Knee OsteoarthritisPhase 1NCT06386679
Amniotic Fluid Mesenchymal Stem Cells Developed for Chondrogenic Treatment (AFCC) Injection in Elderly Knee Osteoarthritis Patients
A Phase 1 study testing allogenic amniotic fluid mesenchymal stem cell in people with Knee Osteoarthritis, run by Siriraj Hospital at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- allogenic amniotic fluid mesenchymal stem cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteThailand
- Study dates
- 17 Aug 2023to Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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
- The subject who had surgery to insert a cardiac pacemaker
- The subject who had surgery to insert an aneurysm clip
- The subject who had surgery to insert a cochlear implant
- The subject has any internal metallic objects (such as metal plates, surgical clips, bullets)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- allogenic amniotic fluid mesenchymal stem cell
- Keywords
- Amniotic fluid mesenchymal stem cells, Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| AFCC injection | Experimental | Not described Receives: Biological: allogenic amniotic fluid mesenchymal stem cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Day 0 to 7, 14, 30, Month 2 to 12
Secondary outcomes (3)
Pain score
Change in pain in the affected knee joint in response to treatments using the Visual Analog Score (VAS)
Measured: 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
Measured: 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)
Measured: Screening (Month -3), Day 0, Month 3, and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start17 Aug 2023
- Primary completion23 Nov 2023
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tatsanee Phermthai, PhD., Siriraj Hospital
- Investigators
- Tatsanee Phermthai, PhD., Study director, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386679
- Sponsor's protocol ID
- R016634005
- Status last verified
- Apr 2024
- First submitted
- 29 Mar 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study: Safety and Efficacy of Allogenic Mesenchymal Stem Cell Type AFCC for Treating in Elderly Knee Osteoarthritis Patients
- ClinicalTrials.gov ID
- NCT06386679
- Acronym / sponsor ID
- R016634005
- Conditions
- Knee Osteoarthritis
- Keywords
- Amniotic fluid mesenchymal stem cells, Knee Osteoarthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 23 Nov 2023 (actual)
- Study completion
- Mar 2025 (estimated)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| AFCC injection | Experimental | Biological: allogenic amniotic fluid mesenchymal stem cell |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| allogenic amniotic fluid mesenchymal stem cellIntra-articular AFCC injection will be given for single knee for each patient in single dose, 20 million of AFCC in each dose | Biological | AFCC injection |
Primary outcome
Incidence of abnormal physical examination
Time frame: Month -3, Day 0, Month 3, 6 and 12
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.
Incidence of abnormal vital sign
Time frame: Month -3, Day 0, Month 3, 6 and 12
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.
Incidence of abnormal laboratory test results
Time frame: Day 0, Month 3, 6 and 12
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.
Incidence of abnormal ECG parameters
Time frame: Day 0, Month 3, 6 and 12
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
The type of Adverse event (AE), numbers of AE and proportion of patients with AE.
Time frame: Day 0 to 7, 14, 30, Month 2 to 12
AE will be monitored and recorded by the investigator throughout the study.
3 secondary outcomes
Pain score
Time frame: Screening (Month -3), Day 0, Month 3, 6, and 12
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Screening (Month -3), Day 0, Month 3, 6, and 12
Degree of cartilage change
Time frame: Screening (Month -3), Day 0, Month 3, and Month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tatsanee Phermthai, PhD. study director
Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing allogenic amniotic fluid mesenchymal stem cell in people with Knee Osteoarthritis, run by Siriraj Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of abnormal physical examination (time frame: Month -3, Day 0, Month 3, 6 and 12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.