AzTrials
AzTrials

OsteoarthritisNCT07901790

Autologous Adipose-Derived Stem Cell Injections for Knee Osteoarthritis

A study testing Autologous Adipose-Derived Mesenchymal Stem Cells (ADMSCs) and Cross-linked Hyaluronic Acid (Synovian) in people with Osteoarthritis and Knee, run by Yonsei University at 3 sites in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This multicenter, prospective, randomized, active-controlled, single-blind (assessor-blinded) clinical trial aims to evaluate the efficacy and safety of intra-articular injection of autologous adipose-derived mesenchymal stem cells (ADMSCs) compared with active comparator hyaluronic acid (HA) in patients with… Read more about this study

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Osteoarthritis, Knee, Knee Osteoarthritis
What is being tested?
Autologous Adipose-Derived Mesenchymal Stem Cells (ADMSCs) and Cross-linked Hyaluronic Acid (Synovian)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
165 participants
Where
3 sitesSouth Korea
Study dates
3 Sep 2026to 31 May 2028
Phase
Interventional
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 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged 40 to 70 years at the time of written informed consent.
  • Knee osteoarthritis diagnosed according to American College of Rheumatology (ACR) criteria with persistent knee pain for at least 3 months.
  • Radiographic Kellgren-Lawrence (KL) grade II or grade III in the target knee.
  • Activity pain score of >= 40 mm on a 100-mm Visual Analog Scale (VAS) in the target knee.
  • Unilateral or bilateral knee OA. In bilateral cases, one target knee must be designated according to criteria 1-4 (if both knees meet criteria, the more painful/symptomatic knee is selected).
  • Voluntary provision of written informed consent.

Who cannot join

  • Secondary knee osteoarthritis caused by infection, rheumatoid arthritis, or inflammatory joint disease.
  • Pain caused by meniscus posterior horn root tear within 3 months prior to screening.
  • Pain judged to be caused by subchondral insufficiency fracture or osteonecrosis.
  • Conditions affecting joint pain or prognosis (e.g., gout, pseudogout, periarticular fracture, hemochromatosis, Wilson's disease, hypermobility, collagen gene disorders).
  • Body Mass Index (BMI) >= 35 kg/m2.
  • Prior total knee arthroplasty (TKA) or unicompartmental knee arthroplasty (UKA) in the target knee (prior HTO or partial meniscectomy >= 6 months with stable status is permitted).
Show all 16Show fewer
  • Recent target knee treatments: cross-linked HA, cell therapy, or gene therapy within 6 months; linear HA or intra-articular corticosteroid within 3 months; oral NSAIDs, glucosamine, chondroitin, or oral steroids within 14 days prior to injection.
  • Uncontrolled type 1 or type 2 diabetes (HbA1c > 8.5% at screening).
  • Positive test for Human Immunodeficiency Virus (HIV) antibody.
  • History of malignant neoplasm within 3 years prior to screening.
  • Participation in another clinical trial within 60 days prior to screening.
  • Clinically significant abnormal screening laboratory findings.
  • Psychiatric disorder, alcohol/drug abuse affecting adherence or safety.
  • Pregnant or breastfeeding women.
  • Women of childbearing potential or men unwilling to use medically acceptable contraception during the trial.
  • Judged ineligible by the investigator.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sung-Hwan Kim, M.D., Ph.D. contact

+82-2-2228-5679

orthohwan@gmail.com

South Korea3 sites, 3 recruiting
  • Inha University Hospital

    Incheon

    Dong-Jin Ryu, Professor, +82-10-4112-7127, jhdms7827@gmail.com

    Recruiting
  • Seoul National University Hospital

    Seoul

    Byung-Sun Choi, Professor, +82-10-8763-1007, harufox@snu.ac.kr

    Recruiting
  • Severance Hospital

    Seoul

    Sung-Hwan Kim, M.D., Ph.D., +82-2-2228-5679, orthohwan@gmail.com

    Recruiting

Other trials in South Korea

About this study

Official title: Efficacy and Safety of Intra-articular Autologous Adipose-Derived Mesenchymal Stem Cell Injections for Improving Clinical Function in Patients With Knee Osteoarthritis: A Multicenter, Prospective, Randomized, Active-Controlled Trial

This multicenter, prospective, randomized, active-controlled, single-blind (assessor-blinded) clinical trial aims to evaluate the efficacy and safety of intra-articular injection of autologous adipose-derived mesenchymal stem cells (ADMSCs) compared with active comparator hyaluronic acid (HA) in patients with Kellgren-Lawrence grade II to III knee osteoarthritis. A total of 165 participants across 3 centers (Severance Hospital, Seoul National University Hospital, Inha University Hospital) will be randomly allocated to either the ADMSC group (1.0 x 10^8 cells, single injection) or the HA group (Synovian, 3 mL) in a 2:1 ratio and followed for 6 months post-injection.

Read the detailed description

Osteoarthritis (OA) is a prevalent degenerative joint disease characterized by progressive loss of articular cartilage, chronic pain, and joint dysfunction. Autologous adipose-derived mesenchymal stem cells (ADMSCs) offer potential cartilage protective and anti-inflammatory properties. In this confirmatory trial, 165 eligible adults aged 40 to 70 years with radiographic KL grade II or III knee OA and persistent pain (VAS >= 40 mm) will undergo abdominal fat harvest. Participants will be randomized 2:1 to receive either an ultrasound-guided intra-articular injection of autologous ADMSCs (1.0 x 10^8 cells suspended in 3 mL CryoStor 10) or high molecular weight cross-linked hyaluronic acid (Synovian 3 mL). Follow-up visits occur at 1, 3, and 6 months post-injection. The primary endpoint is the change from baseline in the WOMAC total score at 6 months. Secondary endpoints include changes in WOMAC subscales, VAS pain, KOOS subscores, responder rates (OMERACT-OARSI and MCID), structural outcomes on MRI (MOCART 2.0, MOAKS) and X-ray, rescue medication usage, exploratory synovial/serum biomarkers (COMP, CTX-II), and comprehensive safety profiles through 6 months. After completing the 6-month evaluation, participants allocated to the control group are offered autologous ADMSC injection.

Being tested
Autologous Adipose-Derived Mesenchymal Stem Cells (ADMSCs), Cross-linked Hyaluronic Acid (Synovian)
Keywords
Knee Osteoarthritis, Mesenchymal Stem Cells, Adipose-Derived Stem Cells, Intra-articular Injection, Hyaluronic Acid, WOMAC, Cartilage Regeneration
Medical subject headings
Osteoarthritis, Osteoarthritis, Knee

What participants receive

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

  • Autologous Adipose-Derived Mesenchymal Stem Cells (ADMSCs)Biological

    Also called ADMSCs, Autologous Adipose-derived Stem Cells, ADSC Intra-articular Injection

    Single intra-articular injection of 1.0 x 10^8 culture-expanded autologous ADMSCs suspended in 3 mL cryopreservation medium (CryoStor 10) under ultrasound guidance.

  • Cross-linked Hyaluronic Acid (Synovian)Drug

    Also called Synovian, High molecular weight crosslinked HA, Hyaluronic Acid

    Single intra-articular injection of 3 mL high molecular weight cross-linked hyaluronic acid (Synovian Inj., LG Chem) administered under ultrasound guidance.

Study groups in NCT07901790
Study groupRoleWhat they receive
Autologous ADMSC InjectionExperimentalArm Description: Participants receive a single ultrasound-guided intra-articular injection of autologous adipose-derived mesenchymal stem cells (1.0 x 10^8 cells/3 mL CryoStor 10) isolated and culture-expanded from the participant's abdominal subcutaneous adipose tissue.
Receives: Biological: Autologous Adipose-Derived Mesenchymal Stem Cells (ADMSCs)
Hyaluronic Acid InjectionActive comparatorParticipants undergo identical abdominal liposuction and receive a single ultrasound-guided intra-articular injection of high-molecular-weight cross-linked hyaluronic acid (Synovian 3 mL). At the completion of the 6-month study period, cross-over autologous ADMSC injection is provided.
Receives: Drug: Cross-linked Hyaluronic Acid (Synovian)

What is being measured

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

  1. Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 6 Months

    The WOMAC total score assesses pain, stiffness, and physical function on a standardized scale. Higher scores indicate worse pain and functional limitation. The primary efficacy endpoint is the between-group difference in the change from baseline to 6 months post-injection, analyzed using analysis of covariance (ANCOVA).

    Measured: Baseline and 6 months post-injection

Secondary outcomes (8)
  1. Change from Baseline in WOMAC Subscale Scores

    Changes in individual WOMAC subscales: pain (5 items), stiffness (2 items), and physical function (17 items).

    Measured: Baseline, 1, 3, and 6 months post-injection

  2. Change from Baseline in Visual Analog Scale (VAS) Pain Score

    Knee pain assessed on a 100-mm Visual Analog Scale (VAS, 0 = no pain, 100 = worst pain).

    Measured: Baseline, 1, 3, and 6 months post-injection

  3. Change from Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscores

    Changes in KOOS subscales (Pain, Symptoms, ADL, Sport/Rec, and QOL; each scored 0-100, where 100 represents no symptoms/best function).

    Measured: Baseline, 1, 3, and 6 months post-injection

  4. Proportion of Clinical Responders (MCID and OMERACT-OARSI criteria)

    Responder rates evaluated by minimal clinically important difference (MCID: WOMAC >= 9-point reduction, VAS >= 14-mm reduction) and OMERACT-OARSI criteria.

    Measured: 6 months post-injection

  5. Magnetic Resonance Imaging (MRI) Assessment of Cartilage

    Evaluation of articular cartilage morphologic repair and progression using MOCART 2.0 (Magnetic Resonance Observation of Cartilage Repair Tissue) and MOAKS (MRI Osteoarthritis Knee Score).

    Measured: Baseline and 6 months post-injection

  6. Radiographic Progression on Plain Radiographs (X-ray)

    Changes in Kellgren-Lawrence (KL) grade and Hip-Knee-Ankle (HKA) mechanical alignment angle.

    Measured: Baseline, 3 months, and 6 months post-injection

  7. Rescue Medication Usage

    Proportion of participants requiring rescue medication (acetaminophen), cumulative tablet count, and days of rescue medication intake.

    Measured: Throughout the 6-month study period

  8. Incidence and Severity of Adverse Events

    Incidence, severity, and causality of all adverse events (AEs), serious adverse events (SAEs), and local injection-site reactions according to NCI-CTCAE v6.0 and WHO-UMC criteria.

    Measured: Throughout the 6-month study period

Timeline

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

  1. First posted28 Oct 2026
  2. Study start3 Sep 2026
  3. Primary completion29 Feb 2028 (estimated)
  4. Study completion31 May 2028 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel assignment with 2:1 randomization ratio to autologous ADMSC injection (1.0 x 10\^8 cells) or active control hyaluronic acid (Synovian) injection.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
165 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07901790
Sponsor's protocol ID
4-2026-0933
Status last verified
Oct 2026
First submitted
22 Oct 2026
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The plan to share individual participant data with other researchers has not yet been determined.

Publications

  • Skidmore S, Hill MA, Bishara K, Konsek H, Kwon JH, Brockbank KGM, Rajab TK. Morbidity and Mortality of Heterotopic Partial Heart Transplantation in Rodent Models. J Cardiovasc Dev Dis. 2023 May 26;10(6):234. doi: 10.3390/jcdd10060234.

    PubMed 37367399
  • Servia L, Jove M, Sol J, Pamplona R, Badia M, Montserrat N, Portero-Otin M, Trujillano J. A prospective pilot study using metabolomics discloses specific fatty acid, catecholamine and tryptophan metabolic pathways as possible predictors for a negative outcome after severe trauma. Scand J Trauma Resusc Emerg Med. 2019 May 22;27(1):56. doi: 10.1186/s13049-019-0631-5.

    PubMed 31118076
  • Walshe EA, Romer D, Wyner AJ, Cheng S, Elliott MR, Zhang R, Gonzalez AK, Oppenheimer N, Winston FK. Licensing Examination and Crash Outcomes Postlicensure in Young Drivers. JAMA Netw Open. 2022 Apr 1;5(4):e228780. doi: 10.1001/jamanetworkopen.2022.8780.

    PubMed 35467733
  • Wang MK, Chin-Yee B, Lo CK, Lee S, El-Helou P, Alowami S, Gangji A, Ribic C. Crusted scabies in a renal transplant recipient treated with daily ivermectin: A case report and literature review. Transpl Infect Dis. 2019 Jun;21(3):e13077. doi: 10.1111/tid.13077. Epub 2019 Mar 29.

    PubMed 30873722
  • Jo CH, Lee YG, Shin WH, Kim H, Chai JW, Jeong EC, Kim JE, Shim H, Shin JS, Shin IS, Ra JC, Oh S, Yoon KS. Intra-articular injection of mesenchymal stem cells for the treatment of osteoarthritis of the knee: a proof-of-concept clinical trial. Stem Cells. 2014 May;32(5):1254-66. doi: 10.1002/stem.1634.

    PubMed 24449146

Questions about this trial

What is this clinical trial studying?

A study testing Autologous Adipose-Derived Mesenchymal Stem Cells (ADMSCs) and Cross-linked Hyaluronic Acid (Synovian) in people with Osteoarthritis and Knee, run by Yonsei University at 3 sites in South Korea.

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 6 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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.

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?

Contact Sung-Hwan Kim, M.D., Ph.D. (+82-2-2228-5679, orthohwan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 6 Months (time frame: Baseline and 6 months post-injection). 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 NCT07901790, which also lists 5 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 28 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in