OsteoarthritisPhase 4SPOSTNCT05660824
Effectiveness of Stromal Vascular Fraction (SVF) and Platelet -Rich Plasma (PRP) in Patients With Knee Osteoarthritis: Study Protocol for a Phase III, Prospective, Randomized, Controlled Multi-center Study.
A Phase 4 study testing Stromal Vascular Fraction infiltration and Plattelet Rich Plasma infiltration in people with Osteoarthritis, run by Adrien Schwitzguebel.
Trial summary
This multicenter, randomized, triple-blind, controlled trial, will enroll 108 patients who will block-randomized in a 1:1 ratio to either the intervention or control group. The main question to answer are the clinical efficacy of SVF as adjuvant therapy to PRP on functionality and tissue regeneration for knee… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Stromal Vascular Fraction infiltration and Plattelet Rich Plasma infiltration
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Age older than 16 years old,
- Symptomatic knee osteoarthritis confirmed by magnetic resonance imaging (MRI)
- Absence of free or displaced meniscal or cartilage fragments on the MRI of the affected knee
- Failure of first-line conservative management in the last 3 months including medical or infiltrative treatment, orthotics use, active rehabilitation plan, adaptation of sports and work habits.
Who cannot join
- Patient is familiar with the lipoaspiration process
- Significant disease of the contralateral member with a function evaluated with SANE score below 80%
- Microcristalline disease (i.e. gout, pseudogout),
- Active inflammatory rheumatic disorders,
- Need of regular anti-inflammatory treatment (either NSAIDs or corticosteroids),
- Allergy to local anesthetics or epinephrin
Show all 16Show fewer
- Bleeding disorders or current anticoagulation therapy
- Patients with decompensated renal failure, hepatic dysfunction, or severe pulmonary or cardiovascular disease,
- Patients with an immunocompromised status
- Women who are pregnant or intend to become pregnant during the study
- Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant,
- Known or suspected non-compliance, drug, or alcohol abuse
- Previous enrollment into the current study,
- Participation in another study with investigational drug or procedure within the 30 days preceding and during the present study
- Enrollment of the investigator, his/her family members, employees, and other dependent persons
- If a bilateral disease is present and both sides require either the experimental or the control intervention, only the most symptomatic side will be studied.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of Stromal Vascular Fraction (SVF) and Platelet -Rich Plasma (PRP) in Patients With Knee Osteoarthritis: Study Protocol for a Phase III, Prospective, Randomized, Controlled Multi-center Study : (SPOST Study)
This multicenter, randomized, triple-blind, controlled trial, will enroll 108 patients who will block-randomized in a 1:1 ratio to either the intervention or control group. The main question to answer are the clinical efficacy of SVF as adjuvant therapy to PRP on functionality and tissue regeneration for knee osteoarthritis.
Read the detailed description
Background:
Osteoarthritis, the most common joint disease, has a high social and individual impact and the development of therapeutic options is a public health priority. It's multifactorial etiology is still a source of active research
Most common conservative treatments for osteoarthritis treatment include painkillers, active physical therapies, orthotics, infiltrations of corticosteroids, hyaluronic acid (HA), and platelet-rich plasma (PRP).
PRP may be beneficial in osteoarthritis by interfering with catabolic and inflammatory events and by subsequently promoting anabolic responses. Activation of PRP releases biologically active components, including platelet-derived growth factor (PDGF), transforming growth factor-β (PGF-β), type I insulin-like growth factor (IGF-1) and vascular endothelial growth factor (VEGF). These proteins are responsible for a range of critical tissue healing roles such as chondrocyte and mesenchymal stem cells proliferation, bone and vessel remodelling, inflammatory modulation and collagen synthesis.
For osteoarthritis, an improvement of clinical outcomes has been found in several clinical trials, presumably associated with the chondroprotective effect of PRP. Nevertheless, an in-vivo effect on human cartilage regeneration is not yet demonstrated despite the numerous studies approaching the subject.
Preclinical models elucidated how injected Adipose Derived- Mesenchymal Stem Cells (AD-MSC) coordinate the cartilage regeneration process through paracrine mechanisms, producing cytokines and trophic bioactive factors that stimulate cellular proliferation, reduce inflammation, fibrosis, oxidative stress, and chondrocytes senescence.
Stromal Vascular Fraction (SVF), a product from specific adipose tissue processing, contains mesenchymal stem cells, endothelial precursor cells, T regulatory cells, macrophages, smooth muscle cells, pericytes and preadipocytes. SVF extraction and injection techniques have been recently used as an alternative to harvest AD-MSC due to its logistic simplicity and feasibility in clinical practice.
SVF injections produce a clinically significant effect on the treatment of knee osteoarthritis, and a possible improvement in cartilage quality.
This clinical trial aims to assess the clinical efficacy of SVF as adjuvant therapy to PRP on functionality and tissue regeneration on osteoarthritis.
- Conditions
- Osteoarthritis
- Being tested
- Stromal Vascular Fraction infiltration, Plattelet Rich Plasma infiltration
- Keywords
- mesenchymal stem cells, stem cells, Stromal Vascular Fraction, Osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stromal Vascular Fraction infiltrationDevice
Also called Autologous conditionned adipose tissue (ACA) kit by Arthrex
Procedure to prepare SVF: In the operations room and after aseptic technic, local anesthesia is applied in the liposuction incision site with lidocaine 1% without epinephrine subcutaneously. 60 ml of tumescent solution are injected. After 15-20 minutes waiting, 15 ml of lipoaspiration per side are recollected into a double syringe. This is centrifuged for 4 minutes at 2.500 rpm and the remaining fat is separated from the other fractions. Two 1.4 mm GEMS syringes are attached together, and fat is transferred at least 30 times from one syringe to the other. Syringe content is again centrifugated for 4 minutes. The oil is discarded and approximately 1.5ml SVF fraction remains.
Plattelet Rich Plasma infiltrationProcedure or surgery
Also called Autologous conditionned plasma (ACP) kit by Arthrex
Procedure to prepare PRP: 15 cm of peripheral blood obtained by venipuncture are centrifugated at 1500 RPM during 5 minutes. Using PRP Arthrex kit platelets poor plasma is discarded and 1-3 mm of PRP are ready to be injected
| Study group | Role | What they receive |
|---|---|---|
| SVF (Stromal vascular fraction) | Experimental | Patients will receive a venepuncture to obtain PRP, and a lipoaspirate to obtain SVF. Then an ultrasonographic guided PRP+SVF injection will be performed.
Patients will consecutively receive two monthly PRP injections. Receives: Device: Stromal Vascular Fraction infiltration |
| PRP (Platelet-rich plasma) | Active comparator | Patients will receive a venepuncture to obtain PRP, and a sham lipoaspirate. Then an ultrasonographic guided PRP injection will be performed.
Patients will consecutively receive two monthly PRP injections. Receives: Procedure: Plattelet Rich Plasma infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC
Functional improvement measured with the 0%-100% normalized Western Ontario McMaster Universities Osteoarthritis Index, where 0% indicates complete absence of symptoms and 100% indicates maximal possible symptoms severity
Measured: 6 months
Secondary outcomes (7)
VAS
The absolute difference (changes from baseline to other time points) in pain Visual Analogue Scale (VAS) during maximal physical activity performed by the patient, between the treatment and control arms on a 0 to 10 scale. 0: no pain, 10: maximal pain
Measured: 1, 2, 3, 6, and 12 months
WOMAC
The absolute difference (changes from baseline to other time points) between the treatment and control arms on the Western Ontario McMaster Universities Osteoarthritis Index on knee osteoarthritis cases. From 0 to 100, being 0: no limitation, 100: extreme limitation
Measured: 1, 2, 3, 6, and 12 months
Return to work
The absolute difference between the treatment and control arms on length of time to return work in days
Measured: 1, 2, 3, 6, and 12 months
Return to sport
The absolute difference between the treatment and control arms on length of time to return to sports in days
Measured: 1, 2, 3, 6, and 12 months
AMADEUS SCORE
The absolute difference (changes from baseline to other time points) between the treatment and control arms on Affected cartilage quality on MRI using Area Measurement And Depth Underlying Structures (AMADEUS) score. (0 worst, 100 best)
Measured: 6 and 12 moths
WORMS
The absolute difference (changes from baseline to other time points) between the treatment and control arms on Whole-Organ Magnetic Resonance Imaging Score score. (0 normal structure, 332 most severe grade).
Measured: 6 Months, 12 months
MOCART
The absolute difference (changes from baseline to other time points) between the treatment and control arms on Magnetic Resonance Observation of Cartilage Repair Tissue score. (0 = poor cartilage repair, 100 complete and normal cartilage repair)
Measured: 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study startJul 2025 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (113)Papers the sponsor has linked to this study.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentric randomized. Randomization will be performed at a 1:1 ratio to either the intervention arm or the active comparator. Each block of 4 patients will be assigned to specific strata according to age (over or under 40), presence of either partial, full cartilage defects or full cartilage defects with bone deformation.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adrien Schwitzguebel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Adrien Schwitzguebel, Hôpital de la Providence, Switzerland
- Investigators
- Adrien Schwitzguébel, MD., Principal investigator, Hôpital de La Providenc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660824
- Sponsor's protocol ID
- 28.12.2024
- Acronym
- SPOST
- Status last verified
- Mar 2025
- First submitted
- 24 Jan 2022
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
World Medical A. WMA declaration of Helsinki : ethical principles for medical research involving human subjects 2013. First edition. ed. Guildford, Surrey: Canary Publications; 2014. 12 pages p.
Harmonization ICo. Guideline for Good Clinical Practice. 1996.
McCormack J, Underwood F, Slaven E, Cappaert T. THE MINIMUM CLINICALLY IMPORTANT DIFFERENCE ON THE VISA-A AND LEFS FOR PATIENTS WITH INSERTIONAL ACHILLES TENDINOPATHY. Int J Sports Phys Ther. 2015 Oct;10(5):639-44.
PubMed 26491614Franchignoni F, Vercelli S, Giordano A, Sartorio F, Bravini E, Ferriero G. Minimal clinically important difference of the disabilities of the arm, shoulder and hand outcome measure (DASH) and its shortened version (QuickDASH). J Orthop Sports Phys Ther. 2014 Jan;44(1):30-9. doi: 10.2519/jospt.2014.4893. Epub 2013 Oct 30.
PubMed 24175606Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA. 2000 May 24-31;283(20):2701-11. doi: 10.1001/jama.283.20.2701.
PubMed 10819955Agarwal N, Mak C, Bojanic C, To K, Khan W. Meta-Analysis of Adipose Tissue Derived Cell-Based Therapy for the Treatment of Knee Osteoarthritis. Cells. 2021 Jun 1;10(6):1365. doi: 10.3390/cells10061365.
PubMed 34206010Ma W, Liu C, Wang S, Xu H, Sun H, Fan X. Efficacy and safety of intra-articular injection of mesenchymal stem cells in the treatment of knee osteoarthritis: A systematic review and meta-analysis. Medicine (Baltimore). 2020 Dec 4;99(49):e23343. doi: 10.1097/MD.0000000000023343.
PubMed 33285713Zhao D, Pan JK, Yang WY, Han YH, Zeng LF, Liang GH, Liu J. Intra-Articular Injections of Platelet-Rich Plasma, Adipose Mesenchymal Stem Cells, and Bone Marrow Mesenchymal Stem Cells Associated With Better Outcomes Than Hyaluronic Acid and Saline in Knee Osteoarthritis: A Systematic Review and Network Meta-analysis. Arthroscopy. 2021 Jul;37(7):2298-2314.e10. doi: 10.1016/j.arthro.2021.02.045. Epub 2021 Mar 10.
PubMed 33713757Jiang P, Mao L, Qiao L, Lei X, Zheng Q, Li D. Efficacy and safety of mesenchymal stem cell injections for patients with osteoarthritis: a meta-analysis and review of RCTs. Arch Orthop Trauma Surg. 2021 Jul;141(7):1241-1251. doi: 10.1007/s00402-020-03703-0. Epub 2021 Jan 28.
PubMed 33507375Dai W, Leng X, Wang J, Shi Z, Cheng J, Hu X, Ao Y. Intra-Articular Mesenchymal Stromal Cell Injections Are No Different From Placebo in the Treatment of Knee Osteoarthritis: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Arthroscopy. 2021 Jan;37(1):340-358. doi: 10.1016/j.arthro.2020.10.016. Epub 2020 Oct 21.
PubMed 33098949Lee SY, Kim W, Lim C, Chung SG. Treatment of Lateral Epicondylosis by Using Allogeneic Adipose-Derived Mesenchymal Stem Cells: A Pilot Study. Stem Cells. 2015 Oct;33(10):2995-3005. doi: 10.1002/stem.2110. Epub 2015 Aug 6.
PubMed 26202898Usuelli FG, Grassi M, Maccario C, Vigano' M, Lanfranchi L, Alfieri Montrasio U, de Girolamo L. Intratendinous adipose-derived stromal vascular fraction (SVF) injection provides a safe, efficacious treatment for Achilles tendinopathy: results of a randomized controlled clinical trial at a 6-month follow-up. Knee Surg Sports Traumatol Arthrosc. 2018 Jul;26(7):2000-2010. doi: 10.1007/s00167-017-4479-9. Epub 2017 Mar 1.
PubMed 28251260Stein BE, Stroh DA, Schon LC. Outcomes of acute Achilles tendon rupture repair with bone marrow aspirate concentrate augmentation. Int Orthop. 2015 May;39(5):901-5. doi: 10.1007/s00264-015-2725-7. Epub 2015 Mar 22.
PubMed 25795246Kim YS, Sung CH, Chung SH, Kwak SJ, Koh YG. Does an Injection of Adipose-Derived Mesenchymal Stem Cells Loaded in Fibrin Glue Influence Rotator Cuff Repair Outcomes? A Clinical and Magnetic Resonance Imaging Study. Am J Sports Med. 2017 Jul;45(9):2010-2018. doi: 10.1177/0363546517702863. Epub 2017 Apr 27.
PubMed 28448728Michalek J, Vrablikova A, Darinskas A, Lukac L, Prucha J, Skopalik J, Travnik J, Cibulka M, Dudasova Z. Stromal vascular fraction cell therapy for osteoarthritis in elderly: Multicenter case-control study. J Clin Orthop Trauma. 2019 Jan-Feb;10(1):76-80. doi: 10.1016/j.jcot.2018.11.010. Epub 2018 Nov 23. No abstract available.
PubMed 30705536
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Stromal Vascular Fraction (SVF) and Platelet -Rich Plasma (PRP) in Patients With Knee Osteoarthritis: Study Protocol for a Phase III, Prospective, Randomized, Controlled Multi-center Study : (SPOST Study)
- ClinicalTrials.gov ID
- NCT05660824
- Acronym / sponsor ID
- SPOST / 28.12.2024
- Conditions
- Osteoarthritis
- Keywords
- mesenchymal stem cells, stem cells, Stromal Vascular Fraction, Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Adrien SchwitzguebelUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 21 Dec 2022 (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 multicenter, randomized, triple-blind, controlled trial, will enroll 108 patients who will block-randomized in a 1:1 ratio to either the intervention or control group. The main question to answer are the clinical efficacy of SVF as adjuvant therapy to PRP on functionality and tissue regeneration for knee osteoarthritis.
Detailed description
Background:
Osteoarthritis, the most common joint disease, has a high social and individual impact and the development of therapeutic options is a public health priority. It's multifactorial etiology is still a source of active research
Most common conservative treatments for osteoarthritis treatment include painkillers, active physical therapies, orthotics, infiltrations of corticosteroids, hyaluronic acid (HA), and platelet-rich plasma (PRP).
PRP may be beneficial in osteoarthritis by interfering with catabolic and inflammatory events and by subsequently promoting anabolic responses. Activation of PRP releases biologically active components, including platelet-derived growth factor (PDGF), transforming growth factor-β (PGF-β), type I insulin-like growth factor (IGF-1) and vascular endothelial growth factor (VEGF). These proteins are responsible for a range of critical tissue healing roles such as chondrocyte and mesenchymal stem cells proliferation, bone and vessel remodelling, inflammatory modulation and collagen synthesis.
For osteoarthritis, an improvement of clinical outcomes has been found in several clinical trials, presumably associated with the chondroprotective effect of PRP. Nevertheless, an in-vivo effect on human cartilage regeneration is not yet demonstrated despite the numerous studies approaching the subject.
Preclinical models elucidated how injected Adipose Derived- Mesenchymal Stem Cells (AD-MSC) coordinate the cartilage regeneration process through paracrine mechanisms, producing cytokines and trophic bioactive factors that stimulate cellular proliferation, reduce inflammation, fibrosis, oxidative stress, and chondrocytes senescence.
Stromal Vascular Fraction (SVF), a product from specific adipose tissue processing, contains mesenchymal stem cells, endothelial precursor cells, T regulatory cells, macrophages, smooth muscle cells, pericytes and preadipocytes. SVF extraction and injection techniques have been recently used as an alternative to harvest AD-MSC due to its logistic simplicity and feasibility in clinical practice.
SVF injections produce a clinically significant effect on the treatment of knee osteoarthritis, and a possible improvement in cartilage quality.
This clinical trial aims to assess the clinical efficacy of SVF as adjuvant therapy to PRP on functionality and tissue regeneration on osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicentric randomized. Randomization will be performed at a 1:1 ratio to either the intervention arm or the active comparator. Each block of 4 patients will be assigned to specific strata according to age (over or under 40), presence of either partial, full cartilage defects or full cartilage defects with bone deformation.
| Arm | Type | Receives |
|---|---|---|
| SVF (Stromal vascular fraction) | Experimental | Device: Stromal Vascular Fraction infiltrationPatients will receive a venepuncture to obtain PRP, and a lipoaspirate to obtain SVF. Then an ultrasonographic guided PRP+SVF injection will be performed. Patients will consecutively receive two monthly PRP injections. |
| PRP (Platelet-rich plasma) | Active comparator | Procedure: Plattelet Rich Plasma infiltrationPatients will receive a venepuncture to obtain PRP, and a sham lipoaspirate. Then an ultrasonographic guided PRP injection will be performed. Patients will consecutively receive two monthly PRP injections. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Age older than 16 years old,
- Symptomatic knee osteoarthritis confirmed by magnetic resonance imaging (MRI)
- Absence of free or displaced meniscal or cartilage fragments on the MRI of the affected knee
- Failure of first-line conservative management in the last 3 months including medical or infiltrative treatment, orthotics use, active rehabilitation plan, adaptation of sports and work habits.
Key exclusion criteria (16 listed)
- Patient is familiar with the lipoaspiration process
- Significant disease of the contralateral member with a function evaluated with SANE score below 80%
- Microcristalline disease (i.e. gout, pseudogout),
- Active inflammatory rheumatic disorders,
- Need of regular anti-inflammatory treatment (either NSAIDs or corticosteroids),
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 |
|---|---|---|
| Stromal Vascular Fraction infiltrationAlso: Autologous conditionned adipose tissue (ACA) kit by ArthrexProcedure to prepare SVF: In the operations room and after aseptic technic, local anesthesia is applied in the liposuction incision site with lidocaine 1% without epinephrine subcutaneously. 60 ml of tumescent solution are injected. After 15-20 minutes waiting, 15 ml of lipoaspiration per side are recollected into a double syringe. This is centrifuged for 4 minutes at 2.500 rpm and the remaining fat is separated from the other fractions. Two 1.4 mm GEMS syringes are attached together, and fat is transferred at least 30 times from one syringe to the other. Syringe content is again centrifugated for 4 minutes. The oil is discarded and approximately 1.5ml SVF fraction remains. | Device | SVF (Stromal vascular fraction) |
| Plattelet Rich Plasma infiltrationAlso: Autologous conditionned plasma (ACP) kit by ArthrexProcedure to prepare PRP: 15 cm of peripheral blood obtained by venipuncture are centrifugated at 1500 RPM during 5 minutes. Using PRP Arthrex kit platelets poor plasma is discarded and 1-3 mm of PRP are ready to be injected | Procedure or surgery | PRP (Platelet-rich plasma) |
Primary outcome
WOMAC
Time frame: 6 months
Functional improvement measured with the 0%-100% normalized Western Ontario McMaster Universities Osteoarthritis Index, where 0% indicates complete absence of symptoms and 100% indicates maximal possible symptoms severity
7 secondary outcomes
VAS
Time frame: 1, 2, 3, 6, and 12 months
WOMAC
Time frame: 1, 2, 3, 6, and 12 months
Return to work
Time frame: 1, 2, 3, 6, and 12 months
Return to sport
Time frame: 1, 2, 3, 6, and 12 months
AMADEUS SCORE
Time frame: 6 and 12 moths
WORMS
Time frame: 6 Months, 12 months
MOCART
Time frame: 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- BackgroundWorld Medical A. WMA declaration of Helsinki : ethical principles for medical research involving human subjects 2013. First edition. ed. Guildford, Surrey: Canary Publications; 2014. 12 pages p.
- BackgroundHarmonization ICo. Guideline for Good Clinical Practice. 1996.
- Background: PubMed 26491614McCormack J, Underwood F, Slaven E, Cappaert T. THE MINIMUM CLINICALLY IMPORTANT DIFFERENCE ON THE VISA-A AND LEFS FOR PATIENTS WITH INSERTIONAL ACHILLES TENDINOPATHY. Int J Sports Phys Ther. 2015 Oct;10(5):639-44.
- Background: PubMed 24175606Franchignoni F, Vercelli S, Giordano A, Sartorio F, Bravini E, Ferriero G. Minimal clinically important difference of the disabilities of the arm, shoulder and hand outcome measure (DASH) and its shortened version (QuickDASH). J Orthop Sports Phys Ther. 2014 Jan;44(1):30-9. doi: 10.2519/jospt.2014.4893. Epub 2013 Oct 30.
- Background: PubMed 10819955Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA. 2000 May 24-31;283(20):2701-11. doi: 10.1001/jama.283.20.2701.
- Background: PubMed 34206010Agarwal N, Mak C, Bojanic C, To K, Khan W. Meta-Analysis of Adipose Tissue Derived Cell-Based Therapy for the Treatment of Knee Osteoarthritis. Cells. 2021 Jun 1;10(6):1365. doi: 10.3390/cells10061365.
- Background: PubMed 33285713Ma W, Liu C, Wang S, Xu H, Sun H, Fan X. Efficacy and safety of intra-articular injection of mesenchymal stem cells in the treatment of knee osteoarthritis: A systematic review and meta-analysis. Medicine (Baltimore). 2020 Dec 4;99(49):e23343. doi: 10.1097/MD.0000000000023343.
- Background: PubMed 33713757Zhao D, Pan JK, Yang WY, Han YH, Zeng LF, Liang GH, Liu J. Intra-Articular Injections of Platelet-Rich Plasma, Adipose Mesenchymal Stem Cells, and Bone Marrow Mesenchymal Stem Cells Associated With Better Outcomes Than Hyaluronic Acid and Saline in Knee Osteoarthritis: A Systematic Review and Network Meta-analysis. Arthroscopy. 2021 Jul;37(7):2298-2314.e10. doi: 10.1016/j.arthro.2021.02.045. Epub 2021 Mar 10.
- Background: PubMed 33507375Jiang P, Mao L, Qiao L, Lei X, Zheng Q, Li D. Efficacy and safety of mesenchymal stem cell injections for patients with osteoarthritis: a meta-analysis and review of RCTs. Arch Orthop Trauma Surg. 2021 Jul;141(7):1241-1251. doi: 10.1007/s00402-020-03703-0. Epub 2021 Jan 28.
- Background: PubMed 33098949Dai W, Leng X, Wang J, Shi Z, Cheng J, Hu X, Ao Y. Intra-Articular Mesenchymal Stromal Cell Injections Are No Different From Placebo in the Treatment of Knee Osteoarthritis: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Arthroscopy. 2021 Jan;37(1):340-358. doi: 10.1016/j.arthro.2020.10.016. Epub 2020 Oct 21.
- Background: PubMed 26202898Lee SY, Kim W, Lim C, Chung SG. Treatment of Lateral Epicondylosis by Using Allogeneic Adipose-Derived Mesenchymal Stem Cells: A Pilot Study. Stem Cells. 2015 Oct;33(10):2995-3005. doi: 10.1002/stem.2110. Epub 2015 Aug 6.
- Background: PubMed 28251260Usuelli FG, Grassi M, Maccario C, Vigano' M, Lanfranchi L, Alfieri Montrasio U, de Girolamo L. Intratendinous adipose-derived stromal vascular fraction (SVF) injection provides a safe, efficacious treatment for Achilles tendinopathy: results of a randomized controlled clinical trial at a 6-month follow-up. Knee Surg Sports Traumatol Arthrosc. 2018 Jul;26(7):2000-2010. doi: 10.1007/s00167-017-4479-9. Epub 2017 Mar 1.
- 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.
Adrien Schwitzguébel, MD. principal investigator
Hôpital de La Providenc
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Stromal Vascular Fraction infiltration and Plattelet Rich Plasma infiltration in people with Osteoarthritis, run by Adrien Schwitzguebel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 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: opening soon, as of the sponsor's last update on 3 Apr 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adrien Schwitzguébel, MD. (+41 79 762 05 62, adrien.schwitzguebel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC (time frame: 6 months). 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 NCT05660824, which also lists 113 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.