KCT0006627
Completed
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 enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Sponsor
- CEFO
- Enrollment
- 9
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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