Articular Cartilage DefectPhase 3NCT05051332

Phase 3 Clinical Trial of CartiLife® in Korea

A Phase 3 study testing Autologous Chondrocyte Implantation (CartiLife®) and Microfracture Surgery in people with Articular Cartilage Defect and Articular Cartilage Degeneration, run by Biosolution Co., Ltd. at 18 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

To evaluate the safety and efficacy of pellet-type extracellular matrix-associated autologous chondrocytes (CartiLife®) obtained by cultivating costal chondrocytes of the subject implanted into articular cartilage defects of the knee resulting from trauma or degeneration. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Articular Cartilage Defect, Articular Cartilage Degeneration
What is being tested?: Autologous Chondrocyte Implantation (CartiLife®) and Microfracture Surgery
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 104 participants
Where: 18 sitesSouth Korea
Study dates: 19 Mar 2020to 30 Sep 2024
Phase: Phase 3
Are there results?: None posted in the registry

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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

In order to be eligible to participate in this study, an individual must meet all of the following:
Patients over the age of 18.
Defect size: 2 to 10 cm^2 on the unilateral knee cartilage (up to 4 ㎤ in volume).
Defect: isolated ICRS (International Cartilage Repair Society) grade III or IV single defect chondral lesion on articular cartilage with comparatively healthy cartilage present near the lesion site (ICRS Grade 1 ~ 2).
Patients with a KOOS total score below 55.
Patients able to walk without aid.
Patients who agree to abide by rehabilitation protocols and follow-up programs, including residential exercise routines.
Patients who provide written consent to the application of the clinical trial.

Who cannot join

Individuals who meet any of the following will be excluded from participation in this study:
Patients with inflammatory articular diseases such as rheumatoid arthritis or gouty arthritis.
Patients scoring 3 or above on the Kellgren-Lawrence Grading Scale.
Patients with inflammatory articular diseases related to autoimmune diseases.
Patients hypersensitive to bovine derived proteins or any of the components in this product.
Patients hypersensitive to Gentamycin.

Show all 13Show fewer

Patients with Haemophilia or markedly reduced immune function.
Patients with arterial bleeding and severe venous bleeding.
Patients with other diseases including tumors except for cartilaginous defects of joints.
Patients with a history of radiation treatment and chemotherapy within the past two years.
Patients who are pregnant, or nursing a baby.
Patients who participate in concurrent clinical trials or previous clinical trials within 30 days of administration.
Other cases where the investigator deems the patient ineligible for participation.

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

South Korea18 sites

Inje University Haeundae Paik Hospital
Busan, 48108
Kosin University Gospel Hospital
Busan, 49267
Chungnam National University Hospital
Daejeon, 35015
Chonnam National University Hwasun Hospital
Gwangju, 58128
Chosun University Hospital
Gwangju, 61453
Pusan National University Hospital
Pusan, 35015
Seoul National University Bundang Hospital (1)
Seongnam-si, 13620
Seoul National University Bundang Hospital (2)
Seongnam-si, 13620
Kyung Hee University Hospital
Seoul, 02447
Seoul National University Hospital
Seoul, 03080
Severance Hospital
Seoul, 03722
Kyung Hee University Hospital at Gangdong
Seoul, 05278
Gangnam Severance Hospital
Seoul, 06230
Samsung Medical Center
Seoul, 06351
Ewha Womans University Mokdong Hospital
Seoul, 07985
Korea University Guro Hospital
Seoul, 08308
The Catholic UNIV. of Korea Seoul St. Mary's Hospital
Seoul, 16591
The Catholic UNIV. of Korea Uijeongbu St. Mary's Hospital
Uijeongbu-si, 11765

Other trials in South Korea

About this study

Official title: A Multi-Center, Active-Controlled, Open-Label, Phase III Trial to Compare the Efficacy and Safety for Treatment of Autologous Chondrocytes Implantation With CartiLife Versus Microfracture for Patients With Knee Chondral Defects

Read the detailed description

This open-label, phase 3 study is being conducted to evaluate the safety and efficacy of pellet-type extracellular matrix-associated autologous chondrocytes (CartiLife®) compared with microfracture surgery in adults with articular cartilage defects due to trauma or degeneration of the knee. It is hypothesized that CartiLife® treatment will demonstrate structural regeneration and improvement in function and pain at Week 48 compared to baseline.

Conditions: Articular Cartilage Defect, Articular Cartilage Degeneration
Being tested: Autologous Chondrocyte Implantation (CartiLife®), Microfracture Surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Autologous Chondrocyte Implantation (CartiLife®)Drug
Also called CartiLife
CartiLife consists of small beads (1 mm in diameter) in suspension, developed from pellet culture of autologous costal chondrocytes after multiplication. The beads are implanted in an injective manner with fibrin glue through minimal arthrotomy. The dose depends on the size (volume) of the defect, recommended dose is 480 pellets/cm^3 defect
Microfracture SurgeryProcedure or surgery
Microfracture surgery, performed by arthroscopy after the joint is cleaned of calcified cartilage, will be conducted using an awl or drill to create tiny fractures in the subchondral bone plate

Study groups in NCT05051332
Study group	Role	What they receive
CartiLife®	Experimental	Extracellular matrix-associated autologous chondrocytes comprise CartiLife®, composed as pellets (1.1 to 1.8 mm in diameter) in suspension. One pre-filled syringe is implanted per 1 cm^3 of defect volume, and fibrin adhesive is applied to fix pellets in place through minimal arthrotomy. Receives: Drug: Autologous Chondrocyte Implantation (CartiLife®)
Microfracture Surgery	Active comparator	Microfracture surgery, performed by arthroscopy after the joint is cleaned of calcified cartilage, will be conducted using an awl or drill to create tiny fractures in the subchondral bone plate. Receives: Procedure: Microfracture Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue)
MOCART is a validated tool that provides reliable, reproducible, and accurate assessment of cartilage repair tissue (Marlovits et al, 2006 that; Trattnig et al, 2011).
Measured: At Week 48, post-operation
KOOS Total Score
The KOOS is a reliable and valid patient-reported outcome measurement tool that evaluates both short-term and long-term consequences of knee injury. The 5 separately scored subscales of Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related QOL may enrich clinical and research data interpretation (Roos and Lohmander, 2003; Collins et al, 2011).
In the 'Knee injury and Osteoarthritis Outcome Score', scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.
Measured: From Week 0 to Week 48, post-operation

Secondary outcomes (8)

MOCART Score
MOCART is a validated tool that provides reliable, reproducible, and accurate assessment of cartilage repair tissue (Marlovits et al, 2006 that; Trattnig et al, 2011).
In the 'Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Score', the total score ranges from 0 to 100, with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.
Measured: At Week 24 and Week 96, post-operation
Lysholm Score
The Lysholm scale is a broadly applicable, validated tool for measuring changes following nonsurgical and surgical intervention, as well as deterioration over time in patients with various knee pathologies (Collins et al, 2011).
In the 'Lysholm score', the total score ranges from 0 to 100, with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.
Measured: At Week 0 to Week 8, 24, 48 and 96, post-operation
IKDC Score
The IKDC Knee form covers domains likely to be important to patients and has adequate consistency and broad applicability across mixed groups of patients (Collins et al, 2011).
In the 'International Knee Documentation Committee Subjective Knee Form', the total score ranges from 0 to 100, with a score of 0 indicating the worst knee symptoms(lowest level of function or highest level of symptoms) and 100 indicating no knee symptoms(highest level of function and lowest level of symptoms).
Measured: At Week 0 to Week 8, 24, 48 and 96, post-operation
KOOS Score (Pain, Other symptoms, Function in daily living, Function in sport and recreation, and knee-related QOL subscales)
The KOOS is a reliable and valid patient-reported outcome measurement tool that evaluates both short-term and long- term consequences of knee injury. The 5 separately scored subscales of Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related QOL may enrich clinical and research data interpretation (Roos and Lohmander, 2003; Collins et al, 2011).
KOOS Score (Pain, Other symptoms, Function in daily living, Function in sport and recreation, and knee-related QOL subscales) are measured between 0, 1, 2, 3 and 4. The KOOS subscales are scored separately: Pain (9 items); Symptoms (7 items); Function in daily living (17 items); Function in sport and recreation (5 items); knee-related QOL (4 items). Each scale is scored between 0 to 4. The total score ranges from 0 to 100, with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.
Measured: At Week 0 to Week 8, 24, 48 and 96, post-operation
VAS (100mm Pain Visual Analogue Scale)
The VAS is a validated, ubiquitous tool for patient-reported measurement of pain at a given point in time (Kersten et al, 2014).
Visual Analogue Scale (VAS) is a measurement instrument that measures a specified characteristic which is deemed difficult to quantify across a continuous line of value to determine its representative value. The VAS scale ranges from 0 to 100 mm, with 0 indicating absence of pain and 100 indicating the worst pain experienced.
Measured: At Week 0 to Week 8, 24, 48 and 96, post-operation
Tegner Activity Scale
The Tegner activity score is a frequently used patient-administered activity rating system for patients with various knee activity functions. The instrument scores a person's activity level between 0 and 10 where 0 is 'on sick leave/disability' and 10 is 'participation in competitive sports such as soccer at a national or international elite level' (Karen Hambly, 2011). A level of 0 indicates that the patient is unable to participate in activities barring 'Sick leave or disability pension because of knee problems', and a level of 10 indicates that the patient is capable of participating in activities which at its most intense include 'Competitive sports - soccer, football, rugby at a national elite level'.
Measured: At Week 0 to Week 8, 24, 48 and 96, post-operation
Pain medication history
Pain medication history is an indicator of patient pain. Pain medication history is an indicator of patient pain. The frequency of analgesic ingestion is measured for the specified duration over the course of the clinical trial, and changes in analgesic ingestion in terms of frequency are assessed to analyze the efficacy of the clinical trial product.
Measured: At Week 0 to Week 8, 24, 48 and 96, post-operation
Treatment related adverse events
Number of subjects with treatment related adverse events as assessed by analysis of adverse events including symptoms, abnormal findings on physical examination, vital signs, ECG, and standard laboratory examination results. The total number of patients who exhibit symptoms identified as an adverse event will be cumulatively combined to obtain a whole digit number representing the number of patients who have suffered an adverse event throughout the course of the clinical trial.
Measured: At Week 0 (pre-operation), and up to 24 Months (post-operation)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Mar 202030 Sep 2024

First posted21 Sep 2021
Study start19 Mar 2020
Primary completion30 Sep 2023 (estimated)
Study completion30 Sep 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Articular Cartilage DefectStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Investigational Group : CartiLife® Procedure: Extracellular matrix-associated autologous chondrocytes comprise CartiLife®, composed as pellets (1.1 to 1.8 mm in diameter) in suspension. One pre-filled syringe is implanted per 1 cm\^3 of defect volume, and fibrin adhesive is applied to fix pellets in place through minimal arthrotomy. Active comparator: Microfracture Surgery Procedure : Microfracture surgery, performed by arthroscopy after the joint is cleaned of calcified cartilage, will be conducted using an awl or drill to create tiny fractures in the subchondral bone plate.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 104 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05051332
Sponsor's protocol ID: BS-CTL-III
Status last verified: Sep 2021
First submitted: 4 Aug 2021
Last updated: 17 May 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: There are no future plans to share the IPD at this time.

Publications

Yoon KH, Park JY, Lee JY, Lee E, Lee J, Kim SG. Costal Chondrocyte-Derived Pellet-Type Autologous Chondrocyte Implantation for Treatment of Articular Cartilage Defect. Am J Sports Med. 2020 Apr;48(5):1236-1245. doi: 10.1177/0363546520905565. Epub 2020 Mar 3.
PubMed 32125878
Yoon KH, Yoo JD, Choi CH, Lee J, Lee JY, Kim SG, Park JY. Costal Chondrocyte-Derived Pellet-Type Autologous Chondrocyte Implantation versus Microfracture for Repair of Articular Cartilage Defects: A Prospective Randomized Trial. Cartilage. 2021 Dec;13(1_suppl):1092S-1104S. doi: 10.1177/1947603520921448. Epub 2020 Jun 1.
PubMed 32476445

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
BioPoly® Partial Resurfacing Knee Implant IDE
Knee Pain Chronic, Knee Osteoarthritis
RecruitingPhase 3
A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle
Chondral Defect, Articular Cartilage Defect
RecruitingPhase 3
A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee
Chondral Defect, Osteochondritis Dissecans (OCD)
Not yet recruiting
Biologic Augmentation of Osteochondral Allograft Transplantation in the Knee
Osteochondral Defect, Articular Cartilage Defect
RecruitingPhase 1
AMIC Compared With Microfracture for Focal Articular Cartilage Damage of the Hip
Hip Arthroscopy, Articular Cartilage Defect

All Articular Cartilage Defect trials

Study at a glance

From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Active-Controlled, Open-Label, Phase III Trial to Compare the Efficacy and Safety for Treatment of Autologous Chondrocytes Implantation With CartiLife Versus Microfracture for Patients With Knee Chondral Defects
ClinicalTrials.gov ID: NCT05051332
Acronym / sponsor ID: BS-CTL-III
Conditions: Articular Cartilage Defect, Articular Cartilage Degeneration
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 104 participants (estimated)
Lead sponsor: Biosolution Co., Ltd.Industry (pharma, biotech, devices)
Study start: 19 Mar 2020 (actual)
Primary completion: 30 Sep 2023 (estimated)
Study completion: 30 Sep 2024 (estimated)
First posted: 21 Sep 2021 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Investigational Group : CartiLife® Procedure: Extracellular matrix-associated autologous chondrocytes comprise CartiLife®, composed as pellets (1.1 to 1.8 mm in diameter) in suspension. One pre-filled syringe is implanted per 1 cm^3 of defect volume, and fibrin adhesive is applied to fix pellets in place through minimal arthrotomy. Active comparator: Microfracture Surgery Procedure : Microfracture surgery, performed by arthroscopy after the joint is cleaned of calcified cartilage, will be conducted using an awl or drill to create tiny fractures in the subchondral bone plate.

Arm	Type	Receives
CartiLife®	Experimental	Drug: Autologous Chondrocyte Implantation (CartiLife®)Extracellular matrix-associated autologous chondrocytes comprise CartiLife®, composed as pellets (1.1 to 1.8 mm in diameter) in suspension. One pre-filled syringe is implanted per 1 cm^3 of defect volume, and fibrin adhesive is applied to fix pellets in place through minimal arthrotomy.
Microfracture Surgery	Active comparator	Procedure: Microfracture SurgeryMicrofracture surgery, performed by arthroscopy after the joint is cleaned of calcified cartilage, will be conducted using an awl or drill to create tiny fractures in the subchondral bone plate.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

In order to be eligible to participate in this study, an individual must meet all of the following:
Patients over the age of 18.
Defect size: 2 to 10 cm^2 on the unilateral knee cartilage (up to 4 ㎤ in volume).
Defect: isolated ICRS (International Cartilage Repair Society) grade III or IV single defect chondral lesion on articular cartilage with comparatively healthy cartilage present near the lesion site (ICRS Grade 1 ~ 2).
Patients with a KOOS total score below 55.

Key exclusion criteria (13 listed)

Individuals who meet any of the following will be excluded from participation in this study:
Patients with inflammatory articular diseases such as rheumatoid arthritis or gouty arthritis.
Patients scoring 3 or above on the Kellgren-Lawrence Grading Scale.
Patients with inflammatory articular diseases related to autoimmune diseases.
Patients hypersensitive to bovine derived proteins or any of the components in this product.

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
Autologous Chondrocyte Implantation (CartiLife®)Also: CartiLifeCartiLife consists of small beads (1 mm in diameter) in suspension, developed from pellet culture of autologous costal chondrocytes after multiplication. The beads are implanted in an injective manner with fibrin glue through minimal arthrotomy. The dose depends on the size (volume) of the defect, recommended dose is 480 pellets/cm^3 defect	Drug	CartiLife®
Microfracture SurgeryMicrofracture surgery, performed by arthroscopy after the joint is cleaned of calcified cartilage, will be conducted using an awl or drill to create tiny fractures in the subchondral bone plate	Procedure or surgery	Microfracture Surgery

Primary outcome

MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue)
Time frame: At Week 48, post-operation
MOCART is a validated tool that provides reliable, reproducible, and accurate assessment of cartilage repair tissue (Marlovits et al, 2006 that; Trattnig et al, 2011).
KOOS Total Score
Time frame: From Week 0 to Week 48, post-operation
The KOOS is a reliable and valid patient-reported outcome measurement tool that evaluates both short-term and long-term consequences of knee injury. The 5 separately scored subscales of Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related QOL may enrich clinical and research data interpretation (Roos and Lohmander, 2003; Collins et al, 2011). In the 'Knee injury and Osteoarthritis Outcome Score', scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.

8 secondary outcomes

MOCART Score
Time frame: At Week 24 and Week 96, post-operation
Lysholm Score
Time frame: At Week 0 to Week 8, 24, 48 and 96, post-operation
IKDC Score
Time frame: At Week 0 to Week 8, 24, 48 and 96, post-operation
KOOS Score (Pain, Other symptoms, Function in daily living, Function in sport and recreation, and knee-related QOL subscales)
Time frame: At Week 0 to Week 8, 24, 48 and 96, post-operation
VAS (100mm Pain Visual Analogue Scale)
Time frame: At Week 0 to Week 8, 24, 48 and 96, post-operation
Tegner Activity Scale
Time frame: At Week 0 to Week 8, 24, 48 and 96, post-operation
Pain medication history
Time frame: At Week 0 to Week 8, 24, 48 and 96, post-operation
Treatment related adverse events
Time frame: At Week 0 (pre-operation), and up to 24 Months (post-operation)

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
Background: PubMed 32125878Yoon KH, Park JY, Lee JY, Lee E, Lee J, Kim SG. Costal Chondrocyte-Derived Pellet-Type Autologous Chondrocyte Implantation for Treatment of Articular Cartilage Defect. Am J Sports Med. 2020 Apr;48(5):1236-1245. doi: 10.1177/0363546520905565. Epub 2020 Mar 3.
Background: PubMed 32476445Yoon KH, Yoo JD, Choi CH, Lee J, Lee JY, Kim SG, Park JY. Costal Chondrocyte-Derived Pellet-Type Autologous Chondrocyte Implantation versus Microfracture for Repair of Articular Cartilage Defects: A Prospective Randomized Trial. Cartilage. 2021 Dec;13(1_suppl):1092S-1104S. doi: 10.1177/1947603520921448. Epub 2020 Jun 1.
Individual participant dataSharing planned: No. There are no future plans to share the IPD at this time.

Related trials for Articular Cartilage Defect

Recruiting
BioPoly® Partial Resurfacing Knee Implant IDE
Knee Pain Chronic, Knee Osteoarthritis
RecruitingPhase 3
A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle
Chondral Defect, Articular Cartilage Defect
RecruitingPhase 3
A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee
Chondral Defect, Osteochondritis Dissecans (OCD)
Not yet recruiting
Biologic Augmentation of Osteochondral Allograft Transplantation in the Knee
Osteochondral Defect, Articular Cartilage Defect
RecruitingPhase 1
AMIC Compared With Microfracture for Focal Articular Cartilage Damage of the Hip
Hip Arthroscopy, Articular Cartilage Defect

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.

Jungsun Lee, Ph.D study director

Biosolution Co., Ltd.

Kyoung Ho Yoon, MD principal investigator

Kyung Hee University Hospital

Jae Doo Yoo, MD principal investigator

Ewha Womans University Mokdong Hospital

18 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue) (time frame: At Week 48, post-operation). The study lists 2 primary outcomes in all. 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 NCT05051332, which also lists 2 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 17 May 2022.