Lower Back PainNCT01213953
Isolation and Authentication of Mesenchymal Stem Cell-like Progenitor Cells From the Degenerated Intervertebral Disc of Lumbar Spine
An observational study of Lower Back Pain and Disc Degeneration, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lower Back Pain, Disc Degeneration
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2010to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients received the surgery of discectomy for the degenerative disc.
Who may be able to join
- The adults with disc degeneration（age >= 20 years old） A. Herniated intervertebral disc. B. Spondylolisthesis. C. Spondylolysis. D. Other causes of disc degeneration.
Who cannot join
- Age < 20 years old.
- Pregnancy.
- Spinal tumors.
- Spinal infections.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
We will collect the degenerative disc from adults and isolate the mesenchymal stem cell-like precursors cells. The function of osteogenic, chondrogenic, and lipogenic differentiation will be authenticated. The results will offer the information for cell source of tissue engineering in the future.
- Conditions
- Lower Back Pain, Disc Degeneration
- Keywords
- Vertebral disc, mesenchymal stem cell.
- Medical subject headings
- Low Back Pain, Intervertebral Disc Degeneration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hsieh-Hsing Lee, Principal investigator, Taipei Medical University Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213953
- Sponsor's protocol ID
- 98025
- Status last verified
- Oct 2010
- First submitted
- 1 Oct 2010
- Last updated
- 19 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isolation and Authentication of Mesenchymal Stem Cell-like Progenitor Cells From the Degenerated Intervertebral Disc of Lumbar Spine
- ClinicalTrials.gov ID
- NCT01213953
- Acronym / sponsor ID
- 98025
- Conditions
- Lower Back Pain, Disc Degeneration
- Keywords
- Vertebral disc, mesenchymal stem cell.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 4 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
We will collect the degenerative disc from adults and isolate the mesenchymal stem cell-like precursors cells. The function of osteogenic, chondrogenic, and lipogenic differentiation will be authenticated. The results will offer the information for cell source of tissue engineering in the future.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients received the surgery of discectomy for the degenerative disc.
Key inclusion criteria (1 listed)
- The adults with disc degeneration（age >= 20 years old） A. Herniated intervertebral disc. B. Spondylolisthesis. C. Spondylolysis. D. Other causes of disc degeneration.
Key exclusion criteria (4 listed)
- Age < 20 years old.
- Pregnancy.
- Spinal tumors.
- Spinal infections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsieh-Hsing Lee principal investigator
Taipei Medical University Shuang Ho Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Back Pain and Disc Degeneration, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2010.