A Single-Center Phase 1 Study of ceAF for Knee Osteoarthritis (KOA)
A legfontosabb adatok
- Ki végzi
- Anhui HygeianCells BioMedical Co., Ltd.
- Hol
- Huangshan City (Kína)A helyszín megnézése
- Azonosító
- Állapot
- Toboroz
- Fázis
- 1. fázis
- Résztvevők
- 26 fő, tervezett
- Kezdés
- 2025. dec. 10.
- Várható befejezés
- 2027. nov. 30.
- A vizsgálat típusa
- Beavatkozással járó, 4 csoport
- A vizsgált kezelések
- Animal early embryo extract
- A regiszteradat frissítve
- 2026. október 28.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
The trial is looking for adults with knee osteoarthritis (wear-and-tear arthritis) in both knees and moderate knee pain. They get injections of an animal early embryo extract (ceAF) into the knee.
- Életkor
- 18 to 70 years
- Nem
- Male or female
- A betegség stádiuma
- Knee osteoarthritis for 6 months or more and less than 10 years. Kellgren-Lawrence grade III or IV on X-ray of both knees. Knee pain score of 4 or more and less than 8 (out of 10) in both knees. Must be able to walk without crutches, a walker or a wheelchair.
- Korábbi kezelés
- No knee injection for osteoarthritis (such as hyaluronic acid, corticosteroids, platelet-rich plasma or bone morphogenetic protein) within 6 months. No knee surgery within 6 months. No glucosamine or chondroitin sulfate within 4 weeks. Pain medicine must be stopped at least 3 days before the pain check.
A részvétel fő kizáró okai
- Allergy to one or more drugs, to eggs, or to two or more foods
- Body mass index greater than 30 kg/m2
- Past cancer, or a bleeding (clotting) disorder
- Other joint diseases such as rheumatic arthritis, gout-like crystal disease or joint infection
- Serious uncontrolled heart, brain, liver, kidney, lung or hormone disease
A regiszter feltételei, szó szerint
Mind a 18 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- 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
- Knee arthroscopic surgery, or other open surgery involving the knee, within 6 months before the start of the study
- Glucosamine and/or chondroitin sulfate treatment within 4 weeks before the start of the study
- Allergy to one or more drugs, to eggs, or to two or more foods
- Uncontrolled or difficult-to-control cardiovascular, cerebrovascular, hepatic, renal, pulmonary, endocrine or other systemic disease
- History of malignant tumour
- Relatively severe lower limb disease that may interfere with knee assessment, such as fibromyalgia, significant low back pain or lumbar disc herniation
- Coagulation disorder
- 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
- Body mass index greater than 30 kg/m2
Nézd meg, megfelelhetsz-e
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 18 és 70 év között vagy?
Helyszínek itt: Kína
- Huangshan People's HospitalHuangshan City, KínaContact: XUN WU, MDRésztvevőt keres
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A teljes eredeti leírásKevesebb
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.
A vizsgálat 4 csoportja
- Arm 1: Single-dose animal early embryo extract 1.0 mLA vizsgált kezelés
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
Kezelés: Animal early embryo extract
- Arm 2: Single-dose animal early embryo extract 1.5 mLA vizsgált kezelés
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
Kezelés: Animal early embryo extract
- Arm 3: Single-dose animal early embryo extract 2.0 mLA vizsgált kezelés
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
Kezelés: Animal early embryo extract
- Arm 4: Multiple-dose animal early embryo extract (dose selected from Part 1)A vizsgált kezelés
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
Kezelés: Animal early embryo extract
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- A Research Collaboration Project to Evaluate the Efficacy and Safety of Animal Early Embryo Extract ceAF in the Treatment of Patients With Knee Osteoarthritis
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 14.
- Illeszkedési kérdések
- Forrás: NCT07902128: ki vehet részt
- A regiszteradat frissítve
- 2026. október 28.