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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0006627

Enrollment

Registered

2021-09-30

Start date

2022-01-17

Completion date

Unknown

Last updated

2023-08-01

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

Conditions

None listed

Interventions

Biological/Vaccine, Non-Stem Cell : CF-M801 Cell therapy administration with Core decompression Sequential administration of low, medium, and high dose clinical drugs.

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Secondary

Measure	Time frame
X-ray & MRI, Visual analogue scale, Harrise Hip Scores, WOMAC scores	—

Primary

Measure	Time frame
Safety Test (Serious Adverse Event, Adverse Drug Reaction)	—

Countries

Korea, Republic of

Contacts

Public ContactSeung-Hoon Baek

Kyungpook National University Hospital

insideme@paran.com+82-53-200-5633

Outcome results