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

Primary Purpose

Avascular Necrosis of Femur Head

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

core decompression

Enriched BMCs implantation combined with core decompression

About this trial

This is an interventional treatment trial for Avascular Necrosis of Femur Head

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

control group:core decompression

Treatment group: BMCs+core decompression

Arm Description

single core decompression

Enriched bone marrow cells combined with core decompression

Outcomes

Primary Outcome Measures

change of Visual Analogue Scale

Change from baseline in 24 months

change of lequensne algofunctional index

change from baseline in 24 months

change of WOMAC index

change from baseline in 24 months

Secondary Outcome Measures

Full Information

NCT ID

NCT01613612

First Posted

December 13, 2011

Last Updated

August 12, 2012

Sponsor

Guangdong Provincial People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01613612

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Unknown status

Study Start Date

March 2009 (undefined)

Primary Completion Date

August 2012 (Anticipated)

Study Completion Date

December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guangdong Provincial People's Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Avascular Necrosis of Femur Head

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

control group:core decompression

Arm Type

Sham Comparator

Arm Description

single core decompression

Arm Title

Treatment group: BMCs+core decompression

Arm Type

Active Comparator

Arm Description

Enriched bone marrow cells combined with core decompression

Intervention Type

Procedure

Intervention Name(s)

core decompression

Intervention Description

minimal surgical invention to drill a core to the femoral head to release pressure

Intervention Type

Procedure

Intervention Name(s)

Enriched BMCs implantation combined with core decompression

Intervention Description

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.

Primary Outcome Measure Information:

Title

change of Visual Analogue Scale

Description

Change from baseline in 24 months

Time Frame

before invention and 24 months after invention

Title

change of lequensne algofunctional index

Description

change from baseline in 24 months

Time Frame

before invention and 24 months after invention

Title

change of WOMAC index

Description

change from baseline in 24 months

Time Frame

before invention and 24 months after invention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Citations:

PubMed Identifier

32678055

Citation

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.

Results Reference

derived

PubMed Identifier

25315149

Citation

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.

Results Reference

derived

Learn more about this trial

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

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