OsteoarthritisNCT01038596
Mesenchymal Stromal Cells and Osteoarthritis
An observational study of Osteoarthritis, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
Osteoarthritis (OA) is one of the most frequent musculoskeletal disorders and represents the main indication for total joint arthroplasty. Multipotent mesenchymal stromal cells (MSCs) can be easily isolated and culture expanded from bone marrow aspirates and provide an excellent source of progenitor cells for… Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2009to Dec 2016
- 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 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: pelvic compartment advanced-stage (Kellgren and Lawrence grade 3 or 4, mean 67±6 years) osteoarthritic and age-matched healthy donors
Who may be able to join
- indication for hip THR
- primary osteoarthritis of the hip
- Patient's consent
Who cannot join
- secondary osteoarthritis of the hip
- Any malignancies
- infectious disease
- rheumatic disease
- osteoporosis
- Any additional serious disease complicating the participation in this study
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Dresden, Orthopaedic Department
Dresden, 01307
About this study
Official title: Proliferation and Osteogenic Differentiation of Bone Marrow-derived Mesenchymal Stromal Cells From Osteoarthritic Versus Healthy Donors
Osteoarthritis (OA) is one of the most frequent musculoskeletal disorders and represents the main indication for total joint arthroplasty. Multipotent mesenchymal stromal cells (MSCs) can be easily isolated and culture expanded from bone marrow aspirates and provide an excellent source of progenitor cells for cell-based regeneration strategies due to their ex vivo differentiation and proliferation capacity. Although there are hints that MSCs derived from OA patients may exhibit altered function the role of MSCs with respect to disease development and progression of OA is not clearly understood to date. To assess whether advanced-stage OA affects MSCs' suitability for musculoskeletal regenerative therapy, in the present study, we compare proliferation and differentiation potential of MSCs from osteoarthritic versus healthy donors.
Read the detailed description
Clinical data (range of motion of lower limb joints, sociodemographic score dataset, WOMAC score, EQ-5D score, Harris Hip Score, radiological evaluation (OA group only), routine laboratory parameters, and bone metabolism parameters)
Osteogenic, chondrogenic, and adipogenic differentiation is proofed qualitatively by cell staining
osteogenic, chondrogenic and adipogenic marker gene expression analysis using quantitative real-time RT-PCR
cell-specific alkaline phosphatase (ALP) activity assay
large-scale gene expression profile
Fluorescence-activated cell sorting (FACS)- CD44, CD105 (SH2; endoglin), CD106 (vascular cell adhesion molecule; VCAM-1), CD166, CD29, CD73 (SH3 and SH4), CD90 (Thy-1), CD117, STRO-1 and Sca-1 [%]
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, mesenchymal stromal cells, proliferation
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| osteoarthritic donors | pelvic compartment advanced-stage (Kellgren and Lawrence grade 3 or 4) osteoarthritic donors | |
| healthy donors | age-matched healthy donors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Gene expression profile of bone marrow-derived mesenchymal stromal cells from osteoarthritic versus healthy donors
Measured: after msc isolation
Secondary outcomes (1)
Flow cytometric analysis of cell surface antigens, Alkaline phosphatase activity, DNA content as measure for cellular proliferation
Measured: variable 2 days up to 21 days after msc cultivation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startJan 2009
- Primary completionJun 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038596
- Sponsor's protocol ID
- HipMSC-Osteoarthritis
- Status last verified
- Apr 2017
- First submitted
- 23 Dec 2009
- Last updated
- 14 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proliferation and Osteogenic Differentiation of Bone Marrow-derived Mesenchymal Stromal Cells From Osteoarthritic Versus Healthy Donors
- ClinicalTrials.gov ID
- NCT01038596
- Acronym / sponsor ID
- HipMSC-Osteoarthritis
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, mesenchymal stromal cells, proliferation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Jan 2009
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 24 Dec 2009 (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.
Osteoarthritis (OA) is one of the most frequent musculoskeletal disorders and represents the main indication for total joint arthroplasty. Multipotent mesenchymal stromal cells (MSCs) can be easily isolated and culture expanded from bone marrow aspirates and provide an excellent source of progenitor cells for cell-based regeneration strategies due to their ex vivo differentiation and proliferation capacity. Although there are hints that MSCs derived from OA patients may exhibit altered function the role of MSCs with respect to disease development and progression of OA is not clearly understood to date. To assess whether advanced-stage OA affects MSCs' suitability for musculoskeletal regenerative therapy, in the present study, we compare proliferation and differentiation potential of MSCs from osteoarthritic versus healthy donors.
Detailed description
Clinical data (range of motion of lower limb joints, sociodemographic score dataset, WOMAC score, EQ-5D score, Harris Hip Score, radiological evaluation (OA group only), routine laboratory parameters, and bone metabolism parameters)
Osteogenic, chondrogenic, and adipogenic differentiation is proofed qualitatively by cell staining
osteogenic, chondrogenic and adipogenic marker gene expression analysis using quantitative real-time RT-PCR
cell-specific alkaline phosphatase (ALP) activity assay
large-scale gene expression profile
Fluorescence-activated cell sorting (FACS)- CD44, CD105 (SH2; endoglin), CD106 (vascular cell adhesion molecule; VCAM-1), CD166, CD29, CD73 (SH3 and SH4), CD90 (Thy-1), CD117, STRO-1 and Sca-1 [%]
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| osteoarthritic donors | – | –pelvic compartment advanced-stage (Kellgren and Lawrence grade 3 or 4) osteoarthritic donors |
| healthy donors | – | –age-matched healthy donors |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- pelvic compartment advanced-stage (Kellgren and Lawrence grade 3 or 4, mean 67±6 years) osteoarthritic and age-matched healthy donors
Key inclusion criteria (3 listed)
- indication for hip THR
- primary osteoarthritis of the hip
- Patient's consent
Key exclusion criteria (6 listed)
- secondary osteoarthritis of the hip
- Any malignancies
- infectious disease
- rheumatic disease
- osteoporosis
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
Global Gene expression profile of bone marrow-derived mesenchymal stromal cells from osteoarthritic versus healthy donors
Time frame: after msc isolation
1 secondary outcome
Flow cytometric analysis of cell surface antigens, Alkaline phosphatase activity, DNA content as measure for cellular proliferation
Time frame: variable 2 days up to 21 days after msc cultivation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Osteoarthritis, run by Technische Universität Dresden at 1 site in Germany.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 14 Apr 2017. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Global Gene expression profile of bone marrow-derived mesenchymal stromal cells from osteoarthritic versus healthy donors (time frame: after msc isolation). It is what the study was designed to measure, not a finding.
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 14 Apr 2017.