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

Siriraj Hospital10 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Knee Osteoarthritis

Interventions

allogenic amniotic fluid mesenchymal stem cellBIOLOGICAL

Intra-articular AFCC injection will be given for single knee for each patient in single dose, 20 million of AFCC in each dose

Eligibility

Sex: ALLMin age: 60 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Locations (1)

Siriraj Hospital

Bangkok Noi, Bangkok, Thailand

Outcomes

Primary Outcomes

Incidence of abnormal physical examination

The following examinations will be conducted: general appearance, respiratory, abdomen, nervous system, muscoskeletal system and etc. In case of abnormal conditions, they shall be recorded as an adverse event.

Time frame: Month -3, Day 0, Month 3, 6 and 12

Incidence of abnormal vital sign

The following assessment will be conducted: heart rate, blood pressure and temperature. In case of abnormal results, they shall be record as an adverse event.

Time frame: Month -3, Day 0, Month 3, 6 and 12

Incidence of abnormal laboratory test results

The following lab tests will be conducted: serum chemistry, haematology, liver function test. In case of abnormal results, they shall be recorded as an adverse event.

Time frame: Day 0, Month 3, 6 and 12

Incidence of abnormal ECG parameters

The following assessments will be conducted: 12 lead ECG recordings with long Lead II, and two-dimensional echocardiography (2D ECHO; if needed). In case of abnormal conditions, they shall be recorded as an adverse event

Time frame: Day 0, Month 3, 6 and 12

The type of Adverse event (AE), numbers of AE and proportion of patients with AE.

AE will be monitored and recorded by the investigator throughout the study.

Time frame: Day 0 to 7, 14, 30, Month 2 to 12

Secondary Outcomes

Pain score

Change in pain in the affected knee joint in response to treatments using the Visual Analog Score (VAS)

Time frame: Screening (Month -3), Day 0, Month 3, 6, and 12

Data from ClinicalTrials.gov

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