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Therapeutic Effects of Autologous Adipose Tissue-Derived Stromal Vascular Fraction (ADSVF) Implantation for Non-traumatic Osteonecrosis of the Femoral Head: A Double-Blind Randomized Clinical Study with or without ADSVF.

Therapeutic Effects of Autologous Adipose Tissue-Derived Stromal Vascular Fraction (ADSVF) Implantation for Non-traumatic Osteonecrosis of the Femoral Head: A Double-Blind Randomized Clinical Study with or without ADSVF.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0009312
Enrollment
40
Registered
2024-04-05
Start date
2024-04-01
Completion date
Unknown
Last updated
2024-04-29

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, Stem Cell : Multiploe drilling 1. ADSVF one time 3 ml femoral head injection 2. Normal saline one time 3 ml femoral head injection

Sponsors

Hyundae Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Subjects with non-traumatic femoral head avascular necrosis who consent to this study - Subjects who have not received other treatments such as core decompression and multiple trepanation for avascular necrosis of the femoral head in the relevant area - Before the femoral head collapses or when the depth of collapse is less than 2 mm - Subjects with more than 30% necrosis of the femoral head

Exclusion criteria

Exclusion criteria: - Subjects with a depth of femoral head collapse of 2 mm or more - Subjects with more than 30% necrosis of the femoral head - Subjects who have received treatment of core decompression and multiple trepanation for avascular necrosis of the femoral head in the relevant area - Subjects taking osteoporosis treatments such as bisphosphonates or parathyroid hormones - Subjects who are taking immunosuppressants or cytotoxic agents or who need to take them during the test period - Subjects who must continuously take corticosteroids for treatment purposes - Subjects who are unable to undergo MRI (magnetic resonance imaging) due to artificial pacemakers, metallic hip joints, prosthetics, etc. - Subjects who are pregnant or breastfeeding - Subjects currently suffering from infectious diseases including HIV and hepatitis - Subjects with serious diseases that may affect this clinical trial: cardiovascular disease, tumor, kidney disease, endocrine disease such as decreased bone metabolism, increased bone metabolism and thyroid disease, autoimmune disease, etc. - Subjects who participated in another clinical trial within 3 months of participating in this clinical trial - In other cases where the researcher determines that participation in this study is inappropriate

Design outcomes

Primary

MeasureTime frame
Conversion rate to Total hip treplacement

Secondary

MeasureTime frame
1. To find out whether osteonecrotic lesions in the femoral head change and decrease in size or disappear. 2. Harris Hip Score , The Western Ontario and McMaster Universities Arthritis Index, University of California Los Angeles Score

Countries

Korea, Republic of

Contacts

Public ContactKang Sup Yoon

Hyundae Hospital

ksyoon@snu.ac.kr+82-31-574-9119

Outcome results

None listed

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