Osteoarthritis, KneePhase 2NCT03383081
The Safety/Efficacy of hUC Mesenchymal Stem Cells（19#iSCLife®-OA） Therapy for Patients With Osteoarthritis
A Phase 2 study testing Low dose mesenchymal stem cells, High dose mesenchymal stem cells and Intraarticular injection in people with Osteoarthritis, Knee, run by Sclnow Biotechnology Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is verify the efficacy and safety of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSC) therapy for patients with Osteoarthritis, and in addition, provide basis for exploring the treatment regimen of UC-MSC therapy in different degree of cartilage defect disease Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Low dose mesenchymal stem cells, High dose mesenchymal stem cells and Intraarticular injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2018to 31 Dec 2026
- Phase
- Phase 2
- 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 Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of Knee Osteoarthritis by Kellgren and Lawrence Grading Scale, classified with Grade 2-3
- Confirm with cartilage injury,articular cartilage part or full-thickness injury, by MR (Magnetic Resonance)
- Age <70, no serious organ dysfunction
- Over 2 years knee pain or no very effective with conservative treatments
- Knee pain of VAS (visual analog scale score) is 4 or higher
- Normal hepatic and renal function, no history of gout, rheumatoid arthritis, and autoimmune diseases, etc.
- Understand and sign the consent form of this study
Who cannot join
- Refuse to sign the consent form, or cannot keep follow-up visit
- Age >70; Age <70, but with multiple organ failure
- Unstable vital signs (breath, blood pressure, pulse)
- Combined with knee ligament (anterior and the posterior cruciate ligament, medial and lateral collateral ligament) rupture, laxity, etc.
- Serious bleeding tendency, poor coagulation function (PTA <35%)
- Pregnant or breast feeding women, or positive pregnancy test in 7 days before treatment
Show all 18Show fewer
- Participate other clinical experiments in 3 months
- With progressing malignant tumor
- Combined with shock and critically ill patients
- With mental disease, cannot
- With history of knee joint infection, surgery, and radiotherapy
- With immunosuppressive agents treatment in 6 weeks
- Injection with hormones and sodium hyaluronate in joint in 3 months
- Overweight expressed as body mass index (BMI) >35
- With skin disease around knee joint
- With Immunodeficiency disease, including long term use immunosuppressive agents patients
- Combined with serious infection
- With some other conditions that doctor propose not to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xiangya Hospital Central South University
Changsha, Hunan, 410008
Hongbin Lu, 15874889777, hongbinlu@hotmail.com
About this study
Official title: A Clinical Research on the Safety/Efficacy of Human Umbilical Cord Mesenchymal Stem Cells（19#iSCLife®-OA） Therapy for Patients With Osteoarthritis
The purpose of this study is verify the efficacy and safety of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSC) therapy for patients with Osteoarthritis, and in addition, provide basis for exploring the treatment regimen of UC-MSC therapy in different degree of cartilage defect disease
Read the detailed description
This is a random, open label, and parallel controled experiment. All patients are selected and sign consent forms, then divided into 3 groups. Doctors collect the basic information of patient. All patients receive laboratory and image examination as baseline. Then, they will give cell treatment based on the clinical protocol. Doctors have follow-up visit on 2 weeks, 1, 2, 3, 6, and 12 months after treatment, and do safety and efficacy evaluation.
Safety evaluation. Researcher collect all examination data of patients and compare with each groups. The safety tests including blood routine, urine routine, hepatorenal function, C reactive protein, erythrocyte sedimentation rate, and tumor marker, etc.
Efficacy evaluation. Based on Lysholm, the international knee documentation committee (IKDC) knee evaluation form, and Visual Analogue Scale/Score (VAS) to examine the change/improvement of knee joint function. By Magnetic Resonance Imaging (MRI) examination, grade patients with Kellgren-Lawrence Grading Scale, Assessment of Preoperative Cartilage Defect Severity (AMADEUS), and observe the change/improvement of patient.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Low dose mesenchymal stem cells, High dose mesenchymal stem cells, Intraarticular injection
- Keywords
- osteoarthritis, mesenchymal stem cell
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose mesenchymal stem cellsBiological
Human umbilical cord mesenchymal stem cells (SCLnow 19#): group A, 1 * 10^7 cells (5ml);
High dose mesenchymal stem cellsBiological
Human umbilical cord mesenchymal stem cells (SCLnow 19#): group B, 2 * 10^7 cells (5ml)
Intraarticular injectionProcedure or surgery
Intraarticular injection with human umbilical cord mesenchymal stem cells (SCLnow 19#) with different dose group
| Study group | Role | What they receive |
|---|---|---|
| Low dose mesenchymal stem cells | Experimental | Low dose group: intra-articular injection with human umbilical cord mesenchymal stem cells (SCLnow 19#) Receives: Biological: Low dose mesenchymal stem cells; Procedure: Intraarticular injection |
| High dose mesenchymal stem cells | Experimental | High dose group: intra-articular injection with human umbilical cord mesenchymal stem cells (SCLnow 19#) Receives: Biological: High dose mesenchymal stem cells; Procedure: Intraarticular injection |
| Control groups | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kellgren-Lawrence Grading Scale
Using Magnetic Resonance Imaging (MRI) examination, and based on the images of bilateral knee joint, grade by Kellgren-Lawrence Grading Scale. Kellgren-Lawrence Grading Scale is a method of classifying the severity of knee osteoarthritis (OA).
Grade 0: No radiographic features of osteoarthritis; Grade 1: Possible joint space narrowing (normal joint space is at least 2 mm at the superior acetabulum) and osteophyte formation; Grade 2: Definite osteophyte formation with possible joint space narrowing; Grade 3: Multiple osteophytes, definite joint space narrowing, sclerosis and possible bony deformity; Grade 4: Large osteophytes, marked joint space narrowing, severe sclerosis and definite bony deformity.
Measured: 12 months
Secondary outcomes (4)
Assessment of Preoperative Cartilage Defect Severity (AMADEUS)
Using Magnetic Resonance Imaging (MRI) examination to diagnose patients by Assessment of Preoperative Cartilage Defect Severity (AMADEUS).
Measured: 12 months
Lysholm scoring
Using Lysholm Knee Scoring Scale to grade the knee function of patients, and examine the changes or improvement compare to baseline.
Measured: 12 months
The international knee documentation committee (IKDC) knee evaluation form
The international knee documentation committee knee evaluation form is used to assess the knee function of patients, examine the changes or improvement compare to baseline.
Measured: 12 months
Visual Analogue Scale/Score（VAS）
Using Visual Analogue Scale/Score for pain to examine the change/improvement of knee joint function.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start1 Oct 2018
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sclnow Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hongbin Lu, Principal investigator, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383081
- Sponsor's protocol ID
- SCLnow-XY-02
- Status last verified
- Dec 2025
- First submitted
- 12 Dec 2017
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Research on the Safety/Efficacy of Human Umbilical Cord Mesenchymal Stem Cells（19#iSCLife®-OA） Therapy for Patients With Osteoarthritis
- ClinicalTrials.gov ID
- NCT03383081
- Acronym / sponsor ID
- SCLnow-XY-02
- Conditions
- Osteoarthritis, Knee
- Keywords
- osteoarthritis, mesenchymal stem cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sclnow Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Dec 2017 (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 purpose of this study is verify the efficacy and safety of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSC) therapy for patients with Osteoarthritis, and in addition, provide basis for exploring the treatment regimen of UC-MSC therapy in different degree of cartilage defect disease
Detailed description
This is a random, open label, and parallel controled experiment. All patients are selected and sign consent forms, then divided into 3 groups. Doctors collect the basic information of patient. All patients receive laboratory and image examination as baseline. Then, they will give cell treatment based on the clinical protocol. Doctors have follow-up visit on 2 weeks, 1, 2, 3, 6, and 12 months after treatment, and do safety and efficacy evaluation.
Safety evaluation. Researcher collect all examination data of patients and compare with each groups. The safety tests including blood routine, urine routine, hepatorenal function, C reactive protein, erythrocyte sedimentation rate, and tumor marker, etc.
Efficacy evaluation. Based on Lysholm, the international knee documentation committee (IKDC) knee evaluation form, and Visual Analogue Scale/Score (VAS) to examine the change/improvement of knee joint function. By Magnetic Resonance Imaging (MRI) examination, grade patients with Kellgren-Lawrence Grading Scale, Assessment of Preoperative Cartilage Defect Severity (AMADEUS), and observe the change/improvement of patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose mesenchymal stem cells | Experimental | Biological: Low dose mesenchymal stem cells, Procedure: Intraarticular injectionLow dose group: intra-articular injection with human umbilical cord mesenchymal stem cells (SCLnow 19#) |
| High dose mesenchymal stem cells | Experimental | Biological: High dose mesenchymal stem cells, Procedure: Intraarticular injectionHigh dose group: intra-articular injection with human umbilical cord mesenchymal stem cells (SCLnow 19#) |
| Control groups | No intervention | –No intervention |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of Knee Osteoarthritis by Kellgren and Lawrence Grading Scale, classified with Grade 2-3
- Confirm with cartilage injury,articular cartilage part or full-thickness injury, by MR (Magnetic Resonance)
- Age <70, no serious organ dysfunction
- Over 2 years knee pain or no very effective with conservative treatments
- Knee pain of VAS (visual analog scale score) is 4 or higher
Key exclusion criteria (18 listed)
- Refuse to sign the consent form, or cannot keep follow-up visit
- Age >70; Age <70, but with multiple organ failure
- Unstable vital signs (breath, blood pressure, pulse)
- Combined with knee ligament (anterior and the posterior cruciate ligament, medial and lateral collateral ligament) rupture, laxity, etc.
- Serious bleeding tendency, poor coagulation function (PTA <35%)
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 |
|---|---|---|
| Low dose mesenchymal stem cellsHuman umbilical cord mesenchymal stem cells (SCLnow 19#): group A, 1 * 10^7 cells (5ml); | Biological | Low dose mesenchymal stem cells |
| High dose mesenchymal stem cellsHuman umbilical cord mesenchymal stem cells (SCLnow 19#): group B, 2 * 10^7 cells (5ml) | Biological | High dose mesenchymal stem cells |
| Intraarticular injectionIntraarticular injection with human umbilical cord mesenchymal stem cells (SCLnow 19#) with different dose group | Procedure or surgery | High dose mesenchymal stem cells, Low dose mesenchymal stem cells |
Primary outcome
Kellgren-Lawrence Grading Scale
Time frame: 12 months
Using Magnetic Resonance Imaging (MRI) examination, and based on the images of bilateral knee joint, grade by Kellgren-Lawrence Grading Scale. Kellgren-Lawrence Grading Scale is a method of classifying the severity of knee osteoarthritis (OA). Grade 0: No radiographic features of osteoarthritis; Grade 1: Possible joint space narrowing (normal joint space is at least 2 mm at the superior acetabulum) and osteophyte formation; Grade 2: Definite osteophyte formation with possible joint space narrowing; Grade 3: Multiple osteophytes, definite joint space narrowing, sclerosis and possible bony deformity; Grade 4: Large osteophytes, marked joint space narrowing, severe sclerosis and definite bony deformity.
4 secondary outcomes
Assessment of Preoperative Cartilage Defect Severity (AMADEUS)
Time frame: 12 months
Lysholm scoring
Time frame: 12 months
The international knee documentation committee (IKDC) knee evaluation form
Time frame: 12 months
Visual Analogue Scale/Score（VAS）
Time frame: 12 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 4 Dec 2025.
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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.
Hongbin Lu principal investigator
Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low dose mesenchymal stem cells, High dose mesenchymal stem cells and Intraarticular injection in people with Osteoarthritis, Knee, run by Sclnow Biotechnology Co., Ltd. at 1 site 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 7 inclusion and 18 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 4 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 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Lei Guo (861064368977, georgeguo@sclnow.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kellgren-Lawrence Grading Scale (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2025.