An Early Phase 1 interventional study of Knee joint cavity injection in Primary Knee Osteoarthritis, sponsored by Beijing Hospital. Not yet recruiting. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by Beijing Hospital · Early Phase 1, Interventional, and Treatment
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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.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 621 are open to participants now.
This study's planned enrollment of 20 is below the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Beijing Hospital is the lead sponsor of 52 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Knee joint cavity injection
The control group was given 2 ml of sodium hyaluronate.The control group was given 2 ml of sodium hyaluronate.
Drug: Knee joint cavity injection
Procedure for knee joint injection: The patient lies on their back, with the knee joint flexed at 90 degrees. The knee joint is disinfected with iodine and alcohol, and a sterile sheet is laid out. The puncture point for the knee joint is selected at the inner or outer knee crease or the supra-patellar bursa approach. Using a joint cavity puncture needle (a 19-gauge needle), insert the needle vertically through the skin at the puncture point. There is a slight sense of firmness when passing through the joint capsule, and a feeling of emptiness when it is broken through. There is no resistance when injecting the fluid, and the drug can be injected.
Adverse reaction grade
Blood pressure was recorded during the transplantation process and on the 3rd, 7th, 14th and 28th days after the transplantation.
Time frame: From the beginning of the treatment to 28 days after the treatment.
Adverse reaction grade
During the transplantation process and on the 3rd, 7th, 14th and 28th days after transplantation, record the heart rate.
Time frame: From the beginning of the treatment to 28 days after the treatment.
Adverse reaction grade
During the transplantation process and on the 3rd, 7th, 14th and 28th days after transplantation, record the body temperature.
Time frame: From the beginning of the treatment to 28 days after the treatment.
Adverse reaction grade
During the transplantation process and on the 3rd, 7th, 14th and 28th days after transplantation, observe whether any rash occurs.
Time frame: From the beginning of the treatment to 28 days after the treatment.
Clinical effectiveness
patient pain score (VAS score)： 0 point: Completely pain-free, no discomfort. 1-3 points (mild): There is pain, but it does not affect sleep or daily activities and can be tolerated; 4-6 points (moderate): Severe pain that significantly affects sleep, requiring distraction to cope with it, and usually requiring medication intervention; 7-10 points (severe): Significantly interferes with daily life, unbearable, may result in inability to move or sleep, requires strong pain relief.
Time frame: From the beginning of the treatment to two years after the treatment
Clinical effectiveness
joint function score (KSS score) Including clinical scores and functional scores.
Time frame: From the beginning of the treatment to two years after the treatment
Clinical effectiveness
quality of life score (SF-12)
Time frame: From the beginning of the treatment to two years after the treatment
Clinical effectiveness
WORMS score
Time frame: From the beginning of the treatment to two years after the treatment
No study locations are listed for this record.
Plan to share: Yes
Supporting information: Clinical study report
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Dec 2028, 25 months later.
Of 61 phase 1 interventional studies under Osteoarthritis, Knee, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 25 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Beijing Hospital