KneePhase 3ASAIKONCT06704893
Amniotic Suspension Allograft Injection for Knee Osteoarthritis
A Phase 3 study testing ASA injection 40 mg group, ASA injection 20 mg group and HA injection group in people with Knee and Osteoarthritis, run by Chang Gung Memorial Hospital at 2 sites in Taiwan.
Trial summary
There have been few clinical trials on ASA for the treatment of knee osteoarthritis, and there is currently no literature reporting the optimal treatment dosage. Non-surgical treatment options include braces, weight loss, lifestyle changes, oral pain relievers, and intra-articular injections. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee, Osteoarthritis
- What is being tested?
- ASA injection 40 mg group, ASA injection 20 mg group and HA injection group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 2 sitesTaiwan
- Study dates
- 21 Oct 2024to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years.
- Body mass index (BMI) less than 40 kg/m².
- Symptomatic knee osteoarthritis with X-ray evidence graded 2 or 3 on the Kellgren-Lawrence (KL) grading scale.
- Numerical Rating Scale (NRS) score (scale 1 to 10) for pain greater than 4 over the past 7 days.
- Able to walk independently or with the aid of a cane.
Who cannot join
- Pregnant women or women planning pregnancy.
- Regular use of anticoagulants.
- Use of pain medications (except acetaminophen) within 15 days prior to injection.
- History of substance abuse.
- Patients who take additional knee symptom-relief medications during the study must report it to the research team; failure to comply will result in exclusion.
- Corticosteroid or visco-supplementation injection into the affected knee within 3 months prior to enrollment.
- Knee surgery on the affected side within 12 months before enrollment, or surgery on the contralateral knee within 6 months before enrollment.
- 9. History of organ or hematopoietic stem cell transplant. 11. Current use of immunosuppressive agents. 12. Diagnosis of cancer within the past 5 years (except for treated basal cell carcinoma).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, Taiwan, 833
Po-Cheng Chen, MD, 88677317123, b9302081@cgmh.org.tw
- Recruiting
Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833
Po-Cheng Chen, MD, MPH, 88677317123 ext. 6286, b9302081@cgmh.org.tw
Po-Cheng Chen, MD, MPH
About this study
Official title: The Efficacy of Amniotic Suspension Allograft Injection in the Treatment of Knee Osteoarthritis: a Randomized Double-blind Controlled Trial
There have been few clinical trials on ASA for the treatment of knee osteoarthritis, and there is currently no literature reporting the optimal treatment dosage. Non-surgical treatment options include braces, weight loss, lifestyle changes, oral pain relievers, and intra-articular injections. Recently, placental-derived tissues have gradually been applied in the treatment of knee osteoarthritis. These tissues were initially used primarily for burns, ulcers, and wounds that are difficult to heal, but have now begun to be utilized in the orthopedic field. They have been proven to contain various anti-inflammatory cytokines and growth factors, which can reduce inflammation associated with arthritis. Reducing inflammation not only alleviates the pain of knee osteoarthritis but also improves patients' quality of life. The purpose of this study is to compare the therapeutic effects of amniotic suspension allograft (ASA), hyaluronic acid (HA), and saline on knee osteoarthritis and to examine whether there is a dose-response relationship with ASA injections.
Read the detailed description
According to statistics from the Ministry of Health and Welfare, the prevalence of knee osteoarthritis in Taiwan is approximately 15%. The main causes of the disease include overuse of joint cartilage and abnormal synovial fluid secretion, which impair joint mobility and cause symptoms like pain, swelling, and warmth. In severe cases, bone spurs and joint deformities can develop, further limiting mobility. Non-surgical treatment options for knee osteoarthritis currently include the use of braces, weight loss, lifestyle changes, oral pain relievers, and intra-articular injections, with only a small number of patients requiring surgery due to severe joint cartilage wear. In terms of injection treatments, given the limited efficacy of traditional corticosteroid and HA injections for knee osteoarthritis, an increasing number of physicians are using platelet-rich plasma (PRP) injections. Numerous clinical trials have supported this treatment option. However, the effectiveness of PRP treatment is partly dependent on the quality of the patient's blood. If the patient has poor blood quality (e.g., due to old age, multiple chronic diseases, autoimmune disorders, or use of anticoagulants), the efficacy of PRP injections will be significantly reduced.
Recently, a highly promising treatment option-placental-derived tissues-has begun to be used for knee osteoarthritis. Historically, placental-derived tissues have been applied to burns, ulcers, and other difficult-to-heal wounds such as corneal ulcers. More recently, these tissues have been applied in the orthopedic field. These products come in several formulations, some containing pulverized tissues (amniotic membrane, chorion, or both), cells from amniotic fluid, amniotic fluid itself, or a combination of these components. Placental tissues have been shown to contain a variety of anti-inflammatory cytokines, growth factors, and inhibitors, which are believed to reduce the inflammatory response associated with arthritis. Reducing this inflammation can not only alleviate the pain of knee osteoarthritis but also improve the quality of life for patients.
- Conditions
- Knee, Osteoarthritis
- Being tested
- ASA injection 40 mg group, ASA injection 20 mg group, HA injection group, Normal saline injection group
- Keywords
- double-blind randomized controlled trial, amniotic suspension allograft injection, knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASA injection 40 mg groupDrug
Participants will receive intra-articular knee injections under ultrasound guidance with AMNIOGEN® 40mg (HCT Regenerative, New Taipei, Taiwan) diluted in 3.0 mL of sterile normal saline.
ASA injection 20 mg groupDrug
Participants will receive intra-articular knee injections under ultrasound guidance with AMNIOGEN® 20mg (HCT Regenerative, New Taipei, Taiwan) diluted in 3.0 mL of sterile normal saline.
HA injection groupDrug
Participants will receive intra-articular knee injections under ultrasound guidance with 3 ml of HyLink (SEIKAGAKU CORPORATION, Tokyo, Japan).
Normal saline injection groupDrug
Participants will receive intra-articular knee injections under ultrasound guidance with 3 ml of sterile normal saline.
| Study group | Role | What they receive |
|---|---|---|
| ASA injection 40 mg group | Experimental | AMNIOGEN® 40mg (HCT Regenerative, New Taipei, Taiwan) was diluted in 3.0 mL of sterile normal saline. Receives: Drug: ASA injection 40 mg group |
| ASA injection 20 mg group | Experimental | AMNIOGEN® 20mg (HCT Regenerative, New Taipei, Taiwan) was diluted in 3.0 mL of sterile normal saline. Receives: Drug: ASA injection 20 mg group |
| HA injection group | Active comparator | 3 ml of HyLink (SEIKAGAKU CORPORATION, Tokyo, Japan) Receives: Drug: HA injection group |
| Normal saline injection group | Placebo comparator | 3 ml of sterile normal saline Receives: Drug: Normal saline injection group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
This scale assesses overall pain severity, with scores ranging from 0 (no pain) to 10 (severe pain). Measurements will be taken before treatment and at 1, 3, 6, and 12 months after treatment.
Measured: From enrollment to the end of study at 12 months
Knee Injury and Osteoarthritis Outcome Score (KOOS)
This questionnaire measures knee injury and osteoarthritis impact across five domains: pain, symptoms, activities of daily living (ADL), sport and recreation function, and quality of life. Measurements will be collected at baseline and at 1, 3, 6, and 12 months post-treatment. The resulting scores are transformed to a scale from 0 (extreme knee problems) to 100 (no knee problems).
Measured: From enrollment to the end of study at 12 months
The World Health Organization Quality of Life Brief Version (WHOQOL-BREF)
This quality-of-life assessment, developed by the World Health Organization, evaluates four domains: physical health, psychological well-being, social relationships, and environment. It will be administered before treatment and at 1, 3, 6, and 12 months post-treatment. The score of each domain ranges from 0 (worst outcome) to 100 (best outcome). The total score is the summation of each domain score.
Measured: From enrollment to the end of study at 12 months
Secondary outcomes (7)
Number of participants with abnormal Complete Blood Count (CBC)
Each participant will undergo blood tests for Complete Blood Count (CBC) before treatment, and at 1 month, 3 months, 6 months, and 12 months after treatment. Complete Blood Count (CBC) includes
- WBC in 1000/μL
- RBC in million/μL
- Hemoglobin in g/dL
- Hematocrit in %
- MCV in fL
- MCH in pg/cell
- MCHC in g/dL
- RDW in %
- RDW-SD in fL
- Platelet in 1000/μL
- PDW in fL
- MPV in fL All blood samples will be analyzed at the laboratory of Chang Gung Memorial Hospital. The investigators will count the number of participants with abnormal CBC.
Measured: From enrollment to the end of study at 12 months
C-reactive protein (CRP)
Each participant will undergo blood test for C-reactive protein (CRP in mg/L) before treatment, and at 1 month, 3 months, 6 months, and 12 months after treatment. All blood samples will be analyzed at the laboratory of Chang Gung Memorial Hospital.
Measured: From enrollment to the end of study at 12 months
Erythrocyte Sedimentation Rate (ESR)
Each participant will undergo blood test for Erythrocyte Sedimentation Rate (ESR in mm/hr) before treatment, and at 1 month, 3 months, 6 months, and 12 months after treatment. All blood samples will be analyzed at the laboratory of Chang Gung Memorial Hospital.
Measured: From enrollment to the end of study at 12 months
Cytokine IL-6
Each participant will undergo blood test for cytokine IL-6 in pg/mL before treatment, and at 1 month, 3 months, 6 months, and 12 months after treatment. All blood samples will be analyzed at the laboratory of Chang Gung Memorial Hospital.
Measured: From enrollment to the end of study at 12 months
Knee Ultrasound Imaging
Each participant will undergo ultrasound evaluation before treatment, and at 1 month, 3 months, 6 months, and 12 months after treatment. The evaluation will mainly assess the volume of effusion, the degree of damage to the medial and lateral femoral trochlear cartilage17 (grade 0: normal; grade 1: slightly blurred cartilage edges or increased echogenicity of the cartilage; grade 2A: partial thinning of the cartilage, thinning <50% of the original cartilage thickness; grade 2B: partial thinning of the cartilage, thinning >50% of the original cartilage thickness; grade 3: complete loss of cartilage thickness), and whether there is meniscus extrusion in the medial or lateral meniscus.
Measured: From enrollment to the end of study at 12 months
Knee X-ray
Each participant will undergo knee X-rays (AP view, lateral view, merchant view) at baseline and 12 months post-treatment.
Measured: From enrollment to the end of study at 12 months
Cartilage Oligomeric Matrix Protein (COMP)
Each participant will undergo blood test for Cartilage Oligomeric Matrix Protein (COMP in IU) before treatment, and at 1 month, 3 months, 6 months, and 12 months after treatment. All blood samples will be analyzed at the laboratory of Chang Gung Memorial Hospital.
Measured: From enrollment to the end of study at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start21 Oct 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KneeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Po-Cheng Chen, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704893
- Sponsor's protocol ID
- 202401278A3
- Acronym
- ASAIKO
- Status last verified
- Jan 2026
- First submitted
- 26 Oct 2024
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Secondary analysis might be performed after the primary study, so IPD will not be shared immediately after finishing the study
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Amniotic Suspension Allograft Injection in the Treatment of Knee Osteoarthritis: a Randomized Double-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT06704893
- Acronym / sponsor ID
- ASAIKO / 202401278A3
- Conditions
- Knee, Osteoarthritis
- Keywords
- double-blind randomized controlled trial, amniotic suspension allograft injection, knee osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Nov 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.
There have been few clinical trials on ASA for the treatment of knee osteoarthritis, and there is currently no literature reporting the optimal treatment dosage. Non-surgical treatment options include braces, weight loss, lifestyle changes, oral pain relievers, and intra-articular injections. Recently, placental-derived tissues have gradually been applied in the treatment of knee osteoarthritis. These tissues were initially used primarily for burns, ulcers, and wounds that are difficult to heal, but have now begun to be utilized in the orthopedic field. They have been proven to contain various anti-inflammatory cytokines and growth factors, which can reduce inflammation associated with arthritis. Reducing inflammation not only alleviates the pain of knee osteoarthritis but also improves patients' quality of life. The purpose of this study is to compare the therapeutic effects of amniotic suspension allograft (ASA), hyaluronic acid (HA), and saline on knee osteoarthritis and to examine whether there is a dose-response relationship with ASA injections.
Detailed description
According to statistics from the Ministry of Health and Welfare, the prevalence of knee osteoarthritis in Taiwan is approximately 15%. The main causes of the disease include overuse of joint cartilage and abnormal synovial fluid secretion, which impair joint mobility and cause symptoms like pain, swelling, and warmth. In severe cases, bone spurs and joint deformities can develop, further limiting mobility. Non-surgical treatment options for knee osteoarthritis currently include the use of braces, weight loss, lifestyle changes, oral pain relievers, and intra-articular injections, with only a small number of patients requiring surgery due to severe joint cartilage wear. In terms of injection treatments, given the limited efficacy of traditional corticosteroid and HA injections for knee osteoarthritis, an increasing number of physicians are using platelet-rich plasma (PRP) injections. Numerous clinical trials have supported this treatment option. However, the effectiveness of PRP treatment is partly dependent on the quality of the patient's blood. If the patient has poor blood quality (e.g., due to old age, multiple chronic diseases, autoimmune disorders, or use of anticoagulants), the efficacy of PRP injections will be significantly reduced.
Recently, a highly promising treatment option-placental-derived tissues-has begun to be used for knee osteoarthritis. Historically, placental-derived tissues have been applied to burns, ulcers, and other difficult-to-heal wounds such as corneal ulcers. More recently, these tissues have been applied in the orthopedic field. These products come in several formulations, some containing pulverized tissues (amniotic membrane, chorion, or both), cells from amniotic fluid, amniotic fluid itself, or a combination of these components. Placental tissues have been shown to contain a variety of anti-inflammatory cytokines, growth factors, and inhibitors, which are believed to reduce the inflammatory response associated with arthritis. Reducing this inflammation can not only alleviate the pain of knee osteoarthritis but also improve the quality of life for patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ASA injection 40 mg group | Experimental | Drug: ASA injection 40 mg groupAMNIOGEN® 40mg (HCT Regenerative, New Taipei, Taiwan) was diluted in 3.0 mL of sterile normal saline. |
| ASA injection 20 mg group | Experimental | Drug: ASA injection 20 mg groupAMNIOGEN® 20mg (HCT Regenerative, New Taipei, Taiwan) was diluted in 3.0 mL of sterile normal saline. |
| HA injection group | Active comparator | Drug: HA injection group3 ml of HyLink (SEIKAGAKU CORPORATION, Tokyo, Japan) |
| Normal saline injection group | Placebo comparator | Drug: Normal saline injection group3 ml of sterile normal saline |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 80 years.
- Body mass index (BMI) less than 40 kg/m².
- Symptomatic knee osteoarthritis with X-ray evidence graded 2 or 3 on the Kellgren-Lawrence (KL) grading scale.
- Numerical Rating Scale (NRS) score (scale 1 to 10) for pain greater than 4 over the past 7 days.
- Able to walk independently or with the aid of a cane.
Key exclusion criteria (8 listed)
- Pregnant women or women planning pregnancy.
- Regular use of anticoagulants.
- Use of pain medications (except acetaminophen) within 15 days prior to injection.
- History of substance abuse.
- Patients who take additional knee symptom-relief medications during the study must report it to the research team; failure to comply will result in exclusion.
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 |
|---|---|---|
| ASA injection 40 mg groupParticipants will receive intra-articular knee injections under ultrasound guidance with AMNIOGEN® 40mg (HCT Regenerative, New Taipei, Taiwan) diluted in 3.0 mL of sterile normal saline. | Drug | ASA injection 40 mg group |
| ASA injection 20 mg groupParticipants will receive intra-articular knee injections under ultrasound guidance with AMNIOGEN® 20mg (HCT Regenerative, New Taipei, Taiwan) diluted in 3.0 mL of sterile normal saline. | Drug | ASA injection 20 mg group |
| HA injection groupParticipants will receive intra-articular knee injections under ultrasound guidance with 3 ml of HyLink (SEIKAGAKU CORPORATION, Tokyo, Japan). | Drug | HA injection group |
| Normal saline injection groupParticipants will receive intra-articular knee injections under ultrasound guidance with 3 ml of sterile normal saline. | Drug | Normal saline injection group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: From enrollment to the end of study at 12 months
This scale assesses overall pain severity, with scores ranging from 0 (no pain) to 10 (severe pain). Measurements will be taken before treatment and at 1, 3, 6, and 12 months after treatment.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: From enrollment to the end of study at 12 months
This questionnaire measures knee injury and osteoarthritis impact across five domains: pain, symptoms, activities of daily living (ADL), sport and recreation function, and quality of life. Measurements will be collected at baseline and at 1, 3, 6, and 12 months post-treatment. The resulting scores are transformed to a scale from 0 (extreme knee problems) to 100 (no knee problems).
The World Health Organization Quality of Life Brief Version (WHOQOL-BREF)
Time frame: From enrollment to the end of study at 12 months
This quality-of-life assessment, developed by the World Health Organization, evaluates four domains: physical health, psychological well-being, social relationships, and environment. It will be administered before treatment and at 1, 3, 6, and 12 months post-treatment. The score of each domain ranges from 0 (worst outcome) to 100 (best outcome). The total score is the summation of each domain score.
7 secondary outcomes
Number of participants with abnormal Complete Blood Count (CBC)
Time frame: From enrollment to the end of study at 12 months
C-reactive protein (CRP)
Time frame: From enrollment to the end of study at 12 months
Erythrocyte Sedimentation Rate (ESR)
Time frame: From enrollment to the end of study at 12 months
Cytokine IL-6
Time frame: From enrollment to the end of study at 12 months
Knee Ultrasound Imaging
Time frame: From enrollment to the end of study at 12 months
Knee X-ray
Time frame: From enrollment to the end of study at 12 months
Cartilage Oligomeric Matrix Protein (COMP)
Time frame: From enrollment to the end of study at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: Undecided. Secondary analysis might be performed after the primary study, so IPD will not be shared immediately after finishing the study
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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.
Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ASA injection 40 mg group, ASA injection 20 mg group and HA injection group in people with Knee and Osteoarthritis, run by Chang Gung Memorial Hospital at 2 sites in Taiwan.
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 8 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: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: From enrollment to the end of study at 12 months). The study lists 3 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 Jan 2026.