Clinical trial phase 1 of umbilical cord-derived osteoblast-based cell therapy for osteonecrosis of the femoral head

Not Applicable

Completed

• Conditions: Diseases of the musculoskeletal system and connective tissue

• Registration Number: KCT0006627
• Lead Sponsor: CEFO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-06-13
• Last Update Posted: 1 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety Test (Serious Adverse Event, Adverse Drug Reaction)

Secondary Outcome Measures

Name	Time	Method
X-ray & MRI, Visual analogue scale, Harrise Hip Scores, WOMAC scores