Treatment of early stage osteonecrosis of the femoral head with implantation of autologous bone marrow-derived and cultured mesenchymal stem cells

ISRCTN	ISRCTN18167626
DOI	https://doi.org/10.1186/ISRCTN18167626
Secondary identifying numbers	CD-BMMSC-04

Submission date: 29/01/2010
Registration date: 09/02/2010
Last edited: 09/02/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Contact information

Dr Dewei Zhao
Scientific

No. 6 Jiefang St.
Dalian
116001
China

Email	deweizhao.duzh@gmail.com

Study information

Study design	Single centre randomised controlled interventional trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Treatment of early stage osteonecrosis of the femoral head with implantation of autologous bone marrow-derived and cultured mesenchymal stem cells: a single centre randomised controlled interventional trial
Study acronym	CD-BMMSC treatment
Study hypothesis	Bone marrow-derived mesenchymal stem cell implantation into the femoral head is effective in treating early stage osteonecrosis of the femoral head, and the number of these mesenchymal stem cells implanted is crucial to the clinical outcome. The hypothesis of this study is to isolate bone marrow mesenchymal stem cells and grow them in vitro to obtain greater number of such cells for femoral head implantation, in order to achieve better clinical outcome.
Ethics approval(s)	Approved by the Public Health Bureau, the City of Dalian, and the State FDA, China in 2002 (ref: 02-88), 2005 (ref: 05-183) and 2008 (ref: 08-179)
Condition	Osteonecrosis of the femoral head at early stage
Intervention	Osteonecrosis of the femoral head remains a significant health concern. Currently, core decompression combined with implantation of autologous bone marrow mononuclear cells appears to be an effective treatment against this disease in the early stage. Among the bone morrow mononuclear cells, mesenchymal stem cells (MSCs) are crucial to the efficacy. The number of mesenchymal stem cells (MSCs) in the bone marrow mononuclear cells is very limited, which are crucial to the efficacy of the treatment. Therefore, the aim of our trial is to obtain greater number of bone marrow MSCs through culturing bone marrow-derived mesenchymal stem cells in vitro, and transplant these cultured bone marrow MSCs into the affected femoral head following the procedure of core decompression. In our procedure, about two million cultured bone marrow MSCs could be implanted into the femoral head, compared with that about 20 - 25 thousand MSCs implanted into the femoral head in the procedure employed by other groups, therefore, we expect our procedure could lead to higher clinical and radiographic success rate and better clinical outcome. Procedure: 1. Isolate mesenchymal stem cells from the autologous bone marrow mononuclear cells 2. The patients are treated with core decompression 3. The cultured stem cells are injected into the femoral head The duration of our treatment is about 2 weeks. Bone marrow aspiration is performed in the same day of the surgery core decompression, then autologous bone marrow-derived and cultured mesenchymal stem cells are transplanted into the femoral head two weeks post-operatively. The patient enrolment period was designed from 04 March 2004 to 01 September 2011. Our first manuscript will report the outcome by the 30-month follow-up. We will keep following up the patients as long as we can, at least for 8 years.
Intervention type	Other
Primary outcome measure	Clinical outcome, assessed by the Harris Hip Score, measured pre-operatively and at 3 months, 6 months, 12 months, 30 months, and every 2 years post-operatively thereafter
Secondary outcome measures	Radiographic approaches are used to determine the progress in osteonecrotic stage and to assess the volume of the necrotic lesion in the femoral head, measured pre-operatively and at 3 months, 6 months, 12 months, 30 months, and every 2 years post-operatively thereafter
Overall study start date	04/03/2004
Overall study end date	01/09/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	At least 100 patients
Participant inclusion criteria	1. Aged between 18 to 45 years, either sex 2. Patients with hips at stages IC to IIC according to Association Research Circulation Osseous (ARCO) classification 3. Etiological factors including trauma, alcohol abuse, corticosteroid use, Caisson disease, hyperlipidemia, and idiopathic
Participant exclusion criteria	1. Pregnancy 2. Current and previous infection 3. Skeletal immaturity 4. Immunosuppressive drug therapy 5. A history of inflammatory arthritis 6. Evidence of cardiovascular diseases 7. Prior systemic corticosteroid treatment 8. Mental health problems preventing adequate follow-up
Recruitment start date	04/03/2004
Recruitment end date	01/09/2011

Locations

Countries of recruitment

China

Study participating centre

No. 6 Jiefang St.

Dalian
116001
China

Sponsor information

Dalian University Zhongshan Hospital (China)
Hospital/treatment centre

c/o Dewei Zhao
No.6 Jiefang St.
Dalian
116001
China

Email	deweizhao.duzh@gmail.com
Website	http://www.dlhospital.com/yygk/yyjsyw.htm
"ROR"	https://ror.org/041ts2d40

Funders

Funder type

Government

China National Natural Science Foundation (China) (ref: grant 30471752 and 30670542)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan