Clinical trial NCT06386679: Amniotic Fluid Mesenchymal Stem Cells Developed for Chondrogenic Treatment (AFCC) Injection in Elderly Knee Osteoarthritis Patients
Official title: A Pilot Study: Safety and Efficacy of Allogenic Mesenchymal Stem Cell Type AFCC for Treating in Elderly Knee Osteoarthritis Patients
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: Knee Osteoarthritis
Keywords: Amniotic fluid mesenchymal stem cells
Knee Osteoarthritis
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 10
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Ten elderly patients from both gender diagnosed with knee osteoarthritis, will be enrolled according to specific inclusion and exclusion criteria. These patients will be injected with amniotic fluid mesenchymal stem cells developed for chondrogenic treatment. Then, they are followed by clinical assessment, laboratory investigations as well as magnetic resonance imaging (MRI) of the injected knee.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Incidence of abnormal physical examination
timeFrame: Month -3, Day 0, Month 3, 6 and 12
measure: Incidence of abnormal vital sign
timeFrame: Month -3, Day 0, Month 3, 6 and 12
measure: Incidence of abnormal laboratory test results
timeFrame: Day 0, Month 3, 6 and 12
measure: Incidence of abnormal ECG parameters
timeFrame: Day 0, Month 3, 6 and 12
measure: The type of Adverse event (AE), numbers of AE and proportion of patients with AE.
timeFrame: Day 0 to 7, 14, 30, Month 2 to 12
Secondary outcomes:
measure: Pain score
timeFrame: Screening (Month -3), Day 0, Month 3, 6, and 12
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Screening (Month -3), Day 0, Month 3, 6, and 12
measure: Degree of cartilage change
timeFrame: Screening (Month -3), Day 0, Month 3, and Month 12
Other outcomes:
Locations:
city: Bangkok Noi
country: Thailand
facility: Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Siriraj Hospital
name: Tatsanee Phermthai, PhD.
role: STUDY_DIRECTOR
References: