NCT06386679

Amniotic Fluid Mesenchymal Stem Cells Developed for Chondrogenic Treatment (AFCC) Injection in Elderly Knee Osteoarthritis Patients

A Pilot Study: Safety and Efficacy of Allogenic Mesenchymal Stem Cell Type AFCC for Treating in Elderly Knee Osteoarthritis Patients

• Status: Enrolling By Invitation
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Siriraj Hospital · Academic / Other
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Amniotic fluid mesenchymal stem cells developed for chondrogenic treatment (AFCC) are used to treat elderly patients suffering from knee osteoarthritis (OA). The injection reduces inflammation and promotes the recovery of knee function, leading to an improved quality of life.

Detailed description

Ten patients, aged between 60 and 80 of both genders, who were diagnosed with knee osteoarthritis at Kellgren and Lawrence (KL) score 2-3 were selected based on strict inclusion and exclusion criteria. Each patient was treated with a single intra-articular injection of 20 million cells of amniotic fluid mesenchymal stem cells in AFCC type into an OA knee. After the treatment, they were monitored through clinical assessment and laboratory investigation, including blood chemistry test and Magnetic Resonance Imaging (MRI) of the treated knee.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
BIOLOGICAL	allogenic amniotic fluid mesenchymal stem cell	Intra-articular AFCC injection will be given for single knee for each patient in single dose, 20 million of AFCC in each dose

Timeline

• Start date: 2023-08-17
• Primary completion: 2023-11-23
• Completion: 2025-03-01
• First posted: 2024-04-26
• Last updated: 2024-04-26

Locations

1 site across 1 country: Thailand