NCT07405840

Brief Summary

This randomized, controlled clinical trial will evaluate the safety and effectiveness of autologous adipose-derived stromal vascular fraction (SVF) therapy in patients with knee osteoarthritis (OA) grades II-IV, compared with standard chondroprotective (CP) treatment. The study will enroll male and female patients and follow them for 12 months, assessing pain (VAS), function (WOMAC, KOOS, SF-36), radiologic progression, and safety (adverse events). The trial aims to determine whether SVF therapy provides superior clinical outcomes and to inform evidence-based recommendations for OA management in the Serbian population.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
20mo left

Started Jun 2025

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
active not 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 Progress34%
Jun 2025Dec 2027

Study Start

First participant enrolled

June 25, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

1.2 years

First QC Date

January 22, 2026

Last Update Submit

February 5, 2026

Conditions

Osteearthritis

Keywords

osteoarthritisstromal vascular fractionchondroprotectorsregenerative orthopedic surgery

Outcome Measures

Primary Outcomes (1)

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Description: The WOMAC is a validated self-administered questionnaire measuring pain, stiffness, and physical function in patients with knee osteoarthritis. Each subscale is scored, with higher scores indicating greater disability. Purpose: To assess changes in pain, joint stiffness, and functional impairment over time.

    Baseline, 3 6 and 12 months post-treatment.

Secondary Outcomes (6)

  • Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Baseline (pre-treatment) 3, 6 and 12 months post-intervention.

  • Lysholm Knee Scoring Scale

    Timepoints: Baseline, 3, 6 and 12 months post-treatment.

  • Visual Analog Scale (VAS) for Pain

    Baseline, 3,6 and 12 months post-treatment.

  • MRI-based Cartilage Evaluation (MOCART Score)

    Baseline and 12 months post-treatment.

  • Short Form Health Survey (SF-36)

    Baseline and 12 months post-treatment.

  • +1 more secondary outcomes

Study Arms (2)

SVF group

EXPERIMENTAL

In this arm, we included patients which will be treated with intraarticular injection of SVF from fat pad

Biological: stromal vascular fraction (SVF)

CP group

ACTIVE COMPARATOR

In this arm we will included patient swhich will be treated with Reviscon Re cross HA injection by MV Pharm

Drug: CP

Interventions

stromal vascular fraction (SVF)BIOLOGICAL

Participants will undergo autologous adipose tissue harvesting under local anesthesia. The adipose tissue (1-5 mL) will be processed using the Lipocube® mechanical closed system to isolate stromal vascular fraction (SVF), containing adipose-derived stem cells (ADSCs), pericytes, and regenerative stromal cells. The prepared SVF will be injected intra-articularly into the affected knee under sterile conditions.

Also known as: SVF
SVF group
CPDRUG

Participants will receive a single intra-articular injection of high-molecular-weight hyaluronic acid (Reviscon Re-Cross, MV Pharm; 88 mg sodium hyaluronate \[2.2%\] in 4 mL solution) under sterile conditions.

CP group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (≥18 years).
  • Radiologically confirmed knee OA (grades II-IV, Kellgren-Lawrence scale).
  • KOOS pain score ≤ 60 points.
  • Symptomatic degenerative knee disease with at least 6 months of persistent pain.
  • No history of major knee trauma or prolonged immobilization (\>10 days)

You may not qualify if:

  • Minors (\<18 years).
  • Asymptomatic OA (KL grade 0-I).
  • Severe axial deformity (varus \>10°, valgus \>10°).
  • Current anticoagulant or antiplatelet therapy.
  • Intra-articular corticosteroid injection within the past 6 months.
  • History of major knee trauma or surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinical Center of Vojvodina

Novi Sad, Vojvodina, 21000, Serbia

Location

Related Publications (1)

  • Garza JR, et al. Clinical efficacy of intra-articular mesenchymal stromal cells for the treatment of knee osteoarthritis: a double-blinded prospective randomized controlled clinical trial. Am J Sports Med. 2020;48(3):588-98.

    BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sasa Karan, MD, Orthopedic surgeon and Traumatologist

Study Record Dates

First Submitted

January 22, 2026

First Posted

February 12, 2026

Study Start

June 25, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations

SE(1)