The safety, tolerability, and preliminary efficacy of CAStem injection intravenously injected into the knee for meniscus injury in Chinese subjects

• Register: ChiCTR
• Last refreshed on: 9 October 2023
• Main ID: ChiCTR2200057251
• Date of registration: 2022-03-04
• Prospective Registration: No
• Primary sponsor: Peking University Peoples Hospital
• Public title: The safety, tolerability, and preliminary efficacy of CAStem injection intravenously injected into the knee for meniscus injury in Chinese subjects
• Scientific title: Clinical trial of CAStem injection in treatment of meniscus injury
• Date of first enrolment: 2022-02-21
• Target sample size: treatment group:18;placebo group:6;
• Recruitment status: Pending
• URL: https://www.chictr.org.cn/showproj.html?proj=153057
• Study type: Interventional study
• Study design: Dose comparison
• Phase: 1-2

Countries of recruitment

China

Contacts

• Name: Jiwen Song
• Affiliation: Zephyrm Biotechnologies

• Name: Yi Jia
• Affiliation: Zephyrm Biotechnologies

Key inclusion & exclusion criteria

Inclusion criteria: 1. Chinese male or female, age >= 18 and <= 65 years;
2. Before signing the informed consent, the knee symptoms were more than 3 months old, but the symptoms still existed after conservative treatment, and the researcher judged that there was no evidence of surgical treatment. Knee symptoms include at least one of the following: popping, clagging, joint instability, feeling of slapping or slipping, pain associated with joint rotation, motion, or torsion, acute parparal pain limited to one facet, joint locking, and intermittent swelling;
3. Grade I-III meniscus injury was confirmed by MRI examination (Stoller scale);
4. Signed written informed consent;
5. Be able and willing to comply with the requirements of the clinical trial protocol, follow the medication and treatment restrictions specified in this protocol, and be able to complete all study visit procedures and subject report evaluations as required.
Exclusion criteria: 1. Received previous cell injection therapy;
2. Within 2 months before signing the informed consent, the knee joint on the test side received intraarticular hyaluronic acid, platelet rich plasma or other drug injection; During the 2 weeks prior to signing the informed consent, acupuncture or acupoint therapy was performed on the test side of the knee;
3. The test side knee has undergone knee surgery or arthroscopy or the opposite side knee has undergone knee surgery or arthroscopy within 24 weeks prior to signing the informed consent, or either side of the knee is scheduled to undergo surgery or arthroscopy during the period of this study;
4. Congenital/acquired knee malformation (e.g. Varus or valus dislocation > 10 degrees), meniscus malformation, knee ligament tear, bone and muscle injury on either side of the lower limb, and the researcher determined that the patient was not suitable for the study;
5. Bilateral meniscus injury was diagnosed at the same time (lesion classification was based on MRI Stoller grading criteria) and both knee joint pain and/or functional limitations were present;
6. Diagnosis of severe knee osteoarthritis in either knee (i.e. Kellgren-lawrence grade III or Grade IV);
7. Patients with venous or lymphatic disease or peripheral vascular disease or claudication of lower limbs are judged by researchers to be unsuitable for this study;
8. Chronic pain conditions, including but not limited to hip pain, disc herniation, sciatica, diabetic neuropathy, etc.;
9. The knee joint of the test side had symptoms of infection or skin infection of the knee joint, so the researcher judged that it was not suitable for the knee joint intravascular injection;
10. Patients have an autoimmune disease or immune deficiency disease or long-term use of immunosuppressants;
11. Poor coagulation function or severe bleeding tendency or current active bleeding or bleeding disease or the patient is receiving anticoagulant or antiplatelet therapy and cannot stop receiving injection (namely, anticoagulant drugs should be stopped 3 days before injection and 3 days after injection), and the operation of cell implantation will be affected according to the judgment of the researcher;
12. Patients with past serious arrhythmia, or serious acute cardiovascular and cerebrovascular events, or serious abnormality of heart function, or abnormality of lung function, who were judged by the investigator to be unfit to participate in this clinical trial;
13. Patients with poorly controlled hypertension or diabetes, or impaired liver function, or renal function, or other diseases that are deemed inappropriate to participate in this clinical trial by the investigator;
14. Active infectious diseases, including but not limited to hepatitis b surface antigen (HBVsAg) positive and hepatitis B virus DNA test positive, hepatitis C virus RNA (HCV-RNA) or human immunodeficiency virus (HIV) antibody positive, or syphilis in the infectious stage, and other patients with active infectious diseases that the investigator deems inappropriate to participate in the study;
15. Alcohol or drug addiction;
16. Patients had severe vestibular and balance dysfunction and was judged by the investigator to be inappropriate to participate in the clinical trial;
17. History of malignant tumor or pathological evidence of severe atypical hyperplasia;
18. Patients with contraindications of MRI examination and ferromagnetic metal foreign bodies, such as cardiac implantable

Age minimum: 18
Age maximum: 65
Gender: Both

Health Condition(s) or Problem(s) studied

meniscus injury

Intervention(s)

treatment group:Intra-articular injection;placebo group:Intra-articular injection;

Primary Outcome(s)

Safety;

Secondary Outcome(s)

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) -physical function score;Knee Injury and Osteoarthritis Outcome Score;SF-36 quality of life score;Imaging evaluation(MRI);

Source(s) of Monetary Support

sponsor(Zephyrm Biotechnologies)

Ethics review

Status: Approved
Approval date: 07/01/2022
Contact: