Knee OsteoarthritisNCT05160831
Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Knee Osteoarthritis
A study testing Human umbilical cord mesenchymal stem cells in people with Knee Osteoarthritis, run by Southwest Hospital, China.
Trial summary
This study aims to investigate the effectiveness and safety of human umbilical cord mesenchymal stem cell injection in the articular cavity to treat moderate to severe knee osteoarthritis (OA), and whether it can achieve articular cartilage regeneration, reduction of joint pain, and restoration of joint function. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Human umbilical cord mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2022to 20 Jan 2024
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have no major organ dysfunction.
- Diagnosed as moderate to severe knee osteoarthritis according to internationally recognized criteria: a). Meets the criteria of the "Guidelines for the Diagnosis and Treatment of Osteoarthritis (2018 Edition)" revised by the Chinese Medical Association Rheumatology Branch in 2018; b). Meets the criteria of Grade 3 or more according to the American College of Rheumatology (ACR); c).Meets the criteria of Grade Ⅲ or more according to Kellgren-Lawrence's OA radiology grading standard.
- Those who have the ability to move independently, except those who use wheelchairs, walkers or crutches, and who have no history of mental illness.
- There is no obvious contraindication to articular cavity injection in hematology and biochemical testing.
- No local or systemic infection.
- Subjects and their families understand the clinical trial protocol and agree to participate in the trial, and sign a written Informed Consent.
- Patients whose pain has lasted for more than half a year, and the routine clinical treatment of oral hormones, opioids and other drugs have been ineffective.
Who cannot join
- Those who are older than 70 years old or younger than 18 years old, or have no full capacity for civil conduct.
- HIV, hepatitis virus or syphilis virus infection or positive serological test.
- Body mass index (BMI) greater than 30 kg/m2.
- Congenital or acquired knee deformity; severe knee arthritis accompanied by severe varus deformity, with varus greater than 10°.
- Pregnant or lactating women, or women of childbearing age who have a positive pregnancy test within 7 days before receiving treatment.
- Complicated with severe cardiovascular and cerebrovascular, liver, kidney, and endocrine, blood system diseases, malignant tumors, allergies, mental disorders, acute infections or local knee joint infections.
Show all 10Show fewer
- Patients with immunodeficiency.
- Patients with a history of intra-articular injection within 3 months; patients being treated with immunosuppressive agents and glucocorticoids.
- Patients who are still participating in other clinical trials.
- Subjects who refuse to sign Informed Consent or refuse to participate in this clinical trial.
Trial locations and contacts
No sites are listed yet.
About this study
This study aims to investigate the effectiveness and safety of human umbilical cord mesenchymal stem cell injection in the articular cavity to treat moderate to severe knee osteoarthritis (OA), and whether it can achieve articular cartilage regeneration, reduction of joint pain, and restoration of joint function.
Read the detailed description
There are more than 100 types of arthritis, and the most common ones are rheumatoid arthritis (RA) and osteoarthritis (OA). The main cause of its pathogenesis is the compensatory hyperplasia of the articular cartilage caused by the body's degenerative changes, which will eventually cause the joint to partially or completely lose its function.
In the past few decades, continuous efforts have been made to treat OA. The treatment of OA changes with the development of the patient's condition. At present, there are many diagnosis and treatment options for knee OA, including conservative treatment and surgical treatment. There is an urgent need for an effective treatment to postpone or terminate the course of OA.
Cell therapy for OA has developed rapidly in recent years and has received widespread attention. Mesenchymal stem cells (MSCs) are pluripotent stem cells with potential of self-renewal, proliferation and differentiation. Stem cells are extracted from the patient's body and then implanted back. Their ability of regeneration and reproduction can fill the damaged cartilage tissue, so as to achieve an effective treatment of the joint damage.
This study aims to investigate the effectiveness and safety of human umbilical cord mesenchymal stem cell injection in the articular cavity to treat moderate to severe knee osteoarthritis (OA), and whether it can achieve articular cartilage regeneration, reduction of joint pain, and restoration of joint function.
- Conditions
- Knee Osteoarthritis
- Being tested
- Human umbilical cord mesenchymal stem cells
- Keywords
- knee joint, osteoarthritis, human umbilical cord mesenchymal stem cells
- 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.
Human umbilical cord mesenchymal stem cellsBiological
Human umbilical cord mesenchymal stem cell injection is applied for treating knee OA patients.
| Study group | Role | What they receive |
|---|---|---|
| Human umbilical cord mesenchymal stem cells | Experimental | Human umbilical cord mesenchymal stem cells injection is applied for knee OA patients. Receives: Biological: Human umbilical cord mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score
Changes of Visual Analogue Scale (VAS) score after injection
Measured: 1, 3, 6, 12 months after injection
Secondary outcomes (1)
Kellgren-Lawrence score
Changes of Kellgren-Lawrence Score
Measured: 1, 3, 6, 12 months after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start20 Jan 2022 (estimated)
- Primary completion20 Jan 2023 (estimated)
- Study completion20 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Yang, MD, Southwest Hospital, China
- Investigators
- Liu Yang, MD, Principal investigator, Center for Joint Surgery, Southwest Hospital, ChinaFuyou Wang, MD, Principal investigator, Center for Joint Surgery, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160831
- Sponsor's protocol ID
- SCforKneeOA
- Status last verified
- Dec 2021
- First submitted
- 6 Dec 2021
- Last updated
- 16 Dec 2021
- 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 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05160831
- Acronym / sponsor ID
- SCforKneeOA
- Conditions
- Knee Osteoarthritis
- Keywords
- knee joint, osteoarthritis, human umbilical cord mesenchymal stem cells
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- 20 Jan 2022 (estimated)
- Primary completion
- 20 Jan 2023 (estimated)
- Study completion
- 20 Jan 2024 (estimated)
- First posted
- 16 Dec 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.
This study aims to investigate the effectiveness and safety of human umbilical cord mesenchymal stem cell injection in the articular cavity to treat moderate to severe knee osteoarthritis (OA), and whether it can achieve articular cartilage regeneration, reduction of joint pain, and restoration of joint function.
Detailed description
There are more than 100 types of arthritis, and the most common ones are rheumatoid arthritis (RA) and osteoarthritis (OA). The main cause of its pathogenesis is the compensatory hyperplasia of the articular cartilage caused by the body's degenerative changes, which will eventually cause the joint to partially or completely lose its function.
In the past few decades, continuous efforts have been made to treat OA. The treatment of OA changes with the development of the patient's condition. At present, there are many diagnosis and treatment options for knee OA, including conservative treatment and surgical treatment. There is an urgent need for an effective treatment to postpone or terminate the course of OA.
Cell therapy for OA has developed rapidly in recent years and has received widespread attention. Mesenchymal stem cells (MSCs) are pluripotent stem cells with potential of self-renewal, proliferation and differentiation. Stem cells are extracted from the patient's body and then implanted back. Their ability of regeneration and reproduction can fill the damaged cartilage tissue, so as to achieve an effective treatment of the joint damage.
This study aims to investigate the effectiveness and safety of human umbilical cord mesenchymal stem cell injection in the articular cavity to treat moderate to severe knee osteoarthritis (OA), and whether it can achieve articular cartilage regeneration, reduction of joint pain, and restoration of joint function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Human umbilical cord mesenchymal stem cells | Experimental | Biological: Human umbilical cord mesenchymal stem cellsHuman umbilical cord mesenchymal stem cells injection is applied for knee OA patients. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who have no major organ dysfunction.
- Diagnosed as moderate to severe knee osteoarthritis according to internationally recognized criteria: a). Meets the criteria of the "Guidelines for the Diagnosis and Treatment of Osteoarthritis (2018 Edition)" revised by the Chinese Medical Association Rheumatology Branch in 2018; b). Meets the criteria of Grade 3 or more according to the American College of Rheumatology (ACR); c).Meets the criteria of Grade Ⅲ or more according to Kellgren-Lawrence's OA radiology grading standard.
- Those who have the ability to move independently, except those who use wheelchairs, walkers or crutches, and who have no history of mental illness.
- There is no obvious contraindication to articular cavity injection in hematology and biochemical testing.
- No local or systemic infection.
Key exclusion criteria (10 listed)
- Those who are older than 70 years old or younger than 18 years old, or have no full capacity for civil conduct.
- HIV, hepatitis virus or syphilis virus infection or positive serological test.
- Body mass index (BMI) greater than 30 kg/m2.
- Congenital or acquired knee deformity; severe knee arthritis accompanied by severe varus deformity, with varus greater than 10°.
- Pregnant or lactating women, or women of childbearing age who have a positive pregnancy test within 7 days before receiving treatment.
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 |
|---|---|---|
| Human umbilical cord mesenchymal stem cellsHuman umbilical cord mesenchymal stem cell injection is applied for treating knee OA patients. | Biological | Human umbilical cord mesenchymal stem cells |
Primary outcome
VAS score
Time frame: 1, 3, 6, 12 months after injection
Changes of Visual Analogue Scale (VAS) score after injection
1 secondary outcome
Kellgren-Lawrence score
Time frame: 1, 3, 6, 12 months after injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
Related trials for Knee Osteoarthritis
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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.
Liu Yang, MD principal investigator
Center for Joint Surgery, Southwest Hospital, China
Fuyou Wang, MD principal investigator
Center for Joint Surgery, Southwest Hospital, China
Questions about this trial
What is this clinical trial studying?
A study testing Human umbilical cord mesenchymal stem cells in people with Knee Osteoarthritis, run by Southwest Hospital, 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 10 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 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fuyou Wang, MD (86-23-68765290, arthro@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS score (time frame: 1, 3, 6, 12 months after injection). 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 16 Dec 2021; AzTrials last refreshed its copy on 8 Nov 2026.