Condition category
Musculoskeletal Diseases
Date applied
29/01/2010
Date assigned
09/02/2010
Last edited
09/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Dewei Zhao

ORCID ID

Contact details

No. 6 Jiefang St.
Dalian
116001
China
deweizhao.duzh@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CD-BMMSC-04

Study information

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

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

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)

Study design

Single centre randomised controlled interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

04/03/2004

Overall trial end date

01/09/2011

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

At least 100 patients

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

Trial participating centre

No. 6 Jiefang St.
Dalian
116001
China

Sponsor information

Organisation

Dalian University Zhongshan Hospital (China)

Sponsor details

c/o Dewei Zhao
No.6 Jiefang St.
Dalian
116001
China
deweizhao.duzh@gmail.com

Sponsor type

Hospital/treatment centre

Website

http://www.dlhospital.com/yygk/yyjsyw.htm

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes