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)

March 30, 2025 updated by: Adrien Schwitzguebel

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.

Study Overview

Status

Not yet recruiting

Conditions

Osteoarthritis

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

108

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Adrien Schwitzguébel, MD.
Phone Number: +41 79 762 05 62
Email: adrien.schwitzguebel@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Description

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Triple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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. Other Names: Autologous conditionned adipose tissue (ACA) kit by Arthrex
Active Comparator: 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.	Procedure: 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 Other Names: Autologous conditionned plasma (ACP) kit by Arthrex

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: 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.

Other Names:

Autologous conditionned adipose tissue (ACA) kit by Arthrex

Active Comparator: 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.

Procedure: 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

Other Names:

Autologous conditionned plasma (ACP) kit by Arthrex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AMADEUS SCORE Time Frame: 6 and 12 moths	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)	6 and 12 moths
VAS Time Frame: 1, 2, 3, 6, and 12 months	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	1, 2, 3, 6, and 12 months
WOMAC Time Frame: 1, 2, 3, 6, and 12 months	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	1, 2, 3, 6, and 12 months
Return to work Time Frame: 1, 2, 3, 6, and 12 months	The absolute difference between the treatment and control arms on length of time to return work in days	1, 2, 3, 6, and 12 months
Return to sport Time Frame: 1, 2, 3, 6, and 12 months	The absolute difference between the treatment and control arms on length of time to return to sports in days	1, 2, 3, 6, and 12 months
WORMS Time Frame: 6 Months, 12 months	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).	6 Months, 12 months
MOCART Time Frame: 6 months, 12 months	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)	6 months, 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age Time Frame: Baseline	Age	Baseline
BMI Time Frame: Baseline	BMI	Baseline
Sex Time Frame: Baseline	Sex	Baseline
Height Time Frame: Baseline	Height, cm	Baseline
Weight Time Frame: Baseline	Weight, kg	Baseline
Number of patients with tobacco use Time Frame: Baseline	Number of patients with tobacco use	Baseline
Number of Participants with concomitant diseases Time Frame: Baseline	Number of Participants with concomitant diseases (diabetes Miletus, dyslipidemia, arterial hypertension, osteopenia, osteoporosis, presence of rheumatologic disease, renal failure, and other relevant comorbidity)	Baseline
Numer of current and previous treatments Time Frame: Baseline	Number of current and previous treatments for osteoarthritis and tendinopathy	Baseline
Kellgren-Lawrence Time Frame: Baseline	Baseline Kellgren-Lawrence grade in case of osteoarthritis. I: Mild to IV: Severe	Baseline
Number of patients with post-traumatic osteoarthritis Time Frame: Baseline	Number of patients with post-traumatic osteoarthritis	Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adrien Schwitzguebel

Investigators

Principal Investigator: Adrien Schwitzguébel, MD., Hôpital de La Providenc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

January 24, 2022

First Submitted That Met QC Criteria

December 14, 2022

First Posted (Actual)

December 21, 2022

Study Record Updates

Last Update Posted (Actual)

April 3, 2025

Last Update Submitted That Met QC Criteria

March 30, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

28.12.2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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)