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

NCT06386679 | Enrolling By Invitation Phase 1

• 1 other identifier: R016634005
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Amniotic fluid mesenchymal stem cells; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Pain score

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

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

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

• Degree of cartilage change

  Screening (Month -3), Day 0, Month 3, and Month 12

Study Arms (1)

AFCC injection

EXPERIMENTAL

Biological: allogenic amniotic fluid mesenchymal stem cell

Interventions

allogenic amniotic fluid mesenchymal stem cell BIOLOGICAL

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

AFCC injection

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)
• The subject has other known rheumatic or inflammatory diseases (such as rheumatoid arthritis and inflammatory arthritis).
• The subject has other conditions that cause knee joint pain (such as cancer, joint tumor)
• The subject who awaiting knee surgery
• The subject has an underlying disease that affects treatment during 1 year (such as cancer, liver disease, severe kidney disease, SLE)
• The subject has a history of vertebral fracture or leg bone fracture
• The subject has a nervous system disorder that affects balance (such as stroke or Parkinson's disease)
• The subject has an acute or chronic infectious disease
• The subject who had evidence of knee surgery
• The subject who has received intra-articular steroids or other substances within the last 6 months.
• The subject who has received symptomatic slow-acting drugs for osteoarthritis (SYSADOA) within the last 4 months
• The subject has a deformity of the knee joint.
• The subject has any other pathological conditions
• The subject has a communication problem
• The subject has claustrophobia

Sponsors & Collaborators

• Siriraj Hospital: lead

Study Sites (1)

Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Tatsanee Phermthai, PhD.

  Siriraj Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Invesitigator

Model Details: 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.

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 26, 2024
• Study Start: August 17, 2023
• Primary Completion: November 23, 2023
• Study Completion: March 1, 2025
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

TH (1)