Intracapsular Injection of Human Umbilical Cord Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis (KOA UC-MSCs)

Evaluating the Efficacy of Intra-articular Injection of Human Umbilical Cord Mesenchymal Stem Cells for Treating Knee Osteoarthritis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Knee Osteoarthritis
• Intervention / Treatment: Drug: Knee joint cavity injection

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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;

Exclusion Criteria:

• Those who have received joint cavity injection treatment within 3 months;
• 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 immunodeficiency or who have received immunosuppressive treatment within 12 weeks;
• Those with other serious diseases that cannot cooperate with the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment group; 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; 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.
Placebo Comparator: control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse reaction grade	Blood pressure was recorded during the transplantation process and on the 3rd, 7th, 14th and 28th days after the transplantation.	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.	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.	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.	From the beginning of the treatment to 28 days after the treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	From the beginning of the treatment to two years after the treatment
Clinical effectiveness	quality of life score (SF-12)	From the beginning of the treatment to two years after the treatment
Clinical effectiveness	WORMS score	From the beginning of the treatment to two years after the treatment

Collaborators and Investigators

• Sponsor: Beijing Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 20, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: August 11, 2026
• First Submitted That Met QC Criteria: November 6, 2026
• First Posted (Actual): November 13, 2026

Study Record Updates

• Last Update Posted (Actual): November 13, 2026
• Last Update Submitted That Met QC Criteria: November 6, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: knee osteoarthritis (KOA); human umbilical cord mesenchymal stem cells (hUC-MSCs)
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 2026BJYYEC-XJS001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No