Implantation of Bone Marrow Cells to Treat Avascular Necrosis of Femoral Head (ANFH)
NCT ID: NCT01613612
Last Updated: 2012-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2/PHASE3
60 participants
INTERVENTIONAL
2009-03-31
2012-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
control group:core decompression
single core decompression
core decompression
minimal surgical invention to drill a core to the femoral head to release pressure
Treatment group: BMCs+core decompression
Enriched bone marrow cells combined with core decompression
Enriched BMCs implantation combined with core decompression
Patients are subjected to bone marrow aspiration from the anterior iliac crest. Mononuclear cells are enriched from patients' bone marrow by centrifuge, which are grafted with autologous cortical bone and implanted to the necrotic zone of the femoral head.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
core decompression
minimal surgical invention to drill a core to the femoral head to release pressure
Enriched BMCs implantation combined with core decompression
Patients are subjected to bone marrow aspiration from the anterior iliac crest. Mononuclear cells are enriched from patients' bone marrow by centrifuge, which are grafted with autologous cortical bone and implanted to the necrotic zone of the femoral head.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* stage I/II/III (Ficat)
* age from 18 to 55 years
* stop steroid treatment for minimal 6 months
Exclusion Criteria
* any hemopathy
* tumor
* femoral head/neck fracture
18 Years
55 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Guangdong Provincial People's Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Qiujiang Zheng
Director of Orthopaedic Surgery
References
Explore related publications, articles, or registry entries linked to this study.
Li M, Ma Y, Fu G, Zhang R, Li Q, Deng Z, Zheng M, Zheng Q. 10-year follow-up results of the prospective, double-blinded, randomized, controlled study on autologous bone marrow buffy coat grafting combined with core decompression in patients with avascular necrosis of the femoral head. Stem Cell Res Ther. 2020 Jul 16;11(1):287. doi: 10.1186/s13287-020-01810-8.
Ma Y, Wang T, Liao J, Gu H, Lin X, Jiang Q, Bulsara MK, Zheng M, Zheng Q. Efficacy of autologous bone marrow buffy coat grafting combined with core decompression in patients with avascular necrosis of femoral head: a prospective, double-blinded, randomized, controlled study. Stem Cell Res Ther. 2014 Oct 14;5(5):115. doi: 10.1186/scrt505.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GGH_201112_Ortho_1
Identifier Type: -
Identifier Source: org_study_id