Knee OsteoarthritisNCT03328728
Cellular Matrix Device for the Treatment of Mild to Moderate Knee Osteoarthritis
A study testing Cellular Matrix / A-CP HA Kit and Synvisc-One in people with Knee Osteoarthritis, run by Regen Lab SA at 1 site in France.
Trial summary
This is a non-inferiority study on 190 patients to evaluate whether a treatment based on the combination of autologous platelet-rich plasma and hyaluronic acid obtained with Cellular Matrix represents a therapeutic advantage to relieve symptoms associated with a mild to moderate knee osteoarthritis (particularly pain… 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 Kit and Synvisc-One
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jul 2017to 31 Mar 2021
- 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
- femorotibial knee osteoarthritis defined according to the American College of Rheumatology (ACR) criteria
- 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 Visual Analog Scale (VAS): 50 ≤ WOMAC A1 ≤ 90) or reduced joint function (total WOMAC C score assessed or over the previous 24 hours on a 100-mm VAS: 50 ≤ WOMAC A1 ≤ 90)
- 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 femorotibial 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 29Show fewer
- Systematic use of corticosteroids (except those that are inhaled) or level III analgesics in the past 3 months and NSAID (non-steroidal anti-inflammatory drugs) 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
- 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
- serious disorders (cardiovascular pathology, active gastroduodenal ulcer, digestive hemorrhage)
- Patient with renal impairment (creatinine clearance below 45 ml / min)
- Patient with liver failure, pending or who have recently received a liver transplant
- 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
- 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
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Clinique Médipôle garonne
Toulouse, Haute-Garonne, 31036
Philippe Adam, MD
About this study
Official title: A Prospective, Multicenter, Randomized,Controlled Study to Compare the Safety and Performance of Cellular Matrix Device (Combination of Autologous Platelet-rich Plasma and Non-crosslinked Hyaluronic Acid) to Those of Synvisc-One (Crosslinked Hyaluronic Acid) for the Treatment of Mild to Moderate Knee Osteoarthritis
This is a non-inferiority study on 190 patients to evaluate whether a treatment based on the combination of autologous platelet-rich plasma and hyaluronic acid obtained with Cellular Matrix represents a therapeutic advantage to relieve symptoms associated with a mild to moderate knee osteoarthritis (particularly pain on walking) compared to hyaluronic acid only (Synvisc®-One).
Read the detailed description
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 Matrix/A-CP HA Kit is a medical device manufactured by the Swiss company Regen Lab SA. Cellular Matrix/A-CP HA Kit 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 the effects of a single intra-articular injection of a PRP/HA combination prepared with Cellular Matrix/A-CP HA Kit, compared to those of a intra-articular single injection of a well-recognized hyaluronic acid treatment (Synvisc®-One), to relieve symptoms associated with mild to moderate knee osteoarthritis.
- Conditions
- Knee Osteoarthritis
- Being tested
- Cellular Matrix / A-CP HA Kit, Synvisc-One
- 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 HA KitDevice
Treatment with a single intra-articular injection in the knee of Cellular Matrix / A-CP HA Kit; 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.
Synvisc-OneDevice
Treatment with a single intra-articular injection in the knee of Synvisc-One; Synvisc-One (hylan G-F 20) is a sterile, nonpyrogenic, elastoviscous fluid containing hylans. Hylans are derivatives of hyaluronans (sodium salt of hyaluronic acid). Hylan A has an average molecular weight of 6,000,000 daltons and hylan B is a hydrated gel. Hylan G-F 20 contains hylan A and hylan B (8.0 mg per ml) in buffered physiological sodium chloride solution.
| Study group | Role | What they receive |
|---|---|---|
| Cellular Matrix / A-CP HA Kit | Experimental | One intra-articular injection of a combination of PRP and non-crosslinked HA Receives: Device: Cellular Matrix / A-CP HA Kit |
| Synvisc-One | Active comparator | One intra-articular injection of a crosslinked HA Receives: Device: Synvisc-One |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline pain on walking (Western Ontario & McMaster Universities [WOMAC] A1 of the WOMAC questionaire) at 6 months
For each group, pain on walking will be evaluated using a 100-mm Visual Analog Scale (VAS), where 0= no pain and 100 = extreme pain
Measured: 6 months
Secondary outcomes (13)
Change from Baseline pain on walking at 1 and 3 months
For each group, pain on walking will be evaluated using a 100-mm Visual Analog Scale (VAS), where 0= no pain and 100 = extreme pain
Measured: 1 and 3 months
Change from Baseline overall knee osteoarthritis symptoms at 1, 3 and 6 Months
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 at baseline, Month 1, Month 3, and Month 6. The total WOMAC score will be reported as a summed score of all items of the questionnaire, with 0 is the minimum and 2400 is the maximum.
Measured: 1, 3 and 6 months
Change from Baseline pain at 1, 3 and 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 at baseline, Month 1, Month 3, and Month 6. The total WOMAC A score will be reported as a summed score of all items of this subscale, where 0 = is the minimum (no pain) and 500 is the maximum (extreme pain).
Measured: 1, 3 and 6 months
Change from Baseline stiffness at 1, 3 and 6 Months
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 at baseline, Month 1, Month 3, and Month 6. The total WOMAC B score will be reported as a summed score of all items of this subscale, where 0 = is the minimum (no stiffness) and 200 is the maximum (extreme stiffness).
Measured: 1, 3 and 6 months
Change from Baseline physical function at 1, 3 and 6 Months
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 at baseline, Month 1, Month 3, and Month 6. The total WOMAC C score will be reported as a summed score of all items of this subscale, where 0 = is the minimum (no difficulty to perform activities) and 1700 is the maximum (extreme difficulty to perform activities).
Measured: 1, 3 and 6 months
Change from Baseline quality of life at all time points
Quality of life will be assessed using the 36-Item Short Form (SF-36) survey that will be given to patients at each visit throughout the study.
Measured: 1, 3 and 6 months
Patient Global Assessment of the treatment received
Patient Global Assessment will be performed using a 5-point numeric scale at 1, 3 and 6 Months, with 1 = completely dissatisfied, 2= dissatisfied, 3 = no change, 4=satisfied , 5= completely satisfied
Measured: 1, 3 and 6 months
Clinician Global Assessment of the treatment received
Patient Global Assessment will be performed using a 5-point numeric scale at 1, 3 and 6 Months, 1 = completely dissatisfied, 2= dissatisfied, 3 = no change, 4=satisfied , 5= completely satisfied
Measured: 1, 3 and 6 months
Percentage of OMERACT-OARSI (Outcome Measure in Rheumatology - Osteoarthitis Research Society International) responders at 1, 3 and 6 Months
Measured: 1, 3 and 6 months
Percentage of patients requiring an injection of the combination of PRP/HA prepared with Cellular Matrix / A-CP HA at 6 Months
Measured: 6 months
Number of local and systemic side effects throughout the study period
Measured: 6 months
Cartilage structure
The cartilage structure will be evaluated on the basis of Magnetic Resonance Imaging (MRI) assays at baseline (before receiving the treatment) and 6 months. Differences on the T1 relaxation time parameter will be evaluated at different time points.
Measured: 6 months
Rescue treatment consumption at 1, 3 and 6 Months
Consumption of authorized medication to relieve pain, according to the patient's diary
Measured: 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start18 Jul 2017
- Primary completion31 Mar 2021 (estimated)
- Study completion31 Mar 2021 (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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regen Lab SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe Adam, MD, Principal investigator, Clinique Médipôle Garonne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328728
- Sponsor's protocol ID
- 2015-OA-003
- Status last verified
- Nov 2019
- First submitted
- 24 Oct 2017
- Last updated
- 14 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized,Controlled Study to Compare the Safety and Performance of Cellular Matrix Device (Combination of Autologous Platelet-rich Plasma and Non-crosslinked Hyaluronic Acid) to Those of Synvisc-One (Crosslinked Hyaluronic Acid) for the Treatment of Mild to Moderate Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03328728
- Acronym / sponsor ID
- 2015-OA-003
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Regen Lab SAIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2017 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 1 Nov 2017 (actual)
- 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.
This is a non-inferiority study on 190 patients to evaluate whether a treatment based on the combination of autologous platelet-rich plasma and hyaluronic acid obtained with Cellular Matrix represents a therapeutic advantage to relieve symptoms associated with a mild to moderate knee osteoarthritis (particularly pain on walking) compared to hyaluronic acid only (Synvisc®-One).
Detailed description
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 Matrix/A-CP HA Kit is a medical device manufactured by the Swiss company Regen Lab SA. Cellular Matrix/A-CP HA Kit 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 the effects of a single intra-articular injection of a PRP/HA combination prepared with Cellular Matrix/A-CP HA Kit, compared to those of a intra-articular single injection of a well-recognized hyaluronic acid treatment (Synvisc®-One), to relieve symptoms associated with mild to moderate knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cellular Matrix / A-CP HA Kit | Experimental | Device: Cellular Matrix / A-CP HA KitOne intra-articular injection of a combination of PRP and non-crosslinked HA |
| Synvisc-One | Active comparator | Device: Synvisc-OneOne intra-articular injection of a crosslinked HA |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- femorotibial knee osteoarthritis defined according to the American College of Rheumatology (ACR) criteria
- 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 Visual Analog Scale (VAS): 50 ≤ WOMAC A1 ≤ 90) or reduced joint function (total WOMAC C score assessed or over the previous 24 hours on a 100-mm VAS: 50 ≤ WOMAC A1 ≤ 90)
- 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 femorotibial 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 (29 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 HA KitTreatment with a single intra-articular injection in the knee of Cellular Matrix / A-CP HA Kit; 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 | Cellular Matrix / A-CP HA Kit |
| Synvisc-OneTreatment with a single intra-articular injection in the knee of Synvisc-One; Synvisc-One (hylan G-F 20) is a sterile, nonpyrogenic, elastoviscous fluid containing hylans. Hylans are derivatives of hyaluronans (sodium salt of hyaluronic acid). Hylan A has an average molecular weight of 6,000,000 daltons and hylan B is a hydrated gel. Hylan G-F 20 contains hylan A and hylan B (8.0 mg per ml) in buffered physiological sodium chloride solution. | Device | Synvisc-One |
Primary outcome
Change from Baseline pain on walking (Western Ontario & McMaster Universities [WOMAC] A1 of the WOMAC questionaire) at 6 months
Time frame: 6 months
For each group, pain on walking will be evaluated using a 100-mm Visual Analog Scale (VAS), where 0= no pain and 100 = extreme pain
13 secondary outcomes
Change from Baseline pain on walking at 1 and 3 months
Time frame: 1 and 3 months
Change from Baseline overall knee osteoarthritis symptoms at 1, 3 and 6 Months
Time frame: 1, 3 and 6 months
Change from Baseline pain at 1, 3 and 6 Months
Time frame: 1, 3 and 6 months
Change from Baseline stiffness at 1, 3 and 6 Months
Time frame: 1, 3 and 6 months
Change from Baseline physical function at 1, 3 and 6 Months
Time frame: 1, 3 and 6 months
Change from Baseline quality of life at all time points
Time frame: 1, 3 and 6 months
Patient Global Assessment of the treatment received
Time frame: 1, 3 and 6 months
Clinician Global Assessment of the treatment received
Time frame: 1, 3 and 6 months
Percentage of OMERACT-OARSI (Outcome Measure in Rheumatology - Osteoarthitis Research Society International) responders at 1, 3 and 6 Months
Time frame: 1, 3 and 6 months
Percentage of patients requiring an injection of the combination of PRP/HA prepared with Cellular Matrix / A-CP HA at 6 Months
Time frame: 6 months
Number of local and systemic side effects throughout the study period
Time frame: 6 months
Cartilage structure
Time frame: 6 months
Rescue treatment consumption at 1, 3 and 6 Months
Time frame: 1, 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2019.
- Individual participant dataSharing planned: Undecided
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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.
Philippe Adam, MD principal investigator
Clinique Médipôle Garonne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cellular Matrix / A-CP HA Kit and Synvisc-One in people with Knee Osteoarthritis, run by Regen Lab SA at 1 site in France.
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 29 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 14 Nov 2019. 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 France. 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.
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?
Change from Baseline pain on walking (Western Ontario & McMaster Universities [WOMAC] A1 of the WOMAC questionaire) at 6 months (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 14 Nov 2019.