Knee Chondral LesionPhase 4NCT07255547
PRP vs AD-SVF in Addition to Marrow Stimulation for Knee Chondral Lesion
A Phase 4 study testing Bone Marrow Stimulation, stromal vascular fraction (SVF) and PRP injection in people with Knee Chondral Lesion, run by Università degli Studi dell'Aquila at 1 site in Italy.
Trial summary
The goal of this clinical trial is to learn if PRP and adipose-derived stem cells (AD-SVF) enhance healing after knee microfracture for chondral lesions. It will also learn about the safety of the procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Chondral Lesion
- What is being tested?
- Bone Marrow Stimulation, stromal vascular fraction (SVF) and PRP injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2019to May 2026
- 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
- knee pain and functional limitation for at least three months, monocompartmental chondral lesion < 2 cm2, age over 18, and BMI between 18.5 and 30
Who cannot join
- previous major surgery on the same knee, concomitant chondral lesions in other knee compartments, being diagnosed with knee or hip osteoarthritis, knee instability, flexion deficit > 20° or extension deficit >15°, genu valgum or genu varum > 20°, patients with Hb values < 11 g/dL or platelet < 150000/µL, patients in therapy with antiaggregants or anticoagulants or immunosuppressive agents, pregnancy, and the following comorbidities: hematological/neurologic/metabolic/rheumatic diseases, neoplastic disorders or history of local infections.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arthrosocpic Treatment of Knee Chondral Lesions: Clinical, MRI and Histologic Comparison Between the Use of PRP vs ADSCs in Addition to Marrow Stimulation Techniques
The goal of this clinical trial is to learn if PRP and adipose-derived stem cells (AD-SVF) enhance healing after knee microfracture for chondral lesions. It will also learn about the safety of the procedure. The main questions it aims to answer are:
Do PRP and AD-SVF get better results than PRP alone in patients undergoing arthroscopic microfracture for knee monocompartmental cartilage injuries? What medical problems do participants have when taking drug ABC? Researchers will compare PRP + AD-SVF to PRP alone to see if PRP + AD-SVF work better to treat knee cartilage injuries.
Read more
Participants will:
Undergo knee microfracture and biologics injections at the end of the arthroscopic procedure (PRP+AD-SVF vs PRP).
Visit the clinic for checkups and tests at baseline and at 3, 6, 12 months post-treatment, and then annually.
- Conditions
- Knee Chondral Lesion
- Being tested
- Bone Marrow Stimulation, stromal vascular fraction (SVF), PRP injection
- Keywords
- PRP, AD-SVF, knee arthroscopy, cartilage, adipose tissue, microfracture, stromal vascular fraction
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Marrow StimulationProcedure or surgery
Also called knee arthroscopy, Steadman microfracture
All patients underwent an arthroscopic procedure (that further confirmed the preoperative diagnosis; i.e. monocompartmental chondral lesion - Outerbridge grade IV) including a concomitant bone marrow stimulation technique (microfracture). According to the technique described by Steadman, the cartilaginous lesion underwent preliminary debridement to remove the damaged cartilage and form a stable edge of healthy tissue and subsequent microfracture with an arthroscopic pick to stimulate the subchondral unit regenerative response.
stromal vascular fraction (SVF)Combination product
Also called PRP injection
After bone marrow stimulation technique, patients were randomly assigned to one of the two treatment arms (allocation ratio 1:1). 40 patients underwent PRP injection while the other 40 underwent PRP + AD-SVF injections.
PRP injectionDrug
After bone marrow stimulation technique, patients were randomly assigned to one of the two treatment arms (allocation ratio 1:1). 40 patients underwent PRP injection while the other 40 underwent PRP + AD-SVF injections.
| Study group | Role | What they receive |
|---|---|---|
| PRP | Active comparator | In this arm, patients undergo arthroscopic microfracture of the chondral lesion and PRP injection. Receives: Procedure: Bone Marrow Stimulation; Drug: PRP injection |
| PRP + AD-SVF | Experimental | In this arm, patients undergo arthroscopic microfracture of the chondral lesion and PRP and AD-SVF injection. Receives: Procedure: Bone Marrow Stimulation; Combination Product: stromal vascular fraction (SVF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in knee clinical function questionnaire (KOOS)
Knee Injury Osteoarthritis Outcome Score is a self-administered questionnaire and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included. The resulting scores are then transformed to a scale from 0 to 100, with 0 representing extreme knee problems and 100 representing no knee problems. The scores on this scale represent the percentage of the total possible score that the person achieved.
Measured: From preoperatively (baseline) until the end of the study, up to 60 months.
Secondary outcomes (3)
Knee pain assessment
Pain intensity was measured using the Visual Analogue Scale (VAS).
Measured: From preoperatively (baseline) until the end of the study, up to 60 months.
Adverse events after the procedure
Adverse events such as knee swelling and pain with longer recovery time
Measured: Until the end of the study, up to 60 months.
Other Patient-Reported Outcome Measures
Overall physical and mental health-related quality of life was assessed with the 12-item Short Form Survey (SF-12). The SF-12 was constructed using questions drawn from each of the 8 dimensions of the MOS 36 item Short Form Survey (SF-36). It is designed to have similar performance to the SF-36, while taking less time to complete.Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12).
Additionally, the IKDC questionnaire was used to measure knee symptoms, functional limitations, and sports activity. An ordinal scoring system is used to assign a score of 0 to responses that signify the lowest level of function or the highest level of symptoms for each item. The IKDC Subjective Knee Evaluation Form is graded by adding the results of each item's scores, and then converting the result to a 0-100 scale. Higher scores indicate higher levels of function and lower levels of symptoms.
Measured: From preoperatively (baseline) to the end of the study, up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start1 May 2019
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Knee Chondral LesionStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Aquila
- Sponsor type
- University, hospital or other
- Collaborators
- Arthrex GmbH
- Responsible party
- Principal investigator, Andrea Vespasiani, Università degli Studi dell'Aquila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07255547
- Sponsor's protocol ID
- 23/2019
- Other IDs
- EMEA-18060
- Status last verified
- Aug 2025
- First submitted
- 27 Aug 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: only IPD used in the results publication
Publications
Bora P, Majumdar AS. Adipose tissue-derived stromal vascular fraction in regenerative medicine: a brief review on biology and translation. Stem Cell Res Ther. 2017 Jun 15;8(1):145. doi: 10.1186/s13287-017-0598-y.
PubMed 28619097Prodromidis AD, Charalambous CP, Moran E, Venkatesh R, Pandit H. The role of Platelet-Rich Plasma (PRP) intraarticular injections in restoring articular cartilage of osteoarthritic knees. A systematic review and meta-analysis. Osteoarthr Cartil Open. 2022 Nov 5;4(4):100318. doi: 10.1016/j.ocarto.2022.100318. eCollection 2022 Dec.
PubMed 36474791Srinivasan V, Ethiraj P, Agarawal S, H S A, Parmanantham M. Comparison of Various Modalities in the Treatment of Early Knee Osteoarthritis: An Unsolved Controversy. Cureus. 2023 Jan 11;15(1):e33630. doi: 10.7759/cureus.33630. eCollection 2023 Jan.
PubMed 36788843Cong B, Sun T, Zhao Y, Chen M. Current and Novel Therapeutics for Articular Cartilage Repair and Regeneration. Ther Clin Risk Manag. 2023 Jun 20;19:485-502. doi: 10.2147/TCRM.S410277. eCollection 2023.
PubMed 37360195Welton KL, Logterman S, Bartley JH, Vidal AF, McCarty EC. Knee Cartilage Repair and Restoration: Common Problems and Solutions. Clin Sports Med. 2018 Apr;37(2):307-330. doi: 10.1016/j.csm.2017.12.008.
PubMed 29525030Mirza MZ, Swenson RD, Lynch SA. Knee cartilage defect: marrow stimulating techniques. Curr Rev Musculoskelet Med. 2015 Dec;8(4):451-6. doi: 10.1007/s12178-015-9303-x.
PubMed 26411978
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthrosocpic Treatment of Knee Chondral Lesions: Clinical, MRI and Histologic Comparison Between the Use of PRP vs ADSCs in Addition to Marrow Stimulation Techniques
- ClinicalTrials.gov ID
- NCT07255547
- Acronym / sponsor ID
- 23/2019
- Conditions
- Knee Chondral Lesion
- Keywords
- PRP, AD-SVF, knee arthroscopy, cartilage, adipose tissue, microfracture, stromal vascular fraction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Università degli Studi dell'AquilaUniversity, hospital or other
- Collaborators
- Arthrex GmbH
- Study start
- 1 May 2019 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 1 Dec 2025 (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.
The goal of this clinical trial is to learn if PRP and adipose-derived stem cells (AD-SVF) enhance healing after knee microfracture for chondral lesions. It will also learn about the safety of the procedure. The main questions it aims to answer are:
Do PRP and AD-SVF get better results than PRP alone in patients undergoing arthroscopic microfracture for knee monocompartmental cartilage injuries? What medical problems do participants have when taking drug ABC? Researchers will compare PRP + AD-SVF to PRP alone to see if PRP + AD-SVF work better to treat knee cartilage injuries.
Participants will:
Undergo knee microfracture and biologics injections at the end of the arthroscopic procedure (PRP+AD-SVF vs PRP).
Visit the clinic for checkups and tests at baseline and at 3, 6, 12 months post-treatment, and then annually.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP | Active comparator | Procedure: Bone Marrow Stimulation, Drug: PRP injectionIn this arm, patients undergo arthroscopic microfracture of the chondral lesion and PRP injection. |
| PRP + AD-SVF | Experimental | Procedure: Bone Marrow Stimulation, Combination Product: stromal vascular fraction (SVF)In this arm, patients undergo arthroscopic microfracture of the chondral lesion and PRP and AD-SVF injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- knee pain and functional limitation for at least three months, monocompartmental chondral lesion < 2 cm2, age over 18, and BMI between 18.5 and 30
Key exclusion criteria (1 listed)
- previous major surgery on the same knee, concomitant chondral lesions in other knee compartments, being diagnosed with knee or hip osteoarthritis, knee instability, flexion deficit > 20° or extension deficit >15°, genu valgum or genu varum > 20°, patients with Hb values < 11 g/dL or platelet < 150000/µL, patients in therapy with antiaggregants or anticoagulants or immunosuppressive agents, pregnancy, and the following comorbidities: hematological/neurologic/metabolic/rheumatic diseases, neoplastic disorders or history of local infections.
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 |
|---|---|---|
| Bone Marrow StimulationAlso: knee arthroscopy, Steadman microfractureAll patients underwent an arthroscopic procedure (that further confirmed the preoperative diagnosis; i.e. monocompartmental chondral lesion - Outerbridge grade IV) including a concomitant bone marrow stimulation technique (microfracture). According to the technique described by Steadman, the cartilaginous lesion underwent preliminary debridement to remove the damaged cartilage and form a stable edge of healthy tissue and subsequent microfracture with an arthroscopic pick to stimulate the subchondral unit regenerative response. | Procedure or surgery | PRP, PRP + AD-SVF |
| stromal vascular fraction (SVF)Also: PRP injectionAfter bone marrow stimulation technique, patients were randomly assigned to one of the two treatment arms (allocation ratio 1:1). 40 patients underwent PRP injection while the other 40 underwent PRP + AD-SVF injections. | Combination product | PRP + AD-SVF |
| PRP injectionAfter bone marrow stimulation technique, patients were randomly assigned to one of the two treatment arms (allocation ratio 1:1). 40 patients underwent PRP injection while the other 40 underwent PRP + AD-SVF injections. | Drug | PRP |
Primary outcome
Change from baseline in knee clinical function questionnaire (KOOS)
Time frame: From preoperatively (baseline) until the end of the study, up to 60 months.
Knee Injury Osteoarthritis Outcome Score is a self-administered questionnaire and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included. The resulting scores are then transformed to a scale from 0 to 100, with 0 representing extreme knee problems and 100 representing no knee problems. The scores on this scale represent the percentage of the total possible score that the person achieved.
3 secondary outcomes
Knee pain assessment
Time frame: From preoperatively (baseline) until the end of the study, up to 60 months.
Adverse events after the procedure
Time frame: Until the end of the study, up to 60 months.
Other Patient-Reported Outcome Measures
Time frame: From preoperatively (baseline) to the end of the study, up to 60 months.
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 1 Dec 2025.
- Background: PubMed 28619097Bora P, Majumdar AS. Adipose tissue-derived stromal vascular fraction in regenerative medicine: a brief review on biology and translation. Stem Cell Res Ther. 2017 Jun 15;8(1):145. doi: 10.1186/s13287-017-0598-y.
- Background: PubMed 36474791Prodromidis AD, Charalambous CP, Moran E, Venkatesh R, Pandit H. The role of Platelet-Rich Plasma (PRP) intraarticular injections in restoring articular cartilage of osteoarthritic knees. A systematic review and meta-analysis. Osteoarthr Cartil Open. 2022 Nov 5;4(4):100318. doi: 10.1016/j.ocarto.2022.100318. eCollection 2022 Dec.
- Background: PubMed 36788843Srinivasan V, Ethiraj P, Agarawal S, H S A, Parmanantham M. Comparison of Various Modalities in the Treatment of Early Knee Osteoarthritis: An Unsolved Controversy. Cureus. 2023 Jan 11;15(1):e33630. doi: 10.7759/cureus.33630. eCollection 2023 Jan.
- Background: PubMed 37360195Cong B, Sun T, Zhao Y, Chen M. Current and Novel Therapeutics for Articular Cartilage Repair and Regeneration. Ther Clin Risk Manag. 2023 Jun 20;19:485-502. doi: 10.2147/TCRM.S410277. eCollection 2023.
- Background: PubMed 29525030Welton KL, Logterman S, Bartley JH, Vidal AF, McCarty EC. Knee Cartilage Repair and Restoration: Common Problems and Solutions. Clin Sports Med. 2018 Apr;37(2):307-330. doi: 10.1016/j.csm.2017.12.008.
- Background: PubMed 26411978Mirza MZ, Swenson RD, Lynch SA. Knee cartilage defect: marrow stimulating techniques. Curr Rev Musculoskelet Med. 2015 Dec;8(4):451-6. doi: 10.1007/s12178-015-9303-x.
- Individual participant dataSharing planned: Yes. only IPD used in the results publication
Related trials for Knee Chondral Lesion
Not yet recruiting
Needle Arthroscopy vs Conventional Arthroscopy in Knees
Meniscectomy, Meniscal Tears
Recruiting
Impact of Bone-Marrow Aspirate Injections in Knee Arthroscopy
Chondral Lesion of the Knee, Meniscal Injuries
Active, not recruitingObservational study
Mid- and Long-term Evaluation of the Results of Patients Undergoing Spinal Cord Stimulation With Microfractures + BST CarGel in the Treatment of Patellofemoral Chondral Lesions of the Knee
Chondral Lesion of the Knee, Patellofemoral Disorder
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 Bone Marrow Stimulation, stromal vascular fraction (SVF) and PRP injection in people with Knee Chondral Lesion, run by Università degli Studi dell'Aquila at 1 site in Italy.
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 1 inclusion and 1 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 1 Dec 2025. 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 Italy. 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?
Change from baseline in knee clinical function questionnaire (KOOS) (time frame: From preoperatively (baseline) until the end of the study, up to 60 months.). 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 NCT07255547, which also lists 6 linked publications.
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 1 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.