Osteoarthritis KneePhase 1NCT02544802
Mesenchymal Stem Cell Treatment for Primary Osteoarthritis Knee
A Phase 1 study testing Adipose-Derived Mesenchymal Stem Cells in people with Osteoarthritis Knee, run by Steminent Biotherapeutics Inc. at 1 site in Taiwan.
Trial summary
The purpose of this study is to evaluate the safety and preliminary efficacy of autologous adipose-derived mesenchymal stem cells (ADMSCs) treatment for patients with primary osteoarthritis knee. Three intra-articular injections of autologous ADMSCs will be performed to subjects at a weekly interval. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Osteoarthritis Knee
- What is being tested?
- Adipose-Derived Mesenchymal Stem Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2015to 31 Jan 2019
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has bilateral Kellgren and Lawrence grade II-III primary osteoarthritis as determined by X-ray.
- Subject's pain score is 8-13 points (Lequesne's index).
- Ages between 50-70 years.
- Signed informed consent from the subject.
- Female subjects should be post-menopausal women
Who cannot join
- Subject infected with hepatitis B, hepatitis C, HIV, syphilis or HTLV.
- Subject not suitable for liposuction surgery.
- Subject with hypersensitivity/allergy to anesthetic.
- Subject's creatinine values higher than 1.6mg/dl.
- Subject with body mass index, BMI over 30.
- Subject's studied knee treated with intra-articular injection therapy within 6 months prior to screen.
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- Subject has undergone surgery on either side of knee, including fracture surgery, arthroscopic surgery, meniscus repair surgery, or cruciate ligament reconstruction surgery.
- Subject enrolled in any other cell therapy studies within the past 30 days.
- Subject who the investigator considers inappropriate for the clinical trial due to any other reasons than those listed above.
- Subject has a history of gouty arthritis, septic arthritis, rheumatoid arthritis and any other autoimmune arthritis of the knee joint.
- Subject has had major medical problems in vital organs, such as; heart, liver, kidney, or lung.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Primary Osteoarthritis of the Knee Joint With Autologous Mesenchymal Stem Cells
The purpose of this study is to evaluate the safety and preliminary efficacy of autologous adipose-derived mesenchymal stem cells (ADMSCs) treatment for patients with primary osteoarthritis knee. Three intra-articular injections of autologous ADMSCs will be performed to subjects at a weekly interval.
- Conditions
- Osteoarthritis Knee
- Being tested
- Adipose-Derived Mesenchymal Stem Cells
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose-Derived Mesenchymal Stem CellsDrug
| Study group | Role | What they receive |
|---|---|---|
| ADMSCs | Experimental | Three intra-articular injections of ADMSCs at the dose of 8~10x10^6 cells/injection Receives: Drug: Adipose-Derived Mesenchymal Stem Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of intra-articular injection of autologous ADMSCs by incidence of adverse events and alterations in vital signs, blood chemistry profiles, complete blood count, urinalysis, and also the physical examination of the knees.
Measured: 12 months
Secondary outcomes (6)
Clinical assessment of visual analogue scale (VAS)
Measured: 12 months
Clinical assessment of Short Form 36 questionnaire (SF-36)
Measured: 12 months
Clinical assessment of Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Measured: 12 months
Clinical assessment of Hospital for Special Surgery (HSS) Knee Score
Measured: 12 months
Clinical imaging assessment of knee X-ray
Measured: 12 months
Clinical imaging assessment of MRI of the knee
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startJun 2015
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis KneeStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steminent Biotherapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544802
- Sponsor's protocol ID
- SB-VGH-201102
- Status last verified
- Oct 2022
- First submitted
- 4 Sep 2015
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Primary Osteoarthritis of the Knee Joint With Autologous Mesenchymal Stem Cells
- ClinicalTrials.gov ID
- NCT02544802
- Acronym / sponsor ID
- SB-VGH-201102
- Conditions
- Osteoarthritis Knee
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Steminent Biotherapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 9 Sep 2015 (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 purpose of this study is to evaluate the safety and preliminary efficacy of autologous adipose-derived mesenchymal stem cells (ADMSCs) treatment for patients with primary osteoarthritis knee. Three intra-articular injections of autologous ADMSCs will be performed to subjects at a weekly interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADMSCs | Experimental | Drug: Adipose-Derived Mesenchymal Stem CellsThree intra-articular injections of ADMSCs at the dose of 8~10x10^6 cells/injection |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject has bilateral Kellgren and Lawrence grade II-III primary osteoarthritis as determined by X-ray.
- Subject's pain score is 8-13 points (Lequesne's index).
- Ages between 50-70 years.
- Signed informed consent from the subject.
- Female subjects should be post-menopausal women
Key exclusion criteria (11 listed)
- Subject infected with hepatitis B, hepatitis C, HIV, syphilis or HTLV.
- Subject not suitable for liposuction surgery.
- Subject with hypersensitivity/allergy to anesthetic.
- Subject's creatinine values higher than 1.6mg/dl.
- Subject with body mass index, BMI over 30.
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 |
|---|---|---|
| Adipose-Derived Mesenchymal Stem Cells | Drug | ADMSCs |
Primary outcome
Safety of intra-articular injection of autologous ADMSCs by incidence of adverse events and alterations in vital signs, blood chemistry profiles, complete blood count, urinalysis, and also the physical examination of the knees.
Time frame: 12 months
6 secondary outcomes
Clinical assessment of visual analogue scale (VAS)
Time frame: 12 months
Clinical assessment of Short Form 36 questionnaire (SF-36)
Time frame: 12 months
Clinical assessment of Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 12 months
Clinical assessment of Hospital for Special Surgery (HSS) Knee Score
Time frame: 12 months
Clinical imaging assessment of knee X-ray
Time frame: 12 months
Clinical imaging assessment of MRI of the knee
Time frame: 12 months
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 28 Oct 2022.
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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?
A Phase 1 study testing Adipose-Derived Mesenchymal Stem Cells in people with Osteoarthritis Knee, run by Steminent Biotherapeutics Inc. 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 5 inclusion and 11 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 28 Oct 2022. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Safety of intra-articular injection of autologous ADMSCs by incidence of adverse events and alterations in vital signs, blood chemistry profiles, complete blood count, urinalysis, and also the physical examination of the knees. (time frame: 12 months). 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 28 Oct 2022.