Implantation of Bone Marrow Cells to Treat Avascular Necrosis of Femoral Head (ANFH)

Control Study of Implantation of Enriched Bone Marrow Cells for the Treatment of Avascular Necrosis of Femoral Head

The purpose of this study is to compare the efficacy of autologous enriched bone marrow cell implantation combined with core decompression to single core decompression for the treatment of avascular necrosis of femoral head.

Study Overview

• Status: Unknown
• Conditions: Avascular Necrosis of Femur Head
• Intervention / Treatment: Procedure: core decompression; Procedure: Enriched BMCs implantation combined with core decompression

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• femoral head necrosis patients
• stage I/II/III (Ficat)
• age from 18 to 55 years
• stop steroid treatment for minimal 6 months

Exclusion Criteria:

• age younger than 18 or older than 55
• any hemopathy
• tumor
• femoral head/neck fracture

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
SHAM_COMPARATOR: control group:core decompression; single core decompression	Procedure: core decompression; minimal surgical invention to drill a core to the femoral head to release pressure
ACTIVE_COMPARATOR: Treatment group: BMCs+core decompression; Enriched bone marrow cells combined with core decompression	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of Visual Analogue Scale	Change from baseline in 24 months	before invention and 24 months after invention
change of lequensne algofunctional index	change from baseline in 24 months	before invention and 24 months after invention
change of WOMAC index	change from baseline in 24 months	before invention and 24 months after invention

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (ANTICIPATED): August 1, 2012
• Study Completion (ANTICIPATED): December 1, 2012

Study Registration Dates

• First Submitted: December 13, 2011
• First Submitted That Met QC Criteria: June 5, 2012
• First Posted (ESTIMATE): June 7, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): August 14, 2012
• Last Update Submitted That Met QC Criteria: August 12, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Musculoskeletal Diseases; Bone Diseases; Necrosis; Osteonecrosis; Femur Head Necrosis
• Other Study ID Numbers: GGH_201112_Ortho_1