KCT0006627Completed未知
Phase 1 Clinical Trial to Evaluate the Safety and Exploratory Efficacy of Osteoblast based Cell Therapy CF-M801 derived from Human Umbilical Cord in Patients with Osteonecrosis of the Femoral Head
CEFO0 sites9 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 9
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 19(Year) to 70(Year) (—)
- Sex
- All
Inclusion Criteria
- •1) Male and female between the ages of 19 and 70
- •2) diagnosed with at least one or more femoral head osteonecrosis
- •3) Association Research Circulation Osseous(ARCO) Classification criteria for osteonecrosis of the femoral head: ARCO phase I and phase II.
- •4) Those who have been treated for 3 months with conventional conservative treatment methods, but cannot expect improvement or alleviation of symptoms
- •5) Those who voluntarily consented in writing to this clinical trial
Exclusion Criteria
- •1)A person whose femoral bone necrosis is progressing rapidly
- •2)Screening tests show abnormal levels (AST or ALT levels are 2.5 times higher than the normal upper limit of clinical testing institutions)
- •3)Skeletal malignancy or bone metastasis in the femur head and femur
- •4)Previous history of malignancy (however, if it does not recur within 5 years of completion of treatment, can participate)
- •5) Inflammatory arthritis in the femur head
- •6) Nonspherical dysplasia with an angle of Lateral Center-Edge of less than 20 degrees.
- •7)Traumatic femoral bone necrosis
- •8) Systemic or local infectious diseases requiring systemic antibiotic treatment
- •9) Infectious diseases such as hepatitis and HIV
- •10) A person who need continuous, systemic, high-capacity corticosteroid therapy (Frednisone 7.5 mg/day or more) or immunosuppressants within six months after core decompression
- •11) A person with a history of administration of stem cell therapy before screening
- •12) Alcoholism and overconsumption
- •13) A person who has already undergone core decompression or other treatments and procedures that may affect femur head
- •14) BMI =40 kg/m2 at screening visit
- •15) Potential pregnant woman who does not agree to contraception during clinical trials.
- •16) Pregnant womon
Investigators
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