Dear Patient,
The Department of Orthopedics at our hospital is conducting a multicenter, randomized, double‑blind, parallel‑controlled Phase II clinical trial titled “Human Umbilical Cord Mesenchymal Stem Cell Injection for the Treatment of Knee Osteoarthritis” (Protocol No. SLL‑201). This study compares the investigational product with Dinggan Cross‑linked Sodium Hyaluronate Injection, aiming to explore the efficacy, optimal dose, and administration frequency of human umbilical cord mesenchymal stem cell injection in treating knee osteoarthritis, as well as to evaluate its safety.
The study has been approved by the National Medical Products Administration (Clinical Trial Approval No. 2021LP01535) and the Clinical Trial Ethics Committee of West China Hospital, Sichuan University.
All study‑required examination costs and study drugs will be covered by the sponsor, Guangzhou Saliai Stem Cell Science and Technology Co., Ltd. You will not incur any additional expenses by participating in this study.
Enrollment Criteria
If your doctor confirms that you meet the following inclusion criteria and you provide your consent, you are welcome to join the study.
Age 40‑75 years (inclusive), any gender;
Diagnosed with knee osteoarthritis according to the Chinese Guidelines for the Diagnosis and Treatment of Osteoarthritis (2018 Edition) by the Joint Surgery Group of the Orthopedics Branch of the Chinese Medical Association (meeting the primary criterion plus any two of the other four):
Recurrent knee pain in the past month;
X‑ray (standing or weight‑bearing) showing joint space narrowing, subchondral bone sclerosis and/or cysts, and/or osteophyte formation at joint margins;
Age ≥ 50 years;
Morning stiffness ≤ 30 minutes;
Crepitus (grating sensation) during movement;
Kellgren‑Lawrence grade II‑III of the target knee joint based on imaging (X‑ray anteroposterior and lateral views);
WOMAC pain score of 20‑42.5 cm and total WOMAC score of 60‑180 cm for the target knee before randomization (defined as WOMAC score measured at least 48 hours after discontinuation of all analgesic drugs).
Contact Information
If you are interested in this study or wish to learn more, please contact the study coordinator:
Contact: Wu
Phone: 86 18284506280
