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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Biological: allogenic amniotic fluid mesenchymal stem cell

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Bangkok Noi, Bangkok, Thailand, 10700
      • Siriraj Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AFCC injection	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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	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.	Day 0 to 7, 14, 30, Month 2 to 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	Change in pain in the affected knee joint in response to treatments using the Visual Analog Score (VAS)	Screening (Month -3), Day 0, Month 3, 6, and 12
Knee Injury and Osteoarthritis Outcome Score (KOOS)	Assessment changes of knee complaints by using the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire	Screening (Month -3), Day 0, Month 3, 6, and 12
Degree of cartilage change	Assessment change of joint narrowing space width using Radiography (X-ray) and Magnetic Resonance Imaging (MRI)	Screening (Month -3), Day 0, Month 3, and Month 12

Collaborators and Investigators

• Sponsor: Siriraj Hospital
• Investigators: Study Director: Tatsanee Phermthai, PhD., Faculty of Medicine Siriraj Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2023
• Primary Completion (Actual): November 23, 2023
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: March 29, 2024
• First Submitted That Met QC Criteria: April 25, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Knee Osteoarthritis; Amniotic fluid mesenchymal stem cells
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: R016634005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No