Intracapsular Injection of Human Umbilical Cord Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis
Key facts
- Who runs it
- Beijing Hospital
- Trial code
- Status
- Not yet recruiting
- Phase
- Early phase 1
- People taking part
- 20 people, planned
- Starts
- 20 Nov 2026
- Expected to end
- 31 Dec 2029
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Knee joint cavity injection
- Record updated
- 13 November 2026
Who can take part
- Age
- 45 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- Patients with primary knee osteoarthritis aged between 45 and 75 years old
- The X-ray of the bilateral knee joints shows a KL grade of 2-3 for both knees, and the grades of the bilateral knee joints are consistent
- The difference in knee pain VAS score between both knees is no more than 2 points
Who cannot take part
- Those who have received joint cavity injection treatment within 3 months
- Those with immunodeficiency or who have received immunosuppressive treatment within 12 weeks
- Those who have experienced knee joint infection within 12 weeks, or knee joint injury within 12 weeks
- Rheumatoid arthritis and other autoimmune joint diseases
- Those with digestive tract ulcers, coronary heart disease and other conditions where the use of non-steroidal anti-inflammatory drugs is contraindicated
- Those with tumors, diabetes, blood system diseases, local skin diseases and systemic allergies
- Those with other serious diseases that cannot cooperate with the study
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 45 and 75 years old?
About the trial
What the trial wants to find out
This is a self-controlled study comparing both knees. A total of 20 participants are planned to be enrolled. Among the first 10 participants, the same patient received 50 million mesenchymal stem cells and 2 ml of hyaluronic acid solution mixture in one knee as the experimental group, while the other knee was treated with 2 ml of hyaluronic acid injection solution as the control group. The first 10 patients did not experience any serious adverse events. After re-enrollment of the next 10 patients, the same patient was given 100 million mesenchymal stem cells and 2 ml of hyaluronic acid sodium mixture to one knee, while the other knee was given 2 ml of hyaluronic acid sodium injection as the experimental group. Compare the therapeutic effects between the two knees and among different doses.
The 2 groups in the trial
- treatment groupTreatment being tested
First, 10 subjects were enrolled. For one knee joint of each subject, a mixture of 5 million HUCMSCs and 2 ml of sodium hyaluronate was administered as the experimental group. If no serious adverse reactions occurred among the first 10 patients, the remaining 10 subjects were enrolled, and the other knee joint of each subject was treated with 100 million HUCMSCs and 2 ml of sodium hyaluronate as the experimental group.
Treatment: Knee joint cavity injection
- control groupPlacebo, for comparison
The control group was given 2 ml of sodium hyaluronate.The control group was given 2 ml of sodium hyaluronate.
Treatment: Knee joint cavity injection
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evaluating the Efficacy of Intra-articular Injection of Human Umbilical Cord Mesenchymal Stem Cells for Treating Knee Osteoarthritis
- Fit questions
- Built from NCT07935083, who can take part
- Record updated
- 13 November 2026