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Safety and efficacy of cell active factor in the treatment of knee osteoarthritis

Safety and efficacy of cell active factor in the treatment of knee osteoarthritis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800018158
Enrollment
Unknown
Registered
2018-09-01
Start date
2018-10-01
Completion date
Unknown
Last updated
2018-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee osteoarthritis

Interventions

Group A (control group):Injection of 2ml hyaluronic acid
Group B (experimental group):2 ml of cell active factor was injected

Sponsors

The first people's Hospital of Hefei
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18 - 65 years old; 2) Gender: no limit; 3) History of primary osteoarthritis of the knee characterized by knee pain; or visual analog score of joint pain (VAS) = 2.5, or MRI diagnosed as osteoarthritis, or based on Kellgren-Lawrence grading criteria, knee joint X-ray diagnosis was grade II-IV osteoarthritis; 4) Area of cartilage defect: 2-6 cm2; serum collagen II is higher than normal; 5) Patients have difficulty in at least one of the following activities due to knee pain: lifting and carrying groceries, walking 400 meters, entering or exiting the chair or going up and down the stairs; or chronic knee pain with mechanical characteristics; or caused by degenerative cartilage Joint swelling, pain, stiffness, gait changes and history of exercise loss; 6) The patient has been given medication for the past three months. The drug includes anti-inflammatory drugs or analgesics; or the patient does not respond to the existing analgesic drugs and needs interventional therapy; 7) The patient is in good health except for knee symptoms; 8) The subject or his or her guardian is required to sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Study the history of joints or major trauma, fractures; 2) Study signs of inflammation at or around the joints, including: redness, fever, and a large amount of bulging fluid in the knee joint, accompanied by loss of normal contours of the joint; 3) Knee X-ray examination has other pathological damage; 4) Patients with severe incapacity or disability, ACR function rating is IV, or can not walk without auxiliary equipment; 5) Congenital or acquired malformation leads to severe knee deformity (inversion 30 (obesity class II); 8) The patient has coagulopathy, poorly controlled diabetes or other doctors believe it is a contraindication to interference with cartilage repair; 9) Patients have alcohol or drug abuse for nearly 6 months; 10) The patient has any potential or current medically-accepted mental illness (which may affect the assessment of the subject); 11) Uncontrolled bacterial, fungal or viral patients with severe systemic or local infection, including hepatitis A, hepatitis B, hepatitis C, HIV, syphilis positive patients; 12) Patients with severe cardiac dysfunction, such as left ventricular ejection rate < 50%; patients with right ventricular failure, arrhythmia and other dysfunction; 13) Uncontrolled high blood pressure or congestive heart failure, active angina requiring nitrate, myocardial infarction or arrhythmia or heart failure requiring active treatment in the past 6 months; 14) Patients with pulmonary hypertension; 15) Patients with diffuse alveolar hemorrhage and other progressive lung disease may need to maintain a blood oxygen level through a mask or other auxiliary machinery; hypoxemia, oxygen saturation < 90%; 16) Respiratory failure with restrictive or obstructive pulmonary disease or ventilator support; 17) In patients with severe liver dysfunction, alanine aminotransferase, total bilirubin is more than 3 times the normal maximum value; 18) Severe hepatic vein occlusive disease or sinus obstruction; 19) Severe renal insufficiency, creatinine is more than 2 times the normal maximum value; creatinine clearance is < 30 mL/min; 20) Pregnant women or patients planning to become pregnant, breast-feeding patients; 21) Patients who are participating in other clinical trials; 22) Severe allergies and patients known to be allergic to hyaluronic acid products; 23) The researchers believe that other reasons are not suitable for clinical trials.

Design outcomes

Primary

MeasureTime frame
Walking 20-meter pain visual analogue scale;

Countries

China

Contacts

Public ContactGao Bin

The First People's Hospital of Hefei

gaobin_3136@163.com+86 13905511671

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026