and PRP/HA preparation after 5 min centrifugation. This tube contains a non-crosslinked hyaluronic acid (MW 1550 kDa) solution, a gel acting as a cell separator, and a sodium citrate acting as an anticoagulant. During centrifugation, the separator gel moves to form a barrier that separates red blood cells from other blood components. The HA, which migrates to the top of the gradient during centrifugation, can be mixed with PRP in order to give rise to a ready-to-use PRP/HA preparation. | Device | Experimental group |
| Ostenil® PlusTreatment with 2 injections of Ostenil® Plus, administered one week apart; Ostenil® Plus is a solution of sodium hyaluronate obtained by fermentation, containing 0.5% mannitol, a free radical scavenger, which helps to stabilize the chains of sodium hyaluronate. The product is intended to be used for pain and restricted mobility in degenerative and traumatic changes of the knee joint. | Device | Control group 1 |
| RegenKit-BCT-1Treatment with 2 injections of RegenKit-BCT-1, administered 1 month apart; RegenKit-BCT-1 is designed for the safe, rapid and extemporaneous preparation of autologous platelet-rich plasma. RegenKit-BCT-1 is a single-use medical device including an hematology tube (Regen BCT tube), designed for blood collection and PRP preparation after 5 min centrifugation, and all necessary material for venipuncture and PRP injection. The Regen BCT tube contains a gel acting as a cell separator and a sodium citrate acting as an anticoagulant. During centrifugation, the separator gel moves to form a barrier that separates red blood cells from other blood components. | Device | Control group 2 |
Primary outcome
Variation of the pain between baseline and Month 6
Time frame: 6 months
For each group, pain will be evaluated using the WOMAC A subscale; each item of this subscale will be scored using a 100-mm VAS (Visual Analogue Scale) at baseline and Month 6. The total WOMAC A score will be reported as a summed score of this subscale.
11 secondary outcomes
Variation of pain between baseline and Month 1, Month 2 and Month 4
Time frame: 1, 2 and 4 months
Variation of stiffness between baseline and Month 1, Month 2, Month 4 and Month 6
Time frame: 1, 2, 4 and 6 months
Variation of physical function between baseline and Month 1, Month 2, Month 4 and Month 6
Time frame: 1, 2, 4 and 6 months
Variation of overall knee osteoarthritis symptoms between baseline and Month 1, Month 2, Month 4 and Month 6
Time frame: 1, 2, 4 and 6 months
Variation of the quality of life between baseline and all time points
Time frame: 1, 2, 4 and 6 months
Patient Global Assessment of the treatment received
Time frame: 6 months
Clinician Global Assessment of the treatment
Time frame: 6 months
Percentage of OMERACT-OARSI responders at Month 1, Month 2, Month 4 and Month 6
Time frame: 1, 2, 4 and 6 months
Percentage of patients requiring an injection of the combination of PRP/HA prepared with Cellular Matrix / A-CP HA at Month 6
Time frame: 6 months
Number of local and systemic side effects throughout the study period
Time frame: 12 months
Cartilage structure
Time frame: 6 and 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Cellular Matrix / A-CP HA, Ostenil® Plus and RegenKit-BCT-1 in people with Knee Osteoarthritis, run by Regen Lab SA.
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 8 inclusion and 32 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 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Contact Valérie de Fourmestraux, PhD (+41(0)218640110 ext. 118, vdefourmestraux@regenlab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of the pain between baseline and Month 6 (time frame: 6 months). 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 11 Mar 2020.