A comparative study between adipocyte-derived mesenchymal stem cell versus intra-articular hyaluronic acid interventions in early osteoarthritis: Prospective Randomized Open, Blinded End-point

Phase 2

Completed

• Conditions: Patients with symptomatic knee osteoarthritis at Kellgren & Lawrence stage II; Knee osteoarthritis; Adipocyte-derived mesenchymal stem cells; Stem cell therapy; Regenerative medicine

• Registration Number: TCTR20230929002
• Lead Sponsor: ational Research Council of Thailand (NRCT)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-05-27
• Study Start: 2023-09-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Patients with symptomatic knee osteoarthritis at Kellgren & Lawrence stage II that discontinued the use of nonsteroidal anti-inflammatory drugs (NSAIDs) for at least 2 weeks

Exclusion Criteria

1. Patients with secondary osteoarthritis.
2. Patients with a history of significant trauma, such as fractures of the knee and malformation of the bones.
3. Patients with cancer.
4. Patients with swollen, red, or hot knees.
5. Patients experiencing worsening pain or side effects from the procedure.
6.Patients with diabetes (DM), immunocompromised conditions.
7. Patients who have previously received stem cell therapy.
8. Patients with abnormal blood clotting or taking anticoagulant medications.
9. Pregnant women and breastfeeding mothers.
Please note that this revision clarifies the criteria for selecting and excluding participants in the randomized controlled trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical improvement 0,1,3,6 month WOMAC score

Secondary Outcome Measures

Name	Time	Method
radiographic improvement 0,1,3,6 month MRI ultrasound