Osteo Arthritis KneePhase 2NCT04321629
Knee Arthritis Treatment With Autologous Fragmented Adipose Tissue and PRP - Comparison of Two Treatment Methods
A Phase 2 study testing autologous adipose tissue transfer and PRP injections in people with Osteo Arthritis Knee and Knee Osteoarthritis, run by Rehasport Clinic at 1 site in Poland.
Trial summary
This is a prospective, randomized, controlled study. The purpose of this study is to assess functional and clinical changes among patients with symptomatic knee OA treated with intra-articular injections of autologous adipose tissue or PRP and to compare the efficacy of both therapeutic methods. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Osteo Arthritis Knee, Knee Osteoarthritis, Knee Pain Chronic
- What is being tested?
- autologous adipose tissue transfer and PRP injections
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 30 Jul 2018to 31 Dec 2022
- Phase
- Phase 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- symptomatic knee OA
- Kellgren- Lawrence grades I - III OA
- no or minimal positive effects of previous conservative treatment (rehabilitation, hyaluronic acid injections, steroid injections)
- VAS pain level minimum 4 in one knee, VAS pain < 2 in the contralateral knee
Who cannot join
- Use of local corticosteroids up to three months or hyaluronic acid injections up to six months prior to the study
- Past or present joint infection
- Previous knee arthroscopy surgery up to one year prior to examination
- Peripheral inflammatory diseases (rheumatoid arthritis, spondyloarthropathies, etc.)
- Total arthroplasty and osteotomy
- Ankylosis of the joint
Show all 12Show fewer
- Dermatitis or dermatological disease at the intended injection site
- Coexistence of degenerative changes in other limb joints (hip, foot)
- Cancer
- Oral corticosteroid therapy
- Use of medicines that affect blood clotting
- Pregnancy or breast-feeding
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Rehasport
Poznan, Wielkopolska, 60201
Katarzyna Banaszek, Mrs, 0048616281181 ext. 152, katarzyna.banaszek@rehasport.pl
Paweł Bąkowski, MD
About this study
Official title: Autologous Adipose Tissue Injection Versus Platelet-rich Plasma (PRP) Injection in the Treatment of Knee Osteoarthritis: a Randomized, Controlled Study - Study Protocol
This is a prospective, randomized, controlled study. The purpose of this study is to assess functional and clinical changes among patients with symptomatic knee OA treated with intra-articular injections of autologous adipose tissue or PRP and to compare the efficacy of both therapeutic methods. We hypothesize that adipose tissue injections will improve patients' quality of life and functional status and will decrease pain level significantly more than PRP injections. In addition to the functional tests and muscle strength measurement, the patient reported outcome measures (PROMs) of the knee joint function and quality of life will be used to assess each participant.
The same inclusion criteria have been established for an Experimental Group (subjects treated with autologous fat tissue) and a Control Group (subjects treated with PRP). Those criteria consist of: symptomatic knee OA, age between 45 and 65 y.o., Kellgren- Lawrence grades I - III OA, no or minimal positive effects of previous conservative treatment (rehabilitation, hyaluronic acid injections, steroid injections). Those patients who meet inclusion criteria will be allocated to Fat Tissue Group or PRP Group randomly.
Read more
Patients will be assessed five times: before treatment and 1, 3, 6 and 12 months after the treatment. The PROMs consist of the four questionnaires: The Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee 2000 (IKDC 2000), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (21,22), the Health Questionnaire EQ- 5D- 5L.
Moreover, three functional tests will be performed to assess patient's functional status: The Timed Up and Go Test (TUG), The 5 Times Sit to Stand Test (5xSTS), The 10m Walk Test (10mWT). To assess strength parameters of the knee flexors and extensors the Maximal Voluntary Isometric Contraction (MVIC) will be measured. Each test will be supervised by the same one physiotherapist to avoid any interexaminer bias and discrepancies during testing.
Read the detailed description
This is a prospective, randomized, controlled study. The purpose of this study is to assess functional and clinical changes among patients with symptomatic knee OA treated with intra-articular injections of autologous adipose tissue or PRP and to compare the efficacy of both therapeutic methods.
Lipoaspiration procedure Lipoaspiration will take place in the operating room under general anesthesia for patient's and doctor's comfort. The most frequent donor site is abdomen (14,15). The patient will be placed in a supine position. At first, two small incisions at the level of umbilicus will be made by the trained orthopaedic surgeon (TP or PB). Then Klein solution (saline with lidocaine and epinephrine) will be infused to reduce bleeding. Ten minutes is required for infiltration. Next step is a liposuction performed with a thin cannula inserted through incisions. Finally, skin sutures and the pressure dressing will be applied. To minimize risk of bleeding and hematoma, an elastic belt will be recommended, as well as partial weight bearing within first two weeks. Harvested adipose tissue will be prepared in a Lipogems kit (14). The final product will be transferred into 10-ml syringes. About 10 ml of the product will be injected into the affected knee joint.
PRP procedure PRP preparation takes place in an outpatient clinic. 10-ml sterile collecting tubes containing citrate will be placed in a centrifuge (Centrifuge MPV- 223e) with a tilting rotor. Rotation will last 7 minutes at 2054 rounds per minute. After centrifugation, PRP will be collected up to 3 ml for separate 10-ml syringe. 3 ml of PRP will be injected into the knee joint. Procedure will be repeated three times in 7 day interval.
Injection procedure Joint injection will be performed by TP or PB in the same manner for both groups: patient placed in supine position, affected knee extended, a 21-Gauge needle inserted into the suprapatellar pouch, in case of joint effusion - aspiration of synovial fluid and finally administration of autologous fat tissue or PRP.
This study protocol has several strengths and weaknesses. Undoubtedly one of strongest point of this study is wide, multidimensional functional assessment, which will give a large amount of objective data. To our knowledge, this research is the first one which includes the battery of functional tests and MVIC as an outcome measurement tool. This study will use 4 questionnaires, including WOMAC, which is described by physicians as a gold standard for assessing the effectiveness of knee OA treatment (47,48).
On the other hand this study has several limitations. Primarily - the lack of blinding and we consider this as a risk of both, subject and investigator bias. Next and equally important limitation is a small size of the study. Furthermore, autologous fat tissue procedure is definitely more invasive and more stressful for the patients than PRP procedure. Hence, taking all into consideration, to adopt autologous fat tissue as a knee OA therapy, based on the future results, we have to detect definite, statistically significant and clinically noticeable difference.
Our PRP procedure gives us the possibility to examine the patient and assess the reaction to intra- articular injection 3 times (3 injections) in 7 day interval. These visits are often associated with physical therapy, which consists of manual therapy and individualized exercise program. Autologous fat tissue procedure does not give us such a possibility. The doctor and physiotherapist see the patient on the day of the surgery and two weeks after, during a control visit, which is also associated with physical therapy. Thus, there are some discrepancies between the two procedures at the beginning of the treatment process.
It has been proven that intra- articular injection of autologous fat tissue or PRP is a safety treatment option of knee OA (49,50). The most common complications after the intra- articular injection are pain and swelling of treated knee, but this improve after cold compression and NSAIDs. Also there were no cancer incidents reported after autologous fat tissue or PRP implantation(50).
Subject recruitment has started after we received Bioethical Committee approval.
- Conditions
- Osteo Arthritis Knee, Knee Osteoarthritis, Knee Pain Chronic, Knee Arthritis, Knee Disease, Knee Pain Swelling
- Being tested
- autologous adipose tissue transfer, PRP injections
- Keywords
- knee, arthritis, prp, msc, fat transfer, adipose tissue
- Medical subject headings
- Osteoarthritis, Knee, Joint Diseases, Arthritis, Insomnia, Fatal Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous adipose tissue transferCombination product
experimental group: liposuction, adipose tissue preparation and intra-articular injection
PRP injectionsCombination product
control group: blood collection, blood preparation and intra-articular PRP injection
| Study group | Role | What they receive |
|---|---|---|
| Autologous Fat Tissue Group | Experimental | Group of patients treated with intra-articular injections of autologous adipose tissue. Receives: Combination Product: autologous adipose tissue transfer |
| PRP Group | Active comparator | Group of patients treated with intra-articular injections of platelet-rich-plasma. Receives: Combination Product: PRP injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in The Knee injury and Osteoarthritis Outcome Score (KOOS)
The answers are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated.
Measured: 1, 3, 6 and 12 months after the treatment
Change in the International Knee Documentation Committee 2000 (IKDC 2000) score
The IKDC contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Measured: 1, 3, 6 and 12 months after the treatment
Change in tthe Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score
Due to no polish version of the WOMAC score, it will be calculated from KOOS score. Higher scores represent worse pain, stiffness, and functional limitations.
Measured: 1, 3, 6 and 12 months after the treatment
Change in the quality of life score (EQ- 5D- 5L)
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Scores range from 5 points (highest level of function and lowest level of symptoms) to 25 points (lowest level of function or highest level of symptoms).
Measured: 1, 3, 6 and 12 months after the treatment
Change in functional status according to The Timed Up and Go Test (TUG)
The result of this test is time measured with stopwatch. Time limit for this test is 3 minutes 30 seconds. Less time means better result.
Measured: 1, 3, 6 and 12 months after the treatment
Change in functional status according to The 5 Times Sit to Stand Test (5xSTS)
The result of this test is time measured with stopwatch. The stopwatch is stopped when the subject sits down after the fifth repetition. Less time means better result.
Measured: 1, 3, 6 and 12 months after the treatment
Change in functional status according to The 10m Walk Test (10mWT)
The result of this test is time measured with stopwatch. The patient is not allowed to run but may use the crutches or a walker if needed. Less time means better result.
Measured: 1, 3, 6 and 12 months after the treatment
Secondary outcomes (1)
Strength parameters
Strength parameters of the knee flexors and extensors the Maximal Voluntary Isometric Contraction (MVIC)
Measured: 1, 3, 6 and 12 months after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start30 Jul 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis KneeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rehasport Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pawel Bakowski, MD PhD, Principal investigator, Rehasport ClinicTomasz Piontek, MD PhD, Study chair, Rehasport Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321629
- Sponsor's protocol ID
- RSC_PBAK_2018_V3
- Status last verified
- Mar 2020
- First submitted
- 20 Mar 2020
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bakowski P, Kaszynski J, Walecka J, Ciemniewska-Gorzela K, Bakowska-Zywicka K, Piontek T. Autologous adipose tissue injection versus platelet-rich plasma (PRP) injection in the treatment of knee osteoarthritis: a randomized, controlled study - study protocol. BMC Musculoskelet Disord. 2020 May 20;21(1):314. doi: 10.1186/s12891-020-03345-8.
PubMed 32434498
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Adipose Tissue Injection Versus Platelet-rich Plasma (PRP) Injection in the Treatment of Knee Osteoarthritis: a Randomized, Controlled Study - Study Protocol
- ClinicalTrials.gov ID
- NCT04321629
- Acronym / sponsor ID
- RSC_PBAK_2018_V3
- Conditions
- Osteo Arthritis Knee, Knee Osteoarthritis, Knee Pain Chronic, Knee Arthritis, Knee Disease, Knee Pain Swelling
- Keywords
- knee, arthritis, prp, msc, fat transfer, adipose tissue
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rehasport ClinicUniversity, hospital or other
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 25 Mar 2020 (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 prospective, randomized, controlled study. The purpose of this study is to assess functional and clinical changes among patients with symptomatic knee OA treated with intra-articular injections of autologous adipose tissue or PRP and to compare the efficacy of both therapeutic methods. We hypothesize that adipose tissue injections will improve patients' quality of life and functional status and will decrease pain level significantly more than PRP injections. In addition to the functional tests and muscle strength measurement, the patient reported outcome measures (PROMs) of the knee joint function and quality of life will be used to assess each participant.
The same inclusion criteria have been established for an Experimental Group (subjects treated with autologous fat tissue) and a Control Group (subjects treated with PRP). Those criteria consist of: symptomatic knee OA, age between 45 and 65 y.o., Kellgren- Lawrence grades I - III OA, no or minimal positive effects of previous conservative treatment (rehabilitation, hyaluronic acid injections, steroid injections). Those patients who meet inclusion criteria will be allocated to Fat Tissue Group or PRP Group randomly.
Patients will be assessed five times: before treatment and 1, 3, 6 and 12 months after the treatment. The PROMs consist of the four questionnaires: The Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee 2000 (IKDC 2000), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (21,22), the Health Questionnaire EQ- 5D- 5L.
Moreover, three functional tests will be performed to assess patient's functional status: The Timed Up and Go Test (TUG), The 5 Times Sit to Stand Test (5xSTS), The 10m Walk Test (10mWT). To assess strength parameters of the knee flexors and extensors the Maximal Voluntary Isometric Contraction (MVIC) will be measured. Each test will be supervised by the same one physiotherapist to avoid any interexaminer bias and discrepancies during testing.
Detailed description
This is a prospective, randomized, controlled study. The purpose of this study is to assess functional and clinical changes among patients with symptomatic knee OA treated with intra-articular injections of autologous adipose tissue or PRP and to compare the efficacy of both therapeutic methods.
Lipoaspiration procedure Lipoaspiration will take place in the operating room under general anesthesia for patient's and doctor's comfort. The most frequent donor site is abdomen (14,15). The patient will be placed in a supine position. At first, two small incisions at the level of umbilicus will be made by the trained orthopaedic surgeon (TP or PB). Then Klein solution (saline with lidocaine and epinephrine) will be infused to reduce bleeding. Ten minutes is required for infiltration. Next step is a liposuction performed with a thin cannula inserted through incisions. Finally, skin sutures and the pressure dressing will be applied. To minimize risk of bleeding and hematoma, an elastic belt will be recommended, as well as partial weight bearing within first two weeks. Harvested adipose tissue will be prepared in a Lipogems kit (14). The final product will be transferred into 10-ml syringes. About 10 ml of the product will be injected into the affected knee joint.
PRP procedure PRP preparation takes place in an outpatient clinic. 10-ml sterile collecting tubes containing citrate will be placed in a centrifuge (Centrifuge MPV- 223e) with a tilting rotor. Rotation will last 7 minutes at 2054 rounds per minute. After centrifugation, PRP will be collected up to 3 ml for separate 10-ml syringe. 3 ml of PRP will be injected into the knee joint. Procedure will be repeated three times in 7 day interval.
Injection procedure Joint injection will be performed by TP or PB in the same manner for both groups: patient placed in supine position, affected knee extended, a 21-Gauge needle inserted into the suprapatellar pouch, in case of joint effusion - aspiration of synovial fluid and finally administration of autologous fat tissue or PRP.
This study protocol has several strengths and weaknesses. Undoubtedly one of strongest point of this study is wide, multidimensional functional assessment, which will give a large amount of objective data. To our knowledge, this research is the first one which includes the battery of functional tests and MVIC as an outcome measurement tool. This study will use 4 questionnaires, including WOMAC, which is described by physicians as a gold standard for assessing the effectiveness of knee OA treatment (47,48).
On the other hand this study has several limitations. Primarily - the lack of blinding and we consider this as a risk of both, subject and investigator bias. Next and equally important limitation is a small size of the study. Furthermore, autologous fat tissue procedure is definitely more invasive and more stressful for the patients than PRP procedure. Hence, taking all into consideration, to adopt autologous fat tissue as a knee OA therapy, based on the future results, we have to detect definite, statistically significant and clinically noticeable difference.
Our PRP procedure gives us the possibility to examine the patient and assess the reaction to intra- articular injection 3 times (3 injections) in 7 day interval. These visits are often associated with physical therapy, which consists of manual therapy and individualized exercise program. Autologous fat tissue procedure does not give us such a possibility. The doctor and physiotherapist see the patient on the day of the surgery and two weeks after, during a control visit, which is also associated with physical therapy. Thus, there are some discrepancies between the two procedures at the beginning of the treatment process.
It has been proven that intra- articular injection of autologous fat tissue or PRP is a safety treatment option of knee OA (49,50). The most common complications after the intra- articular injection are pain and swelling of treated knee, but this improve after cold compression and NSAIDs. Also there were no cancer incidents reported after autologous fat tissue or PRP implantation(50).
Subject recruitment has started after we received Bioethical Committee approval.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous Fat Tissue Group | Experimental | Combination Product: autologous adipose tissue transferGroup of patients treated with intra-articular injections of autologous adipose tissue. |
| PRP Group | Active comparator | Combination Product: PRP injectionsGroup of patients treated with intra-articular injections of platelet-rich-plasma. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- symptomatic knee OA
- Kellgren- Lawrence grades I - III OA
- no or minimal positive effects of previous conservative treatment (rehabilitation, hyaluronic acid injections, steroid injections)
- VAS pain level minimum 4 in one knee, VAS pain < 2 in the contralateral knee
Key exclusion criteria (12 listed)
- Use of local corticosteroids up to three months or hyaluronic acid injections up to six months prior to the study
- Past or present joint infection
- Previous knee arthroscopy surgery up to one year prior to examination
- Peripheral inflammatory diseases (rheumatoid arthritis, spondyloarthropathies, etc.)
- Total arthroplasty and osteotomy
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 |
|---|---|---|
| autologous adipose tissue transferexperimental group: liposuction, adipose tissue preparation and intra-articular injection | Combination product | Autologous Fat Tissue Group |
| PRP injectionscontrol group: blood collection, blood preparation and intra-articular PRP injection | Combination product | PRP Group |
Primary outcome
Change in The Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 1, 3, 6 and 12 months after the treatment
The answers are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated.
Change in the International Knee Documentation Committee 2000 (IKDC 2000) score
Time frame: 1, 3, 6 and 12 months after the treatment
The IKDC contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Change in tthe Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score
Time frame: 1, 3, 6 and 12 months after the treatment
Due to no polish version of the WOMAC score, it will be calculated from KOOS score. Higher scores represent worse pain, stiffness, and functional limitations.
Change in the quality of life score (EQ- 5D- 5L)
Time frame: 1, 3, 6 and 12 months after the treatment
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. Scores range from 5 points (highest level of function and lowest level of symptoms) to 25 points (lowest level of function or highest level of symptoms).
Change in functional status according to The Timed Up and Go Test (TUG)
Time frame: 1, 3, 6 and 12 months after the treatment
The result of this test is time measured with stopwatch. Time limit for this test is 3 minutes 30 seconds. Less time means better result.
Change in functional status according to The 5 Times Sit to Stand Test (5xSTS)
Time frame: 1, 3, 6 and 12 months after the treatment
The result of this test is time measured with stopwatch. The stopwatch is stopped when the subject sits down after the fifth repetition. Less time means better result.
Change in functional status according to The 10m Walk Test (10mWT)
Time frame: 1, 3, 6 and 12 months after the treatment
The result of this test is time measured with stopwatch. The patient is not allowed to run but may use the crutches or a walker if needed. Less time means better result.
1 secondary outcome
Strength parameters
Time frame: 1, 3, 6 and 12 months after the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Derived from this study: PubMed 32434498Bakowski P, Kaszynski J, Walecka J, Ciemniewska-Gorzela K, Bakowska-Zywicka K, Piontek T. Autologous adipose tissue injection versus platelet-rich plasma (PRP) injection in the treatment of knee osteoarthritis: a randomized, controlled study - study protocol. BMC Musculoskelet Disord. 2020 May 20;21(1):314. doi: 10.1186/s12891-020-03345-8.
- 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.
Pawel Bakowski, MD PhD principal investigator
Rehasport Clinic
Tomasz Piontek, MD PhD study chair
Rehasport Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing autologous adipose tissue transfer and PRP injections in people with Osteo Arthritis Knee and Knee Osteoarthritis, run by Rehasport Clinic at 1 site in Poland.
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 4 inclusion and 12 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 25 Mar 2020. 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 Poland. 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?
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?
Contact Pawel Bakowski, MD PhD (0048504759624, pawel.bakowski@o2.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in The Knee injury and Osteoarthritis Outcome Score (KOOS) (time frame: 1, 3, 6 and 12 months after the treatment). The study lists 7 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 NCT04321629, which also lists 1 linked publication.
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 25 Mar 2020.