OsteearthritisPhase 4NCT07405840
Application of Autologous Stem Cells From Adipose Tissue in the Regeneration of Knee Joint Cartilage
A Phase 4 study testing stromal vascular fraction (SVF) and CP in people with Osteearthritis, run by Clinical Center of Vojvodina at 1 site in Serbia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteearthritis
- What is being tested?
- stromal vascular fraction (SVF) and CP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSerbia
- Study dates
- 25 Jun 2025to 31 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Serbia1 site
University Clinical Center of Vojvodina
Novi Sad, Vojvodina, 21000
About this study
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.
Read the detailed description
Knee osteoarthritis (OA) is a progressive degenerative joint disorder characterized by cartilage loss, subchondral bone remodeling, synovial inflammation, and joint pain. It is a leading cause of disability worldwide, particularly affecting weight-bearing joints such as the knee. The pathological process involves a combination of mechanical stress, inflammatory cytokine activity, and abnormal tissue remodeling, leading to progressive cartilage degradation and functional impairment. OA is increasingly recognized as a biologically active disease rather than a simple "wear-and-tear" condition, with complex interactions among chondrocytes, synoviocytes, immune cells, and extracellular matrix components.
Current non-surgical therapies, including analgesics, physiotherapy, and chondroprotective agents, primarily address symptom control and functional preservation, without altering the underlying degenerative process. Surgical interventions, such as osteotomy or total knee arthroplasty, are reserved for advanced disease but are associated with risks and limited applicability in younger or active patients. These limitations have prompted the exploration of regenerative medicine approaches that aim to restore joint homeostasis and promote cartilage repair.
Autologous adipose-derived stromal vascular fraction (SVF) has emerged as a promising regenerative therapy for knee OA. SVF is a heterogeneous cell population derived from adipose tissue, comprising mesenchymal stem cells (MSCs), pericytes, endothelial progenitors, and other stromal cells. These cells possess anti-inflammatory, immunomodulatory, and trophic properties that can support tissue repair both directly and indirectly. SVF may contribute to cartilage regeneration through differentiation of MSCs into chondrocytes, secretion of growth factors and cytokines that stimulate resident chondrocytes, modulation of synovial inflammation, and promotion of angiogenesis in the subchondral bone. Compared to bone marrow-derived MSCs, adipose tissue provides a more abundant and easily accessible source of regenerative cells with minimal donor site morbidity.
Preclinical studies and early clinical trials have demonstrated that intra-articular injection of adipose-derived SVF is feasible, safe, and associated with improvements in pain, function, and cartilage quality. However, there is a paucity of controlled clinical data directly comparing SVF therapy with standard chondroprotective interventions, particularly in the Serbian population. The present study is designed to address this gap by systematically evaluating the clinical efficacy, safety, and regenerative potential of SVF in patients with moderate to severe knee OA.
This trial will employ rigorous, standardized methodologies for SVF isolation and administration, using a closed mechanical system to obtain a highly viable and potent cell population. By combining clinical assessments with imaging-based evaluation of cartilage repair, this study aims to generate comprehensive data on both symptomatic and structural outcomes. The results are expected to provide critical evidence to support the integration of SVF therapy into standard orthopedic practice, potentially offering a regenerative alternative for patients with degenerative knee disease.
- Conditions
- Osteearthritis
- Being tested
- stromal vascular fraction (SVF), CP
- Keywords
- osteoarthritis, stromal vascular fraction, chondroprotectors, regenerative orthopedic surgery
- 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 (SVF)Biological
Also called SVF
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| SVF group | Experimental | In this arm, we included patients which will be treated with intraarticular injection of SVF from fat pad Receives: 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 Receives: Drug: CP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 6 and 12 months post-treatment.
Secondary outcomes (6)
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description: The KOOS is a patient-reported questionnaire assessing knee-related pain, symptoms, function in daily living, function in sports and recreation, and knee-related quality of life. Scores range from 0 (extreme problems) to 100 (no problems).Purpose: To evaluate overall knee function and symptom improvement following SVF or chondroprotective therapy.
Measured: Baseline (pre-treatment) 3, 6 and 12 months post-intervention.
Lysholm Knee Scoring Scale
Description: The Lysholm score evaluates knee function based on symptoms such as limp, support, locking, instability, pain, swelling, stair climbing, and squatting. Scores range from 0 (worst function) to 100 (normal function).
Purpose: To quantify functional recovery and symptom improvement in daily activities.
Measured: Timepoints: Baseline, 3, 6 and 12 months post-treatment.
Visual Analog Scale (VAS) for Pain
Description: The VAS is a 100 mm scale where patients indicate their perceived pain intensity, from 0 (no pain) to 100 (worst possible pain).Purpose: To measure changes in subjective knee pain intensity over time.
Measured: Baseline, 3,6 and 12 months post-treatment.
MRI-based Cartilage Evaluation (MOCART Score)
Description: The Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score evaluates structural cartilage repair by assessing defect fill, integration to border zone, surface, structure, signal intensity, subchondral lamina, subchondral bone, adhesions, and synovitis. Scores range from 0 (worst repair) to 100 (optimal repair).
Purpose: To assess morphological cartilage regeneration following intervention.
Measured: Baseline and 12 months post-treatment.
Short Form Health Survey (SF-36)
Description: The SF-36 is a patient-reported survey evaluating health-related quality of life across eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional health, and mental health. Scores are transformed to a 0-100 scale, with higher scores indicating better health.
Purpose: To assess changes in overall health-related quality of life after treatment.
Measured: Baseline and 12 months post-treatment.
Documentation of Adverse Events
Description: All local or systemic adverse events, including injection site reactions, swelling, pain exacerbation, infection, or other unexpected clinical events, will be recorded and categorized according to severity, duration, and relationship to the study intervention.
Purpose: To evaluate the safety profile of SVF and standard chondroprotective therapies.
Measured: Throughout the 12-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start25 Jun 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteearthritisStudies 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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Center of Vojvodina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sasa Karan, Clinical Center of Vojvodina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07405840
- Sponsor's protocol ID
- 00-421/2024
- Status last verified
- Feb 2026
- First submitted
- 22 Jan 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Garza JR, Campbell RE, Tjoumakaris FP, Freedman KB, Miller LS, Santa Maria D, Tucker BS. 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 Mar;48(3):588-598. doi: 10.1177/0363546519899923.
PubMed 32109160
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Autologous Stem Cells From Adipose Tissue in the Regeneration of Knee Joint Cartilage
- ClinicalTrials.gov ID
- NCT07405840
- Acronym / sponsor ID
- 00-421/2024
- Conditions
- Osteearthritis
- Keywords
- osteoarthritis, stromal vascular fraction, chondroprotectors, regenerative orthopedic surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Clinical Center of VojvodinaUniversity, hospital or other
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Feb 2026 (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 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.
Detailed description
Knee osteoarthritis (OA) is a progressive degenerative joint disorder characterized by cartilage loss, subchondral bone remodeling, synovial inflammation, and joint pain. It is a leading cause of disability worldwide, particularly affecting weight-bearing joints such as the knee. The pathological process involves a combination of mechanical stress, inflammatory cytokine activity, and abnormal tissue remodeling, leading to progressive cartilage degradation and functional impairment. OA is increasingly recognized as a biologically active disease rather than a simple "wear-and-tear" condition, with complex interactions among chondrocytes, synoviocytes, immune cells, and extracellular matrix components.
Current non-surgical therapies, including analgesics, physiotherapy, and chondroprotective agents, primarily address symptom control and functional preservation, without altering the underlying degenerative process. Surgical interventions, such as osteotomy or total knee arthroplasty, are reserved for advanced disease but are associated with risks and limited applicability in younger or active patients. These limitations have prompted the exploration of regenerative medicine approaches that aim to restore joint homeostasis and promote cartilage repair.
Autologous adipose-derived stromal vascular fraction (SVF) has emerged as a promising regenerative therapy for knee OA. SVF is a heterogeneous cell population derived from adipose tissue, comprising mesenchymal stem cells (MSCs), pericytes, endothelial progenitors, and other stromal cells. These cells possess anti-inflammatory, immunomodulatory, and trophic properties that can support tissue repair both directly and indirectly. SVF may contribute to cartilage regeneration through differentiation of MSCs into chondrocytes, secretion of growth factors and cytokines that stimulate resident chondrocytes, modulation of synovial inflammation, and promotion of angiogenesis in the subchondral bone. Compared to bone marrow-derived MSCs, adipose tissue provides a more abundant and easily accessible source of regenerative cells with minimal donor site morbidity.
Preclinical studies and early clinical trials have demonstrated that intra-articular injection of adipose-derived SVF is feasible, safe, and associated with improvements in pain, function, and cartilage quality. However, there is a paucity of controlled clinical data directly comparing SVF therapy with standard chondroprotective interventions, particularly in the Serbian population. The present study is designed to address this gap by systematically evaluating the clinical efficacy, safety, and regenerative potential of SVF in patients with moderate to severe knee OA.
This trial will employ rigorous, standardized methodologies for SVF isolation and administration, using a closed mechanical system to obtain a highly viable and potent cell population. By combining clinical assessments with imaging-based evaluation of cartilage repair, this study aims to generate comprehensive data on both symptomatic and structural outcomes. The results are expected to provide critical evidence to support the integration of SVF therapy into standard orthopedic practice, potentially offering a regenerative alternative for patients with degenerative knee disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SVF group | Experimental | Biological: stromal vascular fraction (SVF)In this arm, we included patients which will be treated with intraarticular injection of SVF from fat pad |
| CP group | Active comparator | Drug: CPIn this arm we will included patient swhich will be treated with Reviscon Re cross HA injection by MV Pharm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
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 (SVF)Also: SVFParticipants 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. | Biological | SVF group |
| CPParticipants 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. | Drug | CP group |
Primary outcome
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Baseline, 3 6 and 12 months post-treatment.
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.
6 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline (pre-treatment) 3, 6 and 12 months post-intervention.
Lysholm Knee Scoring Scale
Time frame: Timepoints: Baseline, 3, 6 and 12 months post-treatment.
Visual Analog Scale (VAS) for Pain
Time frame: Baseline, 3,6 and 12 months post-treatment.
MRI-based Cartilage Evaluation (MOCART Score)
Time frame: Baseline and 12 months post-treatment.
Short Form Health Survey (SF-36)
Time frame: Baseline and 12 months post-treatment.
Documentation of Adverse Events
Time frame: Throughout the 12-month follow-up.
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 12 Feb 2026.
- Background: PubMed 32109160Garza JR, Campbell RE, Tjoumakaris FP, Freedman KB, Miller LS, Santa Maria D, Tucker BS. 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 Mar;48(3):588-598. doi: 10.1177/0363546519899923.
- Individual participant dataSharing planned: Yes
Related trials for Osteearthritis
Recruiting
Effects of Mobilized Balance Platform Exercises on Balance Parameters in Patients With Knee Osteoarthritis
Osteearthritis, Knee Arthritis, Osteoarthritis
Not yet recruiting
Tecar Therapy in Chronic Knee Osteoarthritis
Osteearthritis
Recruiting
Effects of Diagonal Proprioceptive Neuromuscular Facilitation Patterns on Pain and Functional Outcomes in Patients With Knee Osteoarthritis
Knee Osteoarthristis, Osteearthritis
Recruiting
Effect of Agar/Collagen-based Compounds on Osteoarticular Pain: Randomized Triple-blind Clinical Trial
Osteearthritis, Joint Damage
Not yet recruitingObservational study
Value of Adding T2 Mapping Routine MRI in Assessment of Knee Articular Cartilage Early Osteoarthritis
Osteearthritis, OA
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing stromal vascular fraction (SVF) and CP in people with Osteearthritis, run by Clinical Center of Vojvodina at 1 site in Serbia.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (time frame: Baseline, 3 6 and 12 months post-treatment.). 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 NCT07405840, which also lists 1 linked publication.
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 12 Feb 2026.