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Knee OsteoarthritisPhase 3NCT06570291

Allogenic Adipose-Derived Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis

A Phase 3 study testing Mesenchymal Stem Cells and Sodium Hyaluronate Injection in people with Knee Osteoarthritis, run by Wuxi Cellular Biopharmaceutical Group Ltd. at 2 sites in China.

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

Evaluate the efficacy and safety of Allogenic Adipose Tissue-Derived Mesenchymal Stem Cells Therapy Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Mesenchymal Stem Cells and Sodium Hyaluronate Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
520 participants
Where
2 sitesChina
Study dates
28 Feb 2025to Dec 2028
Phase
Phase 3
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects who understand and voluntarily sign the consent form before this study；
  • According to the diagnostic criteria (American Rheumatology Association, clinical + radiology criteria), patients with knee osteoarthritis are definitely diagnosed；Course of knee osteoarthritis was more than 6 months;
  • Age: 40-75, males and females；
  • The subjects' WOMAC score was 24-72
  • The Kellgren Lawrence grade (X-ray axial position of knee joint) of subjects was grade II / III;
  • Subjects are generally in good condition and can walk autonomously, except for those who use wheelchairs, walking aids or crutches.

Who cannot join

  • The subject may be allergic to the main cell preparation components (B vitamins, amino acids and so on).
  • The subject received systemic and / or local treatment with autologous and / or allogeneic mesenchymal progenitor cells.
  • The subject considered obese.
  • Laboratory test (any item meets): neutrophil absolute number < 1.0 × 10^9 / L, platelet count < 50 × 10^9 / L, serum albumin < 30g / L, serum creatinine > upper limit of 1.2 times normal value range, total bilirubin、alanine aminotransferase、aspartate aminotransferase > upper limit of 2 times of normal value range.
  • The subject has diseases or symptoms may affect VAS, WOMAC and so on.
  • The subject has serious and poorly controlled concomitant diseases, such as (but not limited to) nervous system, cardiovascular, liver, kidney, gastrointestinal and endocrine diseases, which may prevent the subjects from participating in the study according to the judgment of the researchers.
Show all 25Show fewer
  • The subject has an history malignant tumour.
  • The subject has connective tissue disease or rheumatoid arthritis、chondropathy、Chondrocalcinosis articularis、 Hemochromatosis、inflammatory arthropathy、avascular necrosis of femoral head、Paget's disease、hemophilic arthropathy、infectional arthritis、Charcot' s disease、villonodular synovitis or synovial chondromatosis.
  • The subject has severe generalized infectious diseases or local knee infection (including skin and intra-articular infection) in the 3 months prior to this trial.
  • According to the researchers, the subject has disease of lower limbs which may be interfered knee evaluation, for example fibromyalgia, osphyalgia, lumbar disc protrusion and so on.
  • The subject had any other coagulation dysfunction caused by acute or chronic diseases, according to the judgment of the researchers, this coagulation dysfunction may endanger the safety of patients and / or affect the judgment of knee joint evaluation indicators.
  • The subject has received arthroscopic surgery or other open surgery related to knee joint operation in the 6 months prior to this trial.
  • The subject has received other intra-articular injections, including but not limited to hyaluronic acid, hormone, PRP, BMP (bone morphogenetic protein) , hypertonic glucose and so on for KOA in the 3 months preceding the trial.
  • The subject has received aminoglucose or chondroitin sulfate within 1 month before the treatment.
  • The subject has used dexamethasone, prednisone, hydrocortisone and other hormones orally / intravenously within 1 month before the treatment.
  • The subject has attenuated or live attenuated vaccine injection with 1 month before the treatment.
  • The subject has undergone knee prosthesis or a plan of knee prosthesis within the trial.
  • The subject has contraindication of MRI, included but not only: the subject installed heart pacemaker, defibrillator, heart bracket, heart valve prosthesis, metal clip after aneurysm surgery, drug infusion device implanted in vivo, any electronic device implanted in the body (nerve stimulator, bone growth stimulator) endovascular coil, strainer, ECG monitor, metal suture, shrapnel or sand of body, plate fixation and steel nail after fracture surgery, artificial cochlea, middle ear shift plant, metallic intraocular foreign body etc; the subject is a claustrophobia, critical ill patient and so on.
  • The subject tests positive for: HIV, HBV, HCV and treponema pallidum.
  • The subject has history of alcoholism, drug abuse, or mental illness in the 3 years prior to this trial.
  • The subject has participated in any other clinical trial in the 3 months prior to this trial.
  • The subject (including male subjects) has fertility, sperm donation or egg donation plans during the trial period; the female subject is pregnant, lactating or having a positive pregnancy test.
  • The subject is legally disabled by reference to the law of the people's Republic of China on the protection of disabled persons (April 2008).
  • The subject has any other unsuitable condition (such as factors reducing the follow-up compliance) to be determined by the investigator.
  • The Kellgren Lawrence grade (X-ray axial position of knee joint) of any knee joint of the subjects was grade IV.

Trial locations and contacts

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

China2 sites, 2 recruiting

  • RenJi Hospital

    Shanghai, China

    Chunde Bao, 86-021-58752345, baochunde_1678@126.com

    Recruiting

  • Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai

    Jinwu Wang

    Not yet recruiting

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Controlled Phase III Trial of Allogenic Adipose Tissue-Derived Mesenchymal Stem Cells (AlloJoin®) Therapy for Knee Osteoarthritis.

Evaluate the efficacy and safety of Allogenic Adipose Tissue-Derived Mesenchymal Stem Cells Therapy

Being tested
Mesenchymal Stem Cells, Sodium Hyaluronate Injection
Medical subject headings
Osteoarthritis, Knee

What participants receive

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

  • Mesenchymal Stem CellsDrug

    Allogenic adipose tissue-derived mesenchymal stem cells administrated for intra- articular use

  • Sodium Hyaluronate InjectionDrug

    Sodium Hyaluronate administrated for intra-articular use

Study groups in NCT06570291
Study groupRoleWhat they receive
Mesenchymal stem cellsExperimentalNot described
Receives: Drug: Mesenchymal Stem Cells
Sodium hyaluronatePlacebo comparatorNot described
Receives: Drug: Sodium Hyaluronate Injection

What is being measured

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

  1. WOMAC score

    The Western Ontario and McMaster Universities Osteoarthritis Index;0-96 points；96 points mean a worse outcome,will be tested at 48 weeks after the first injection

    Measured: 48 weeks

  2. MRI quantitative analysis of articular cartilage

    Measured: 24 weeks

Secondary outcomes (9)

  1. WOMAC Score

    The Western Ontario and McMaster Universities Osteoarthritis Index;0-96 points；96 points mean a worse outcome, will be tested at 4、12、24、36、60、72、84 and 104 weeks after the first injection

    Measured: 4、12、24、36、60、72、84 and 104 weeks

  2. MRI quantitative analysis of articular cartilage （volume change percentage）

    Magnetic Resonance Imaging analysis of articular cartilage, will be tested at 12、48、104 weeks after the first injection

    Measured: 12、48、104 weeks

  3. MRI quantitative analysis of articular cartilage (volume change)

    Magnetic Resonance Imaging analysis of articular cartilage, will be tested at 12、24、 48 and 104 weeks after the first injection

    Measured: 12、24、 48 and 104 weeks

  4. VAS Score

    Visual Analogue Scale/Score；0-10 points；10 points mean the worse outcome,will be tested at 4、12、24、36、48、60、72、84 and 104 weeks after the first injection

    Measured: 4、12、24、36、48、60、72、84、104 weeks

  5. SF-36

    The Medical Outcomes Study 36-Item Short-Form Health Survey;0-100 points；100 points mean a better outcome, will be tested at 4、12、24、36、48、60、72、84 and 104 weeks after the first injection

    Measured: 4、12、24、36、48、60、72、84、104 weeks

  6. Whole-Organ Magnetic Resonance Imaging Score

    Whole-Organ Magnetic Resonance Imaging Score(WORMS) of the knee; 0-332points; 332 points means the worst outcome; will be assessed at 12、24、48 and104 weeks

    Measured: 12、24、48 and 104 weeks

  7. mJSW

    Minimum joint space width (mJSW) of the knee, will be measured at baseline and 104 weeks

    Measured: 104 weeks

  8. Physical examination

    Height and weight will be tested and combined to report BMI in kg/m^2at Day 0 and week 1、2、3、4、12、24、36、48、60、72、84、104 weeks

    Measured: Day 0、week 1、2、3、4、12、24、36、48、60、72、84、104 weeks

  9. Adverse Events and Serious Adverse Events

    AE and SAE, will be assessed within the 104 week time span

    Measured: Day 0 to 104 weeks

Timeline

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

  1. First posted26 Aug 2024
  2. Study start28 Feb 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
520 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06570291
Sponsor's protocol ID
CBM-MSC-007
Status last verified
Jul 2025
First submitted
22 Aug 2024
Last updated
16 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mesenchymal Stem Cells and Sodium Hyaluronate Injection in people with Knee Osteoarthritis, run by Wuxi Cellular Biopharmaceutical Group Ltd. at 2 sites in China.

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 25 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 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. 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. Some participants in this study may receive a placebo. 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?

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

WOMAC score (time frame: 48 weeks). 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 NCT06570291.

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 16 Jul 2025.

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