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

Last updated: January 2, 2024
Sponsor: First Affiliated Hospital of Wannan Medical College
Overall Status: Active - Recruiting

Phase

1

Condition

Osteoarthritis

Treatment

Human Umbilical Mesenchymal Stem Cells

Clinical Study ID

NCT06082440
QWang
  • Ages 40-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 axialposition), the target knee joint with Kellgren Lawrence grading is classified as GradeII-III;
  4. WOMAC pain sub item with a score of at least 4 points and pain lasting for at least 4weeks from the time of signing the informed consent form;
  5. Pain persists for more than six months, or after routine clinical treatment, such ashormone, opioid drugs, viscoelastic supplement therapy, etc., osteoarthritis relapsesor worsens again after discontinuation of medication;
  6. Those who have continuously used non-steroidal anti-inflammatory drugs for at least 12weeks and have stabilized their dosage for at least 4 weeks before the firstadministration, and have maintained a stable medication regimen within 4 weeks aftercell therapy;
  7. All subjects and their partners who have no family planning within 6 months fromscreening to the end of the trial and agree to take effective non drug contraceptivemeasures during the trial period;
  8. Those who voluntarily participate in clinical research, understand and sign aninformed consent form.

Exclusion

Exclusion Criteria:

  1. Those who receive physical therapy of knee joint (bilateral or either side) or usetraditional 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 topicalglucocorticoid therapy on both sides or either side of the knee joint, or havereceived systemic glucocorticoid therapy, or who require systemic glucocorticoidtherapy during the study period;
  3. Individuals who have undergone knee arthroscopic surgery or other open surgeriesrelated 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 thestart of treatment;
  6. Those who have undergone or need to undergo knee replacement surgery during the trialperiod;
  7. Diagnosed as secondary knee osteoarthritis;
  8. Patients with knee joint damage caused by other reasons, or inflammatory and painfuldiseases that affect the knee joint or affect the joint;
  9. Other lower limb diseases that may interfere with the evaluation of knee jointefficacy, 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 3months 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 ofpsychotropic substances or drug use;
  16. Individuals who may be allergic to any component or albumin in experimental biologicalproducts.

Study Design

Total Participants: 18
Treatment Group(s): 1
Primary Treatment: Human Umbilical Mesenchymal Stem Cells
Phase: 1
Study Start date:
November 22, 2023
Estimated Completion Date:
January 10, 2026

Study 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.

Connect with a study center

  • First Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui 241000
    China

    Active - Recruiting

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