Study on the Safety and Tolerance of Mesenchymal Stem Cells Mediated by Arthroscopy in Patients With Osteoarthritis

NCT ID: NCT06082440

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-22
• Study Completion Date: 2026-01-10

Brief Summary

The goal of this clinical trial is to evaluate the safety and tolerability of human umbilical cord mesenchymal stem cells mediated by arthroscopy in patients with knee osteoarthritis. This experiment proposes to enroll 18-22 patients. The experimental drug is human umbilical cord mesenchymal stem cells.

Detailed Description

This study adopts a design for a single-dose increasing, single-center, randomized, placebo-controlled trial to explore the safety, tolerance and preliminary efficacy of the single-dose administration of human umbilical cord mesenchymal stem cells mediated by arthroscopy in patients with knee osteoarthritis, as well as to provide a basis for the subsequent clinical study of drug delivery plans.

The experimental process of this study is divided into four stages: screening period, baseline period, study treatment and safety observation period, follow-up period.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Human Umbilical Mesenchymal Stem Cells

Participants received a single administration for Human Umbilical Mesenchymal Stem Cells during the treatment period.The specification is 2.5 × 10\^7cells/2ml suspension/branch.

Group Type: EXPERIMENTAL

Human Umbilical Mesenchymal Stem Cells

Intervention Type: BIOLOGICAL

Ntra-articular injection inject a corresponding dose of cells suspension into each joint cavity according to the lesion site.

Interventions

Human Umbilical Mesenchymal Stem Cells

Ntra-articular injection inject a corresponding dose of cells suspension into each joint cavity according to the lesion site.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Age range from 40 to 60 years old (including threshold), regardless of gender；

2. According to the 《Chinese Guidelines for the Diagnosis and Treatment of Osteoarthritis (2021 Edition)》, patients diagnosed with knee osteoarthritis；

3. According to the imaging examination results (knee joint X-ray anterolateral axial position), the target knee joint with Kellgren Lawrence grading is classified as Grade II-III；

4. WOMAC pain sub item with a score of at least 4 points and pain lasting for at least 4 weeks from the time of signing the informed consent form；

5. Pain persists for more than six months, or after routine clinical treatment, such as hormone, opioid drugs, viscoelastic supplement therapy, etc., osteoarthritis relapses or worsens again after discontinuation of medication；

6. Those who have continuously used non-steroidal anti-inflammatory drugs for at least 12 weeks and have stabilized their dosage for at least 4 weeks before the first administration, and have maintained a stable medication regimen within 4 weeks after cell therapy；

7. All subjects and their partners who have no family planning within 6 months from screening to the end of the trial and agree to take effective non drug contraceptive measures during the trial period；

8. Those who voluntarily participate in clinical research, understand and sign an informed consent form.

Exclusion Criteria

1. Those who receive physical therapy of knee joint (bilateral or either side) or use traditional Chinese patent medicines and simple preparations to treat knee arthritis (bilateral or either side) within 6 weeks before treatment；

2. Within 3 months before the start of treatment, patients who have received topical glucocorticoid therapy on both sides or either side of the knee joint, or have received systemic glucocorticoid therapy, or who require systemic glucocorticoid therapy during the study period；

3. Individuals who have undergone knee arthroscopic surgery or other open surgeries related to knee joint operations within the first 6 months of the screening period；

4. Individuals who have received any medication injection treatment within the knee joint (bilateral or either side) cavity within 6 months before the start of treatment；

5. Patients who have received opioid therapy for knee osteoarthritis 4 weeks before the start of treatment；

6. Those who have undergone or need to undergo knee replacement surgery during the trial period；

7. Diagnosed as secondary knee osteoarthritis；

8. Patients with knee joint damage caused by other reasons, or inflammatory and painful diseases that affect the knee joint or affect the joint；

9. Other lower limb diseases that may interfere with the evaluation of knee joint efficacy, such as fibromyalgia, obvious back pain, lumbar disc herniation, etc；

10. Patients with skin disorders at the intended injection site of the target knee joint；

11. Individuals with severe systemic or local knee joint infections within the first 3 months of the screening period；

12. Individuals with solid tumors within 5 years prior to screening；

13. Individuals with severe and poorly controlled concomitant diseases；

14. Severe heart disease patients (NYHA heart function level III and above)；

15. Individuals with a clear history of mental disorders, or a history of abuse of psychotropic substances or drug use；

16. Individuals who may be allergic to any component or albumin in experimental biological products.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Wannan Medical College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qiang Wang

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Wannan Medical College

Locations

First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Weijie He

Role: CONTACT

heweijie613@163.com

15178538969

Ethics Committee of Stem cell Clinical Research Institute Wannan Medical College Yijishan Hospital IRB

Role: CONTACT

yjsyy@heweijie.com

0553-5739184

Facility Contacts

Weijie He

Role: primary

heweijie613@163.com

15178538969

Other Identifiers

QWang

Identifier Type: -

Identifier Source: org_study_id