NCT05660824

Brief 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 osteoarthritis.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for phase_4

Timeline
15mo left

Started Jul 2025

Typical duration for phase_4

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Jul 2025Aug 2027

First Submitted

Initial submission to the registry

January 24, 2022

Completed
11 months until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
2.5 years until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

April 3, 2025

Status Verified

March 1, 2025

Enrollment Period

2 years

First QC Date

January 24, 2022

Last Update Submit

March 30, 2025

Conditions

Osteoarthritis

Keywords

mesenchymal stem cellsstem cellsStromal Vascular FractionOsteoarthritis

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Secondary Outcomes (7)

  • VAS

    1, 2, 3, 6, and 12 months

  • WOMAC

    1, 2, 3, 6, and 12 months

  • Return to work

    1, 2, 3, 6, and 12 months

  • Return to sport

    1, 2, 3, 6, and 12 months

  • AMADEUS SCORE

    6 and 12 moths

  • +2 more secondary outcomes

Other Outcomes (10)

  • Age

    Baseline

  • Sex

    Baseline

  • Height

    Baseline

  • +7 more other outcomes

Study Arms (2)

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.

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.

Procedure: Plattelet Rich Plasma infiltration

Interventions

Stromal Vascular Fraction infiltrationDEVICE

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.

Also known as: Autologous conditionned adipose tissue (ACA) kit by Arthrex
SVF (Stromal vascular fraction)
Plattelet Rich Plasma infiltrationPROCEDURE

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

Also known as: Autologous conditionned plasma (ACP) kit by Arthrex
PRP (Platelet-rich plasma)

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Adrien SchwitzguĂ©bel, MD.

    HĂ´pital de La Providenc

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrien Schwitzguébel, MD.

CONTACT

+41 79 762 05 62adrien.schwitzguebel@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physician Director of Sports Medicine Department

Study Record Dates

First Submitted

January 24, 2022

First Posted

December 21, 2022

Study Start

July 1, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

April 3, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share