Osteoarthritis of the KneePhase 1/2NCT03166865
Clinical Study of Umbilical Cord Mesenchymal Stem Cells (UC-MSC) for Treatment of Knee Osteoarthritis
A Phase 1/2 study testing Umbilical-cord mesenchymal stromal cells (UC-MSCs) and Hyaluronic acid in people with Osteoarthritis of the Knee, run by Liaocheng People's Hospital at 1 site in China.
Trial summary
Osteoarthritis (OA) is one of the most common joint diseases that is considered a chronic degenerative disorder. There is no effective therapy available today. This prospective clinical trial is designed in an attempt to study the efficacy of mesenchymal stem cells with platelet rich plasma in knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Umbilical-cord mesenchymal stromal cells (UC-MSCs) and Hyaluronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2018to 1 Oct 2020
- Phase
- Phase 1/2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 30-70 years old.
- No serious infection, chronic diseases, diabetes and tuberculosis.
- Osteoarthritis of the knee with grade1-3 defined by the modified Kellgren-Lawrence classification.
- Written informed consents were obtained from all subjects.
Who cannot join
- Pregnant women or cognitively impaired adults.
- Inflammatory or post infectious arthritis.
- Intra-articular drug injection within the previous 2 months.
- Serious medical illness with a life expectancy of less than 1 year.
- Prior admission for substance abuse.
- Arthroscopy during the previous 6 months.
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- Systemic autoimmune rheumatic disease.
- Poorly controlled diabetes mellitus.
- Immunosuppressive or anticoagulant treatments.
- Treatment with corticosteroids in the 3 months prior to inclusion in the study.
- NSAID therapy within 15 days prior to inclusion in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Liaocheng city people's hospital
Liaocheng, Shandong, 0635
Changhui Zhou, Ph.D., 86-0635-8272202, zhouchanghui008@163.com
About this study
Osteoarthritis (OA) is one of the most common joint diseases that is considered a chronic degenerative disorder. There is no effective therapy available today. This prospective clinical trial is designed in an attempt to study the efficacy of mesenchymal stem cells with platelet rich plasma in knee osteoarthritis.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Umbilical-cord mesenchymal stromal cells (UC-MSCs), Hyaluronic acid
- Keywords
- osteoarthritis (OA), mesenchymal stem cells(MSC)
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical-cord mesenchymal stromal cells (UC-MSCs)Biological
Allogeneic UC-MSCs 1 x 10~7 diluted on 5 mL of Platelet Rich Plasma
Hyaluronic acidOther
intra-articular injection of Hyaluronic Acid
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intraarticular injection of 2×10~7 Umbilical-cord mesenchimal stem cells with plateler Rich Plasma(5ml) Receives: Biological: Umbilical-cord mesenchymal stromal cells (UC-MSCs) |
| Control group | Other | Intraarticular injection of hyaluronic acid Receives: Other: Hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in visual analogue scale (VAS)
Visual analogue scale (VAS)
Measured: Baseline, 1, 3, 6 and 12 weeks
Change From Baseline in western Ontario and McMaster Universities Osteoarthritis Index score
WOMAC
Measured: Baseline, 1, 3, 6 and 12 weeks
Change From Baseline in knee society score (KSS)
knee society score (KSS)
Measured: Baseline, 1, 3, 6 and 12 weeks
Change From Baseline in MOS item short from health survey(SF-36)
The MOS item short from health survey(SF-36)
Measured: Baseline, 1, 3, 6 and 12 weeks
Secondary outcomes (2)
The number of cartilage defects, thickness of cartilage evaluated by X-ray and MRI
Measured: Baseline, 1, 3, 6 and 12 weeks
The IL-1β, IL-6, PGE-2, TGF-β, TNF-α and IGF-1 of articular cavity fluid
The IL-1β, IL-6, PGE-2, TGF-β, TNF-α and IGF-1 of articular cavity fluid
Measured: Baseline, 1, 3, 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start1 Oct 2018 (estimated)
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaocheng People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dawang Wang, Ph.D., Study director, Liaocheng People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166865
- Sponsor's protocol ID
- lcsrmyygk
- Status last verified
- Jun 2018
- First submitted
- 23 May 2017
- Last updated
- 4 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Umbilical Cord Mesenchymal Stem Cells (UC-MSC) for Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03166865
- Acronym / sponsor ID
- lcsrmyygk
- Conditions
- Osteoarthritis of the Knee
- Keywords
- osteoarthritis (OA), mesenchymal stem cells(MSC)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Liaocheng People's HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 25 May 2017 (actual)
- 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 common joint diseases that is considered a chronic degenerative disorder. There is no effective therapy available today. This prospective clinical trial is designed in an attempt to study the efficacy of mesenchymal stem cells with platelet rich plasma in knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Biological: Umbilical-cord mesenchymal stromal cells (UC-MSCs)Intraarticular injection of 2×10~7 Umbilical-cord mesenchimal stem cells with plateler Rich Plasma(5ml) |
| Control group | Other | Other: Hyaluronic acidIntraarticular injection of hyaluronic acid |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 30-70 years old.
- No serious infection, chronic diseases, diabetes and tuberculosis.
- Osteoarthritis of the knee with grade1-3 defined by the modified Kellgren-Lawrence classification.
- Written informed consents were obtained from all subjects.
Key exclusion criteria (11 listed)
- Pregnant women or cognitively impaired adults.
- Inflammatory or post infectious arthritis.
- Intra-articular drug injection within the previous 2 months.
- Serious medical illness with a life expectancy of less than 1 year.
- Prior admission for substance abuse.
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 |
|---|---|---|
| Umbilical-cord mesenchymal stromal cells (UC-MSCs)Allogeneic UC-MSCs 1 x 10~7 diluted on 5 mL of Platelet Rich Plasma | Biological | Intervention group |
| Hyaluronic acidintra-articular injection of Hyaluronic Acid | Other | Control group |
Primary outcome
Change From Baseline in visual analogue scale (VAS)
Time frame: Baseline, 1, 3, 6 and 12 weeks
Visual analogue scale (VAS)
Change From Baseline in western Ontario and McMaster Universities Osteoarthritis Index score
Time frame: Baseline, 1, 3, 6 and 12 weeks
WOMAC
Change From Baseline in knee society score (KSS)
Time frame: Baseline, 1, 3, 6 and 12 weeks
knee society score (KSS)
Change From Baseline in MOS item short from health survey(SF-36)
Time frame: Baseline, 1, 3, 6 and 12 weeks
The MOS item short from health survey(SF-36)
2 secondary outcomes
The number of cartilage defects, thickness of cartilage evaluated by X-ray and MRI
Time frame: Baseline, 1, 3, 6 and 12 weeks
The IL-1β, IL-6, PGE-2, TGF-β, TNF-α and IGF-1 of articular cavity fluid
Time frame: Baseline, 1, 3, 6 and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
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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.
Dawang Wang, Ph.D. study director
Liaocheng People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Umbilical-cord mesenchymal stromal cells (UC-MSCs) and Hyaluronic acid in people with Osteoarthritis of the Knee, run by Liaocheng People's Hospital at 1 site in China.
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 4 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: status not confirmed, as of the sponsor's last update on 4 Jun 2018. 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 China. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Changhui Zhou, Ph.D. (86-0635-8272202, zhouchanghui008@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in visual analogue scale (VAS) (time frame: Baseline, 1, 3, 6 and 12 weeks). The study lists 4 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 4 Jun 2018.