Knee Arthritis, OsteoarthritisPhase 1KOANCT07902128
A Single-Center Phase 1 Study of ceAF for Knee Osteoarthritis (KOA)
A Phase 1 study testing Animal early embryo extract in people with Knee Arthritis, Osteoarthritis, run by Anhui HygeianCells BioMedical Co., Ltd. at 1 site in China.
Trial summary
Approximately 25 participants aged 18-70 years, with knee pain rated 4-7 on a 10-point visual analogue scale (VAS) and a disease duration of 6 months to 10 years, will be enrolled. The study has two parts. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Knee Arthritis, Osteoarthritis
- What is being tested?
- Animal early embryo extract
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2025to 30 Nov 2027
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant (or legal representative) voluntarily agrees to participate and provides written informed consent.
- Age 18-70 years, inclusive; male or female.
- Definite diagnosis of knee osteoarthritis according to the 2010 diagnostic criteria of the Rheumatology Branch of the Chinese Medical Association.
- Duration of knee osteoarthritis of 6 months or more and less than 10 years.
- Knee pain VAS score of 4 or more and less than 8 in both knees, assessed at least 3 days after discontinuation of all analgesic medication.
- Kellgren-Lawrence grade III or IV on X-ray of both knees.
- Able to walk independently; participants requiring crutches, a walker or a wheelchair are not eligible.
Who cannot join
- Allergy to one or more drugs, to eggs, or to two or more foods.
- Body mass index greater than 30 kg/m2.
- Uncontrolled or difficult-to-control cardiovascular, cerebrovascular, hepatic, renal, pulmonary, endocrine or other systemic disease.
- History of malignant tumour.
- Concomitant systemic or rheumatic arthritis chondropathy, chondrocalcinosis, haemochromatosis, infectious arthropathy, avascular necrosis of the femoral head, Paget's disease, haemophilic arthropathy, Charcot arthropathy, pigmented villonodular synovitis or synovial chondromatosis.
- Relatively severe systemic infection, or local knee joint infection (including skin and intra-articular infection), within 3 months before the start of the study.
Show all 11Show fewer
- Relatively severe lower limb disease that may interfere with knee assessment, such as fibromyalgia, significant low back pain or lumbar disc herniation.
- Coagulation disorder.
- Knee arthroscopic surgery, or other open surgery involving the knee, within 6 months before the start of the study.
- Intra-articular injection for knee osteoarthritis within 6 months before the start of the study, including but not limited to hyaluronic acid, corticosteroids, platelet-rich plasma and bone morphogenetic protein.
- Glucosamine and/or chondroitin sulfate treatment within 4 weeks before the start of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Huangshan People's Hospital
Huangshan City, Anhui, 245000
XUN WU, MD, +86 13805596729, 29481331@qq.com
XUN WU, MD
About this study
Official title: A Research Collaboration Project to Evaluate the Efficacy and Safety of Animal Early Embryo Extract ceAF in the Treatment of Patients With Knee Osteoarthritis
Approximately 25 participants aged 18-70 years, with knee pain rated 4-7 on a 10-point visual analogue scale (VAS) and a disease duration of 6 months to 10 years, will be enrolled. The study has two parts. In Part 1, participants receive a single intra-articular injection of 1.0 mL, 1.5 mL or 2.0 mL of study product (3-5 participants per dose level, given in ascending order). In Part 2, the dose with the most favourable balance of efficacy and safety in Part 1 is given weekly by intra-articular injection for 2-3 doses to an additional 6-10 participants.
Participants are followed for 12 weeks after the last injection. Safety is assessed through adverse events (graded by CTCAE v5.0), vital signs, physical examination, electrocardiogram, clinical laboratory tests (haematology, urinalysis, liver and kidney biochemistry, coagulation) and pregnancy testing. Efficacy is assessed by change from baseline in knee X-ray, knee MRI, the Knee injury and Osteoarthritis Outcome Score (KOOS), the WOMAC index, pain VAS and pain-free walking distance at 4 and 12 weeks after the last dose.
The study has no placebo or active comparator group. There is no plan to market the product on the basis of this study.
Read the detailed description
BACKGROUND. Knee osteoarthritis is a degenerative joint disease with a prevalence of symptomatic disease of about 8.1% in China, rising to 50% in people over 65 years and up to 80% in people over 75 years. Existing treatments control symptoms but do not repair cartilage. Animal early embryo extract (designated ceAF) is a cell-free preparation derived from early chick embryo amniotic fluid that contains composite growth-promoting factors and inflammatory factor inhibitors. Unlike direct use of embryonic stem cells, the product is cell-free, which avoids the tumorigenic and sourcing limitations of cell therapy while retaining biological activity. Preclinical work includes pharmacodynamic studies in mouse and porcine myocardial infarction models, a single-dose intra-articular toxicity study in SD rats, and 1-week repeat-dose intravenous toxicity studies in SD rats and cynomolgus monkeys, with no test-article-related toxic findings at the doses tested. An investigator-initiated study of intravenous animal early embryo extract in 6 participants (3 healthy adults, 3 with cardiac insufficiency) reported no adverse reactions during 7-30 days of follow-up. This is the first study of intra-articular administration in knee osteoarthritis.
DESIGN. Single-centre, open-label, dose-escalation study in two sequential parts. Part 1 (single administration): three dose levels of 1.0 mL, 1.5 mL and 2.0 mL, given as one intra-articular injection into the index knee, with 3-5 participants per level; dose escalation proceeds in ascending order after review of safety data from the preceding level. Part 2 (multiple administration): the dose selected from Part 1 is given once weekly for 2-3 doses, with the third dose given at the investigator's discretion according to clinical response; 6-10 participants are planned. Total enrolment is approximately 25 participants.
DOSE RATIONALE. The starting intra-articular dose of 1.0 mL was selected conservatively, based on doses used in clinical studies of similar cell-based products and on extrapolation from the no-observed-adverse-effect level in the 1-week repeat-dose intravenous toxicology studies in cynomolgus monkeys (1.5, 5 and 15 mL/kg/day). Intra-articular administration is expected to carry lower systemic exposure than intravenous administration.
ASSESSMENTS. Screening within 7 days before dosing includes demographics, medical history, vital signs, physical examination, ECG, knee X-ray and MRI, haematology, urinalysis, liver and kidney biochemistry, coagulation, serological tests for HBV, HCV, HIV and syphilis, pregnancy testing, KOOS, WOMAC, pain VAS and pain-free walking distance. After dosing, ECG and laboratory tests are performed at 1 week after each injection; X-ray, MRI, KOOS, WOMAC, VAS and pain-free walking distance are repeated at 4 and 12 weeks after the last injection. Adverse events and concomitant medication use are recorded throughout.
ANALYSIS. The Full Analysis Set (all enrolled participants who received at least one dose) is used for efficacy and the Safety Set (same definition) for safety. Safety data are summarised descriptively by dose group, with adverse events coded using MedDRA and graded by CTCAE v5.0. Efficacy endpoints are summarised descriptively as change from baseline at each time point; no formal hypothesis testing is planned given the sample size.
- Conditions
- Knee Arthritis, Osteoarthritis
- Being tested
- Animal early embryo extract
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal early embryo extractBiological
A cell-free biological preparation manufactured by Anhui Hygeiancells Co., Ltd. from early chick embryo amniotic fluid, containing composite growth-promoting factors and inflammatory factor inhibitors. Supplied as a sterile injection, 2 mL per bag, stored below -60 °C, shelf life 60 months. Administered by local intra-articular injection into the knee.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Single-dose animal early embryo extract 1.0 mL | Experimental | Description: Participants receive one intra-articular injection of 1.0 mL animal early embryo extract into the index knee on Day 1.
Intervention: Animal early embryo extract - 1.0 mL, single intra-articular injection Receives: Biological: Animal early embryo extract |
| Arm 2: Single-dose animal early embryo extract 1.5 mL | Experimental | Description: Participants receive one intra-articular injection of 1.5 mL animal early embryo extract into the index knee on Day 1.
Intervention: Animal early embryo extract - 1.5 mL, single intra-articular injection Receives: Biological: Animal early embryo extract |
| Arm 3: Single-dose animal early embryo extract 2.0 mL | Experimental | Description: Participants receive one intra-articular injection of 2.0 mL animal early embryo extract into the index knee on Day 1.
Intervention: Animal early embryo extract - 2.0 mL, single intra-articular injection Receives: Biological: Animal early embryo extract |
| Arm 4: Multiple-dose animal early embryo extract (dose selected from Part 1) | Experimental | Description: Participants receive the dose selected from Part 1 (1.0, 1.5 or 2.0 mL) by intra-articular injection once weekly for 2-3 doses; the third dose is given at the investigator's discretion.
Intervention: Animal early embryo extract - selected dose, weekly intra-articular injection for 2-3 doses Receives: Biological: Animal early embryo extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety observation
Number and percentage of participants with any adverse event, treatment-related adverse event, serious adverse event and adverse event leading to discontinuation, graded by CTCAE v5.0; includes clinically significant changes in vital signs, ECG and laboratory parameters.
Measured: From informed consent signature through 12 weeks after the last injection
Change from baseline in knee joint X-ray findings
Change in Kellgren-Lawrence grade and medial joint space width on weight-bearing anteroposterior radiograph of the index knee, compared with the screening radiograph.
Measured: Baseline (screening) and 4 and 12 weeks after the last injection
Change from baseline in Knee injury and Osteoarthritis Outcome Score (KOOS)
Change in the five KOOS subscales (pain, symptoms, activities of daily living, sport and recreation, knee-related quality of life), each scored 0-100, where 100 indicates no problems.
Measured: Baseline (screening) and 4 and 12 weeks after the last injection
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Change in the WOMAC pain, stiffness and physical function subscales (visual analogue scale version), scale 0-96, higher scores mean worse outcome.
Measured: Baseline (screening) and 4 and 12 weeks after the last injection
Change from baseline in knee pain on a visual analogue scale (VAS)
Change in participant-rated knee pain on a 0-10 VAS (0 = no pain, 10 = worst imaginable pain), assessed at least 3 days after discontinuation of all analgesic medication.
Measured: Baseline (screening) and 4 and 12 weeks after the last injection
Secondary outcomes (1)
Change from baseline in pain-free walking distance
Change in the maximum distance walked on a flat surface without knee pain, compared with screening.
Measured: Baseline (screening) and 4 and 12 weeks after the last injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start10 Dec 2025
- Primary completionMar 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthritis, 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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui HygeianCells BioMedical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- JIN QIAN, PhD, Study chair, Anhui Hygeiancells Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902128
- Sponsor's protocol ID
- EE001-02-KOA
- Other IDs
- CY-OA-001
- Acronym
- KOA
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will not be shared. This is an investigator-initiated early-phase study with a small sample size, and the informed consent form does not include permission for data sharing. Summary results will be posted on ClinicalTrials.gov.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Research Collaboration Project to Evaluate the Efficacy and Safety of Animal Early Embryo Extract ceAF in the Treatment of Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07902128
- Acronym / sponsor ID
- KOA / EE001-02-KOA
- Conditions
- Knee Arthritis, Osteoarthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Anhui HygeianCells BioMedical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 28 Oct 2026 (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.
Approximately 25 participants aged 18-70 years, with knee pain rated 4-7 on a 10-point visual analogue scale (VAS) and a disease duration of 6 months to 10 years, will be enrolled. The study has two parts. In Part 1, participants receive a single intra-articular injection of 1.0 mL, 1.5 mL or 2.0 mL of study product (3-5 participants per dose level, given in ascending order). In Part 2, the dose with the most favourable balance of efficacy and safety in Part 1 is given weekly by intra-articular injection for 2-3 doses to an additional 6-10 participants.
Participants are followed for 12 weeks after the last injection. Safety is assessed through adverse events (graded by CTCAE v5.0), vital signs, physical examination, electrocardiogram, clinical laboratory tests (haematology, urinalysis, liver and kidney biochemistry, coagulation) and pregnancy testing. Efficacy is assessed by change from baseline in knee X-ray, knee MRI, the Knee injury and Osteoarthritis Outcome Score (KOOS), the WOMAC index, pain VAS and pain-free walking distance at 4 and 12 weeks after the last dose.
The study has no placebo or active comparator group. There is no plan to market the product on the basis of this study.
Detailed description
BACKGROUND. Knee osteoarthritis is a degenerative joint disease with a prevalence of symptomatic disease of about 8.1% in China, rising to 50% in people over 65 years and up to 80% in people over 75 years. Existing treatments control symptoms but do not repair cartilage. Animal early embryo extract (designated ceAF) is a cell-free preparation derived from early chick embryo amniotic fluid that contains composite growth-promoting factors and inflammatory factor inhibitors. Unlike direct use of embryonic stem cells, the product is cell-free, which avoids the tumorigenic and sourcing limitations of cell therapy while retaining biological activity. Preclinical work includes pharmacodynamic studies in mouse and porcine myocardial infarction models, a single-dose intra-articular toxicity study in SD rats, and 1-week repeat-dose intravenous toxicity studies in SD rats and cynomolgus monkeys, with no test-article-related toxic findings at the doses tested. An investigator-initiated study of intravenous animal early embryo extract in 6 participants (3 healthy adults, 3 with cardiac insufficiency) reported no adverse reactions during 7-30 days of follow-up. This is the first study of intra-articular administration in knee osteoarthritis.
DESIGN. Single-centre, open-label, dose-escalation study in two sequential parts. Part 1 (single administration): three dose levels of 1.0 mL, 1.5 mL and 2.0 mL, given as one intra-articular injection into the index knee, with 3-5 participants per level; dose escalation proceeds in ascending order after review of safety data from the preceding level. Part 2 (multiple administration): the dose selected from Part 1 is given once weekly for 2-3 doses, with the third dose given at the investigator's discretion according to clinical response; 6-10 participants are planned. Total enrolment is approximately 25 participants.
DOSE RATIONALE. The starting intra-articular dose of 1.0 mL was selected conservatively, based on doses used in clinical studies of similar cell-based products and on extrapolation from the no-observed-adverse-effect level in the 1-week repeat-dose intravenous toxicology studies in cynomolgus monkeys (1.5, 5 and 15 mL/kg/day). Intra-articular administration is expected to carry lower systemic exposure than intravenous administration.
ASSESSMENTS. Screening within 7 days before dosing includes demographics, medical history, vital signs, physical examination, ECG, knee X-ray and MRI, haematology, urinalysis, liver and kidney biochemistry, coagulation, serological tests for HBV, HCV, HIV and syphilis, pregnancy testing, KOOS, WOMAC, pain VAS and pain-free walking distance. After dosing, ECG and laboratory tests are performed at 1 week after each injection; X-ray, MRI, KOOS, WOMAC, VAS and pain-free walking distance are repeated at 4 and 12 weeks after the last injection. Adverse events and concomitant medication use are recorded throughout.
ANALYSIS. The Full Analysis Set (all enrolled participants who received at least one dose) is used for efficacy and the Safety Set (same definition) for safety. Safety data are summarised descriptively by dose group, with adverse events coded using MedDRA and graded by CTCAE v5.0. Efficacy endpoints are summarised descriptively as change from baseline at each time point; no formal hypothesis testing is planned given the sample size.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Single-dose animal early embryo extract 1.0 mL | Experimental | Biological: Animal early embryo extractDescription: Participants receive one intra-articular injection of 1.0 mL animal early embryo extract into the index knee on Day 1. Intervention: Animal early embryo extract - 1.0 mL, single intra-articular injection |
| Arm 2: Single-dose animal early embryo extract 1.5 mL | Experimental | Biological: Animal early embryo extractDescription: Participants receive one intra-articular injection of 1.5 mL animal early embryo extract into the index knee on Day 1. Intervention: Animal early embryo extract - 1.5 mL, single intra-articular injection |
| Arm 3: Single-dose animal early embryo extract 2.0 mL | Experimental | Biological: Animal early embryo extractDescription: Participants receive one intra-articular injection of 2.0 mL animal early embryo extract into the index knee on Day 1. Intervention: Animal early embryo extract - 2.0 mL, single intra-articular injection |
| Arm 4: Multiple-dose animal early embryo extract (dose selected from Part 1) | Experimental | Biological: Animal early embryo extractDescription: Participants receive the dose selected from Part 1 (1.0, 1.5 or 2.0 mL) by intra-articular injection once weekly for 2-3 doses; the third dose is given at the investigator's discretion. Intervention: Animal early embryo extract - selected dose, weekly intra-articular injection for 2-3 doses |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant (or legal representative) voluntarily agrees to participate and provides written informed consent.
- Age 18-70 years, inclusive; male or female.
- Definite diagnosis of knee osteoarthritis according to the 2010 diagnostic criteria of the Rheumatology Branch of the Chinese Medical Association.
- Duration of knee osteoarthritis of 6 months or more and less than 10 years.
- Knee pain VAS score of 4 or more and less than 8 in both knees, assessed at least 3 days after discontinuation of all analgesic medication.
Key exclusion criteria (11 listed)
- Allergy to one or more drugs, to eggs, or to two or more foods.
- Body mass index greater than 30 kg/m2.
- Uncontrolled or difficult-to-control cardiovascular, cerebrovascular, hepatic, renal, pulmonary, endocrine or other systemic disease.
- History of malignant tumour.
- Concomitant systemic or rheumatic arthritis chondropathy, chondrocalcinosis, haemochromatosis, infectious arthropathy, avascular necrosis of the femoral head, Paget's disease, haemophilic arthropathy, Charcot arthropathy, pigmented villonodular synovitis or synovial chondromatosis.
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 |
|---|---|---|
| Animal early embryo extractA cell-free biological preparation manufactured by Anhui Hygeiancells Co., Ltd. from early chick embryo amniotic fluid, containing composite growth-promoting factors and inflammatory factor inhibitors. Supplied as a sterile injection, 2 mL per bag, stored below -60 °C, shelf life 60 months. Administered by local intra-articular injection into the knee. | Biological | Arm 1: Single-dose animal early embryo extract 1.0 mL, Arm 2: Single-dose animal early embryo extract 1.5 mL, Arm 3: Single-dose animal early embryo extract 2.0 mL, Arm 4: Multiple-dose animal early embryo extract (dose selected from Part 1) |
Primary outcome
Safety observation
Time frame: From informed consent signature through 12 weeks after the last injection
Number and percentage of participants with any adverse event, treatment-related adverse event, serious adverse event and adverse event leading to discontinuation, graded by CTCAE v5.0; includes clinically significant changes in vital signs, ECG and laboratory parameters.
Change from baseline in knee joint X-ray findings
Time frame: Baseline (screening) and 4 and 12 weeks after the last injection
Change in Kellgren-Lawrence grade and medial joint space width on weight-bearing anteroposterior radiograph of the index knee, compared with the screening radiograph.
Change from baseline in Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline (screening) and 4 and 12 weeks after the last injection
Change in the five KOOS subscales (pain, symptoms, activities of daily living, sport and recreation, knee-related quality of life), each scored 0-100, where 100 indicates no problems.
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Baseline (screening) and 4 and 12 weeks after the last injection
Change in the WOMAC pain, stiffness and physical function subscales (visual analogue scale version), scale 0-96, higher scores mean worse outcome.
Change from baseline in knee pain on a visual analogue scale (VAS)
Time frame: Baseline (screening) and 4 and 12 weeks after the last injection
Change in participant-rated knee pain on a 0-10 VAS (0 = no pain, 10 = worst imaginable pain), assessed at least 3 days after discontinuation of all analgesic medication.
1 secondary outcome
Change from baseline in pain-free walking distance
Time frame: Baseline (screening) and 4 and 12 weeks after the last injection
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 28 Oct 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data will not be shared. This is an investigator-initiated early-phase study with a small sample size, and the informed consent form does not include permission for data sharing. Summary results will be posted on ClinicalTrials.gov.
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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.
JIN QIAN, PhD study chair
Anhui Hygeiancells Co., Ltd.
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 Animal early embryo extract in people with Knee Arthritis, Osteoarthritis, run by Anhui HygeianCells BioMedical Co., Ltd. at 1 site in China.
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 7 inclusion and 11 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 28 Oct 2026. 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 China. 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?
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?
Contact WENLIAN XU, PhD (+86 13811619762, xuwenlian@hygeiancells.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety observation (time frame: From informed consent signature through 12 weeks after the last injection). 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 28 Oct 2026.