Mesenchymal Stem CellsNCT01301664
Cartilage Tissue Engineering
A study testing total knee / hip replacement in people with Mesenchymal Stem Cells, run by Chin-Hung Chang.
Trial summary
In this study, the investigators explored the hypothesis that osteoarthritic cartilage fragments can promote chondrogenesis of MSCs. Non-wearing parts of cartilage tissues were harvested from one osteoarthritic patient during the total knee arthroplasty surgery. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Mesenchymal Stem Cells
- What is being tested?
- total knee / hip replacement
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 30 to 70 years
- All sexes
- Adult, Older adult
Who may be able to join
- 30-70 years old
Who cannot join
- more than 70 years old
Trial locations and contacts
No sites are listed yet.
Chia-Chun Chen, Master contact
About this study
In this study, the investigators explored the hypothesis that osteoarthritic cartilage fragments can promote chondrogenesis of MSCs. Non-wearing parts of cartilage tissues were harvested from one osteoarthritic patient during the total knee arthroplasty surgery. Cartilage fragments and MSCs were wrapped into fibrin glue; and the constructs were implanted subcutaneously into nude mice.
Moreover, the investigators will collect the discard cartilage to develop an acellular cartilage ECM-derived scaffold in the joint replacement surgery. In addition, the investigators will harvest the redundant bone marrow from drilling or useless synovium during the surgery to separate the mesenchymal stem cells. Furthermore, these mesenchymal stem cells will be transfected with hTERT for rejuvenation and then will be labeled with fluorescent dye PKH26 for application of animal study. To sum up, the investigators plan to use human, natural, and discard materials from the joint replacement surgery to develop appropriate allograft for cartilage repair and hope that one day this ideal would be apply in clinical.
Read the detailed description
Extracellular matrix (ECM) is thought to participate significantly in guiding the differentiation process of mesenchymal stem cells (MSCs). In this study, we explored the hypothesis that osteoarthritic cartilage matrix can promote chondrogenesis of MSCs. Cartilage matrix was harvested from the health-like parts of osteoarthritic cartilage tissue. Cartilage fragments and MSCs were wrapped into fibrin glue; and the constructs were implanted subcutaneously into nude mice. Histological analysis showed a round and elongated cell appearance with positive Alcian blue staining of cartilage matrix formation in the constructs. However, the cells in fibrin glue only were condensed like MSCs in pellet culture. Immunohistochemical staining was abundantly positive for type II collagen in neo-cartilage regions of cartilage fragment-fibrin glue-MSC constructs, while the constructs without cartilage fragments were negative in staining for type II collagen. The gene expressions of type II collagen in the constructs with 60 mg fragments were significantly elevated after 4 weeks of implantation. Conversely, constructs without cartilage fragments failed to express type II collagen, which indicated that MSCs could not differentiate into a chondrogenic lineage. In conclusion, we demonstrated the effects of osteoarthritic cartilage matrix in promoting chondrogenic differentiation of MSCs. This was a favorable method without exogenous growth factors induction.
- Conditions
- Mesenchymal Stem Cells
- Being tested
- total knee / hip replacement
- Keywords
- The bone marrow-derived mesenchymal stem cells (BMMSCs) were obtained from redundant bone marrow from drilling during the joint replacement surgery., The synovial-derived mesenchymal stem cells (SMSCs) were isolated from synovial membranes in the joint replacement surgery., Cartilage slices were obtained from discard cartilage in the joint replacement surgery.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total knee / hip replacementOther
Human cartilage tissues were harvested from osteoarthritic patient during total knee arthroplasty surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mesenchymal Stem CellsStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Chin-Hung Chang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chin-Hung Chang, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301664
- Sponsor's protocol ID
- 97022
- Status last verified
- Mar 2013
- First submitted
- 5 Oct 2010
- Last updated
- 7 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cartilage Tissue Engineering
- ClinicalTrials.gov ID
- NCT01301664
- Acronym / sponsor ID
- 97022
- Conditions
- Mesenchymal Stem Cells
- Keywords
- The bone marrow-derived mesenchymal stem cells (BMMSCs) were obtained from redundant bone marrow from drilling during the joint replacement surgery., The synovial-derived mesenchymal stem cells (SMSCs) were isolated from synovial membranes in the joint replacement surgery., Cartilage slices were obtained from discard cartilage in the joint replacement surgery.
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Chin-Hung ChangUniversity, hospital or other
- First posted
- 23 Feb 2011 (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.
In this study, the investigators explored the hypothesis that osteoarthritic cartilage fragments can promote chondrogenesis of MSCs. Non-wearing parts of cartilage tissues were harvested from one osteoarthritic patient during the total knee arthroplasty surgery. Cartilage fragments and MSCs were wrapped into fibrin glue; and the constructs were implanted subcutaneously into nude mice.
Moreover, the investigators will collect the discard cartilage to develop an acellular cartilage ECM-derived scaffold in the joint replacement surgery. In addition, the investigators will harvest the redundant bone marrow from drilling or useless synovium during the surgery to separate the mesenchymal stem cells. Furthermore, these mesenchymal stem cells will be transfected with hTERT for rejuvenation and then will be labeled with fluorescent dye PKH26 for application of animal study. To sum up, the investigators plan to use human, natural, and discard materials from the joint replacement surgery to develop appropriate allograft for cartilage repair and hope that one day this ideal would be apply in clinical.
Detailed description
Extracellular matrix (ECM) is thought to participate significantly in guiding the differentiation process of mesenchymal stem cells (MSCs). In this study, we explored the hypothesis that osteoarthritic cartilage matrix can promote chondrogenesis of MSCs. Cartilage matrix was harvested from the health-like parts of osteoarthritic cartilage tissue. Cartilage fragments and MSCs were wrapped into fibrin glue; and the constructs were implanted subcutaneously into nude mice. Histological analysis showed a round and elongated cell appearance with positive Alcian blue staining of cartilage matrix formation in the constructs. However, the cells in fibrin glue only were condensed like MSCs in pellet culture. Immunohistochemical staining was abundantly positive for type II collagen in neo-cartilage regions of cartilage fragment-fibrin glue-MSC constructs, while the constructs without cartilage fragments were negative in staining for type II collagen. The gene expressions of type II collagen in the constructs with 60 mg fragments were significantly elevated after 4 weeks of implantation. Conversely, constructs without cartilage fragments failed to express type II collagen, which indicated that MSCs could not differentiate into a chondrogenic lineage. In conclusion, we demonstrated the effects of osteoarthritic cartilage matrix in promoting chondrogenic differentiation of MSCs. This was a favorable method without exogenous growth factors induction.
Study design
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 30-70 years old
Key exclusion criteria (1 listed)
- more than 70 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| total knee / hip replacementHuman cartilage tissues were harvested from osteoarthritic patient during total knee arthroplasty surgery. | Other | – |
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 7 Mar 2013.
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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.
Chia-Chun Chen, Master contact
Questions about this trial
What is this clinical trial studying?
A study testing total knee / hip replacement in people with Mesenchymal Stem Cells, run by Chin-Hung Chang.
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 1 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 7 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Chia-Chun Chen, Master (chia_chun_@hotmail.com), or a site near the patient. 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 7 Mar 2013.