Osteoarthritis,KneePhase 1NCT03007576
Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stromal Cell Product (RegStem)
A Phase 1 study testing RegStem in people with Osteoarthritis,Knee, run by EMO Biomedicine Corporation at 1 site in Taiwan.
Trial summary
Osteoarthritis (OA) is a common and incurable disease for the elderly in Taiwan, so it is an important mission to develop a new treatment for OA. Recently, cellular therapy is a new and popular medical treatment around the world, one of them is "Mesenchymal Stromal Cells (MSCs)". Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Osteoarthritis,Knee
- What is being tested?
- RegStem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2017to 31 Aug 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who understand and sign the informed consent form for this study
- Grade 2~3 osteoarthritis according to the Kellgren-Lawrence grading scale with one-month X-ray
- Age is 50~75 years old
- Postmenopausal women
- VAS scores in 50 to 90 mm
Who cannot join
- Abnormal of liver and kidney: GOT and GPT > 100 IU/L, BUN >22 mg/dl and creatinine > 1.2 mg/dl.
- Positive serology for HIV, HTLV-1/2 and syphilis
- Women who are pregnant or breast feeding
- Serious pre-existing medical conditions: coagulation disorders, cardiovascular diseases (arrhythmias, myocardial infarction and surgery), renal diseases (chronic renal failure), liver diseases (cirrhosis), diabetes mellitus type I, cancer history.
- Other joint diseases: knee deformity (knee varus greater than 10 degree or valgus greater than 20 degree), rheumatic arthritis, gouty arthritis, septic arthritis, serious meniscal tear, other autoimmune arthritis.
- Skin inflammatory of knee
Show all 13Show fewer
- Knee pain caused by referred pain from spine disease or hip joint disease. Knee pain combined with pain from spine disease or hip disease.
- Immunosuppressive state
- Subjects who were injected with hyaluronic acid and PRP in the past 6 months
- Body mass index (BMI) greater than 30
- Have a history of allergic reaction of any medication
- Participation in another clinical trial or treatment within 3 months
- Other pathologic conditions or circumstances that difficult participation in this study according to PI's evaluations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Clinical Trial - Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stromal Cell Product (RegStem)
Osteoarthritis (OA) is a common and incurable disease for the elderly in Taiwan, so it is an important mission to develop a new treatment for OA. Recently, cellular therapy is a new and popular medical treatment around the world, one of them is "Mesenchymal Stromal Cells (MSCs)". MSCs are found in many tissues of human body and play an important role for repairing, regeneration, anti-inflammatory and chondrogenesis. So, MSC product, RegStem, for osteoarthritis treatment becomes a developing target for new generation drugs.
This study is to isolate and expand MSCs(RegStem) from infrapatellar fat pad of subject. When the number of MSCs expands to 1×10^8, cell will be cryopreserved in the liquid nitrogen tank until all release tests passed. On the distribution day, cell will be thawed and injected into joint cavity of patient (5×10^7). Subjects will be monitored after MSC product infusion of seven days, one month, six months and one year. The monitoring items include the changes of knee (by appearance, X-ray and MRI of knee) and pain improvement (by questionnaire).
- Conditions
- Osteoarthritis,Knee
- Being tested
- RegStem
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegStemBiological
Also called MSC
RegStem, 1.5 ml, one injection
| Study group | Role | What they receive |
|---|---|---|
| RegStem | Experimental | Autologous MSC, 5×10^7 cells, one injection Receives: Biological: RegStem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of RegStem by incidence of adverse events and changes in physical examinations, vital signs and the results of clinical lab tests.
Measured: 48 weeks
Clinical assessment of International Knee Documentation Committee (IKDC) score
Assess symptoms of knee, sport activity and function of knee
Measured: 48 weeks
Secondary outcomes (4)
Clinical assessment of Knee injury and Osteoarthritis Outcome Score (KOOS)
Measured: 48 weeks
Clinical assessment of visual analogue scale (VAS)
Measured: 48 weeks
Clinical assessment of knee X-ray
Measured: 48 weeks
Clinical assessment of knee MRI
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study start1 Aug 2017
- Primary completion31 Aug 2019
- Study completion31 Aug 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMO Biomedicine Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Far Eastern Memorial Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007576
- Sponsor's protocol ID
- EMOCT01
- Status last verified
- Nov 2019
- First submitted
- 21 Dec 2016
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial - Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stromal Cell Product (RegStem)
- ClinicalTrials.gov ID
- NCT03007576
- Acronym / sponsor ID
- EMOCT01
- Conditions
- Osteoarthritis,Knee
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- EMO Biomedicine CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Far Eastern Memorial Hospital
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 2 Jan 2017 (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 a common and incurable disease for the elderly in Taiwan, so it is an important mission to develop a new treatment for OA. Recently, cellular therapy is a new and popular medical treatment around the world, one of them is "Mesenchymal Stromal Cells (MSCs)". MSCs are found in many tissues of human body and play an important role for repairing, regeneration, anti-inflammatory and chondrogenesis. So, MSC product, RegStem, for osteoarthritis treatment becomes a developing target for new generation drugs.
This study is to isolate and expand MSCs(RegStem) from infrapatellar fat pad of subject. When the number of MSCs expands to 1×10^8, cell will be cryopreserved in the liquid nitrogen tank until all release tests passed. On the distribution day, cell will be thawed and injected into joint cavity of patient (5×10^7). Subjects will be monitored after MSC product infusion of seven days, one month, six months and one year. The monitoring items include the changes of knee (by appearance, X-ray and MRI of knee) and pain improvement (by questionnaire).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RegStem | Experimental | Biological: RegStemAutologous MSC, 5×10^7 cells, one injection |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects who understand and sign the informed consent form for this study
- Grade 2~3 osteoarthritis according to the Kellgren-Lawrence grading scale with one-month X-ray
- Age is 50~75 years old
- Postmenopausal women
- VAS scores in 50 to 90 mm
Key exclusion criteria (13 listed)
- Abnormal of liver and kidney: GOT and GPT > 100 IU/L, BUN >22 mg/dl and creatinine > 1.2 mg/dl.
- Positive serology for HIV, HTLV-1/2 and syphilis
- Women who are pregnant or breast feeding
- Serious pre-existing medical conditions: coagulation disorders, cardiovascular diseases (arrhythmias, myocardial infarction and surgery), renal diseases (chronic renal failure), liver diseases (cirrhosis), diabetes mellitus type I, cancer history.
- Other joint diseases: knee deformity (knee varus greater than 10 degree or valgus greater than 20 degree), rheumatic arthritis, gouty arthritis, septic arthritis, serious meniscal tear, other autoimmune arthritis.
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 |
|---|---|---|
| RegStemAlso: MSCRegStem, 1.5 ml, one injection | Biological | RegStem |
Primary outcome
Safety of RegStem by incidence of adverse events and changes in physical examinations, vital signs and the results of clinical lab tests.
Time frame: 48 weeks
Clinical assessment of International Knee Documentation Committee (IKDC) score
Time frame: 48 weeks
Assess symptoms of knee, sport activity and function of knee
4 secondary outcomes
Clinical assessment of Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 48 weeks
Clinical assessment of visual analogue scale (VAS)
Time frame: 48 weeks
Clinical assessment of knee X-ray
Time frame: 48 weeks
Clinical assessment of knee MRI
Time frame: 48 weeks
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 13 Nov 2019.
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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 RegStem in people with Osteoarthritis,Knee, run by EMO Biomedicine Corporation 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 13 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 13 Nov 2019. 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 RegStem by incidence of adverse events and changes in physical examinations, vital signs and the results of clinical lab tests. (time frame: 48 weeks). The study lists 2 primary outcomes in all. 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 13 Nov 2019.