A Phase 1 interventional study of Animal early embryo extract in Knee Arthritis, Osteoarthritis, sponsored by Anhui HygeianCells BioMedical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Anhui HygeianCells BioMedical Co., Ltd. · Phase 1, Interventional, and Treatment
Among 74 studies in Osteoarthritis with a site in China — 23 open to participants now, 28 under way, 2 of them phase 3. Osteoarthritis · China.
Among the 74 studies in Osteoarthritis with a site in China, this one is the 45th largest by planned enrollment of the 53 interventional ones, is one of 15 that started in 2025, is one of 8 in phase 1, reaches primary completion later than 18 of the 27 other live ones, and was the 74th registered.
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's planned enrollment of 26 is below the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →23 of the 74 studies in Osteoarthritis with a site in China are open now, in 12 countries. Each count lists the studies.
Of the 287 Osteoarthritis studies recruiting now, 158 (55%) set no upper age limit and 72 (25%) stop at 75 or younger; 22 take children under 18; 30 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →74 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 15 started in 2025.
Median enrollment 139 across the 53 interventional studies, 120 across the 21 observational. Of the 35 that completed or were terminated, 11 (31%) have results posted.
29 of 74 have an industry lead sponsor. The 10 most frequent:
Anhui HygeianCells BioMedical Co., Ltd. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Anhui HygeianCells BioMedical Co., Ltd. has 1 study filed under Osteoarthritis — fewer than ten, so there is no comparison to draw.
7 of the studies in Osteoarthritis with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07301242Shanghai Geriatric Medical CenterPopulation Pharmacokinetics and Pharmacodynamics of Ciprofol | 2026-11 |
| NCT07347054Beijing Tiantan HospitalClinical Study of Myofascial Trigger Points(MTrPs) Injection in the Treatment of Shoulder Osteoarthritis(OA) | 2026-12-01 |
| NCT07544823The First Affiliated Hospital of Xinxiang Medical CollegeScreening for Biomarkers of Osteoarthritis | 2026-12-30 |
| NCT06082531Xijing HospitalEffect of Platelet-rich Plasma (PRP) Injection on Knee Osteoarthritis | 2026-12-31 |
| NCT07742696Peking University Third HospitalComparison of Postoperative Functional Outcomes Between Subvastus and Medial Parapatellar Approach in Total Knee Arthroplasty | 2027-02-15 |
Among the 74 studies in Osteoarthritis with a site in China, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Biological: Animal early embryo extract
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
Biological: Animal early embryo extract
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
Biological: Animal early embryo extract
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
Biological: Animal early embryo extract
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (screening) and 4 and 12 weeks after the last injection
Change from baseline in pain-free walking distance
Change in the maximum distance walked on a flat surface without knee pain, compared with screening.
Time frame: Baseline (screening) and 4 and 12 weeks after the last injection
Change from baseline in knee joint MRI findings
Change in cartilage morphology, cartilage thickness and subchondral bone marrow lesions on 3.0 T MRI of the index knee, assessed with a semi-quantitative scoring system, compared with the screening MRI.
Time frame: Baseline (screening) and 4 and 12 weeks after the last injection
Plan to share: 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.
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Mar 2027, 15 months after the start.
Of 35 industry-sponsored phase 1 interventional studies under Osteoarthritis, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 15 months is above that.
Counting every sponsor, half of 58 studies reached it within 20 months; a quarter within 9 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Anhui HygeianCells BioMedical Co., Ltd.