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

Siriraj Hospital

Status and phase: Invitation-only; Phase 1

Conditions: Knee Osteoarthritis

Treatments: Biological: allogenic amniotic fluid mesenchymal stem cell

Study type: Interventional

Funder types: Other

Identifiers

NCT06386679

R016634005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age between 60 to 80 years
2. The Visual Analog Scale (VAS) score of the subject's knee joint was greater than 4
3. Knee pain needs at least 15 days of experience.
4. The Kellgren Lawrence grade of the subject's knee joint was II/III as per the axial position X-ray.
5. Subjects who understand and voluntarily sign the consent.

Exclusion criteria

1. The subject has secondary osteoarthritis (such as other joint arthritis, major trauma on the study joint in the previous 3 months, axial deviation angle beyond 15 degrees of the bones of the knee joint)
2. The subject has other known rheumatic or inflammatory diseases (such as rheumatoid arthritis and inflammatory arthritis).
3. The subject has other conditions that cause knee joint pain (such as cancer, joint tumor)
4. The subject who awaiting knee surgery
5. The subject has an underlying disease that affects treatment during 1 year (such as cancer, liver disease, severe kidney disease, SLE)
6. The subject has a history of vertebral fracture or leg bone fracture
7. The subject has a nervous system disorder that affects balance (such as stroke or Parkinson's disease)
8. The subject has an acute or chronic infectious disease
9. The subject who had evidence of knee surgery
10. The subject who has received intra-articular steroids or other substances within the last 6 months.
11. The subject who has received symptomatic slow-acting drugs for osteoarthritis (SYSADOA) within the last 4 months
12. The subject has a deformity of the knee joint.
13. The subject has any other pathological conditions
14. The subject has a communication problem
15. The subject has claustrophobia
16. The subject who had surgery to insert a cardiac pacemaker
17. The subject who had surgery to insert an aneurysm clip
18. The subject who had surgery to insert a cochlear implant
19. The subject has any internal metallic objects (such as metal plates, surgical clips, bullets)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

AFCC injection

Experimental group

Treatment:

Biological: allogenic amniotic fluid mesenchymal stem cell