NCT01213953

Brief Summary

The study is designed for evaluating the presence of mesenchymal stem cells of vertebral disc. Isolation and authentication of these cells may be applied for the vertebral disc regeneration and the research tissue engineering.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 1, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

October 19, 2010

Status Verified

October 1, 2010

Enrollment Period

1.1 years

First QC Date

October 1, 2010

Last Update Submit

October 18, 2010

Conditions

Lower Back PainDisc Degeneration

Keywords

Vertebral disc, mesenchymal stem cell.

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The patients received the surgery of discectomy for the degenerative disc.

You may qualify if:

  • The adults with disc degeneration（age \>= 20 years old） A. Herniated intervertebral disc. B. Spondylolisthesis. C. Spondylolysis. D. Other causes of disc degeneration.

You may not qualify if:

  • Age \< 20 years old.
  • Pregnancy.
  • Spinal tumors.
  • Spinal infections.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University - WanFang Hospital

Taipei, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The biospecimen is the tissue waste after the surgery of discectomy.

MeSH Terms

Conditions

Low Back PainIntervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Hsieh-Hsing Lee

    Taipei Medical University Shuang Ho Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 1, 2010

First Posted

October 4, 2010

Study Start

September 1, 2010

Primary Completion

October 1, 2011

Study Completion

December 1, 2011

Last Updated

October 19, 2010

Record last verified: 2010-10

Locations

TW(1)