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.
NCT ID: NCT05660824
Last Updated: 2025-04-03
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
PHASE4
Total Enrollment
108 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-07-31
Study Completion Date
2027-08-31
Brief Summary
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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.
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Detailed Description
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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.
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
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Osteoarthritis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Investigators
Outcome Assessors
This study is triple-blinded concerning (i) the participants during the intervention and throughout the study duration, (ii) the outcome assessor, and (iii) the statistician. The investigator in charge of the injections will be unblinded and therefore will not be assigned to outcomes assessment.
Follow-up and outcome assessment will be identical for both arms.
Follow-up and outcome assessment will be identical for both arms.
Study Groups
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SVF (Stromal vascular fraction)
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.
Group Type
EXPERIMENTAL
Stromal Vascular Fraction infiltration
Intervention Type
DEVICE
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.
PRP (Platelet-rich plasma)
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.
Group Type
ACTIVE_COMPARATOR
Plattelet Rich Plasma infiltration
Intervention Type
PROCEDURE
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
Interventions
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Stromal Vascular Fraction infiltration
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.
Intervention Type
DEVICE
Plattelet Rich Plasma infiltration
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
Intervention Type
PROCEDURE
Other Intervention Names
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Autologous conditionned adipose tissue (ACA) kit by Arthrex
Autologous conditionned plasma (ACP) kit by Arthrex
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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
* 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.
* 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
* 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.
Minimum Eligible Age
16 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Adrien Schwitzguebel
OTHER
Sponsor Role
lead
Responsible Party
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Adrien Schwitzguebel
Physician Director of Sports Medicine Department
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Adrien Schwitzguébel, MD.
Role: PRINCIPAL_INVESTIGATOR
Hôpital de La Providenc
Central Contacts
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References
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DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
28.12.2024
Identifier Type: -
Identifier Source: org_study_id
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