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A multIcentre, randomized, double blind, controlled trial for safety and efficacy of BL173-hUMSCs in the treatment of osteoarthritis

A multIcentre, randomized, double blind, controlled trial for safety and efficacy of BL173-hUMSCs in the treatment of osteoarthritis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017713
Enrollment
Unknown
Registered
2018-08-10
Start date
2018-09-01
Completion date
Unknown
Last updated
2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Interventions

B:human Umbilical Cord -Mesenchymal Stem Cells group

Sponsors

Renji Hospital Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. The subjects or his/her legal representative voluntarily accepts the treatment and signs the informed consent; 2. According to the diagnostic criteria, the patient was clearly diagnosed with osteoarthritis of the knee; 3. Subjects are aged from 18 to 70 years old male and female; 4. The clinical course of knee arthritis was more than 6 months and less than 10 years; 5. The VAS score was more than 6 and less than 8; 6. The K-L score was lower than Grade 4; 7. Subjects are able to walk autonomously.

Exclusion criteria

Exclusion criteria: 1. Subjects are allergic to one or more medicines or to two or more foods; 2. Subjects' height and weight index (BMI) was more than 30; 3. The subject suffers from uncontrollable or uncontrollable cardiovascular and cerebrovascular, liver, kidney, lung, endocrine and other systematic diseases; 4. The subject has a history of malignancy; 5. Subjects were associated with systemic or rheumatic arthritis chondrosis, articular cartilage calcinosis, hemochromatosis, inflammatory arthropathy, ischemic necrosis of femoral head, Paget's disease, haemophilic arthropathy , infectious arthritis, Charcot's disease, villous synovitis, synovial chondromatosis; 6. Within 3 months before the start of the study, the subject has a relatively serious systemic or local knee infection (including skin and lumen infection); 7. Subjects have lower limb diseases that can interfere with knee assessment, such as fibromyalgia, more obvious lower back pain, and lumbar disc herniation; 8. The subject has coagulation disorder; 9. Subjects receivedc knee arthroscopic surgery or other open surgery related to knee joint operation within 6 months before the study begins; 10. Subjects received intra-articular drug injection for knee osteoarthritis within 6 months before the start of the study, including but not limited to hyaluronic acid, hormone, PRP, BMP, etc.; 11. Subjects received glucosamine and/or chondroitin sulfate treatment within 4 weeks prior to the start of the study; 12. Subjects will undergo knee replacement during the observation period; 13. Subjects had contraindications for MRI examination; 15. The subjects were infected with HIV, hepatitis virus and syphilis; 16. Subjects had alcoholism, drug abuse or mental illness within 3 years before the study; 17. Subjects will participate in any other clinical study within 3 months before the study; 18. The subject is gestation or nursing or intends to conceive for the last six months; 19. Other conditions considered inappropriate for the study were determined by the researchers.

Design outcomes

Primary

MeasureTime frame
X-ray;Nuclear Magnetic Resonance Imaging;VAS score;WOMAC score;

Countries

China

Contacts

Public ContactLiangjing Lv

Renji Hospital Shanghai Jiaotong University School of Medicine

Lu_liangjing@medmail.com.cn+86 13661472001

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026