Osteoarthritis, KneeEarly Phase 1MSCNCT04326985
RCT Mesenchymal Stem Cells Versus Hyaluronic Acid in OA Knee):
A Early Phase 1 study testing Autologous Mesenchymal Stem Cells Treatment (MSCs) and Hyaluronic acid (HA) in people with Osteoarthritis, Knee, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The purpose of this study is to evaluate the therapeutic effect of adult autologous mesenchymal stem cells (abbreviated as MSCs) in patients with osteoarthritic knee and compare to intra articular injection of Synvisc-One. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Autologous Mesenchymal Stem Cells Treatment (MSCs) and Hyaluronic acid (HA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- 31 Jan 2015to 28 Feb 2019
- Phase
- Early 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects aged between 18 and < 65
- Radiological evidence of osteoarthritis with Kellgren and Lawrence grade 2 and 3
- Patients on a pain level equal to or higher than 5 on a VAS scale of 10
Who cannot join
- Previous cases of alcoholism or drug abuse
- Pregnancy and breast-feeding
- Serious pathologies such as carcinoma or autoimmune disease
- Hypersensitivity toward Hyaluorinc Acid
- Undergoing steroid-based systemic therapy or interrupted since less than 1 month
- Significant hematologic diseases
- Mechanical instability, ligamentous laxity/deficiency or gross deformity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Control Clinical Trial to Evaluate the Efficacy of Intra-articular Injections of Mesenchymal Stem Cells Versus Hyaluronic Acid in Patients Affected by Osteoarthritis of the Knee
The purpose of this study is to evaluate the therapeutic effect of adult autologous mesenchymal stem cells (abbreviated as MSCs) in patients with osteoarthritic knee and compare to intra articular injection of Synvisc-One.
Read the detailed description
Study Participants:
This study will involve patients affected by osteoarthritis who comply with the inclusion and exclusion criteria. 30 patients, between the age of 18 and <65, will be enrolled in the study and randomized into three groups to receive either an injection of MSCs, hyaluronic acid (HA) or no injection.
Type of Study: This is a randomized control study.
Treatment method: Each patient will randomly be assigned to one of the following treatment groups:
Group A) Mesenchymal stem cells (MSCs) Group B) Hyaluronic acid (HA) Group C) No injection
Treatment:
Group A) Autologous Mesenchymal Stem Cells Treatment (MSCs) The MSCs treatment group patients will receive an intra-articular injection of a mesenchymal stem cell (MSCs) suspension in the affected knee.
The treatment will be carried out after the patient has received a blood test and clinically evaluated at T0.
T0: Beginning of the study, blood test and bone marrow aspiration. T30: Intra-articular injection of MSCs T44: Adverse events follow up 2 weeks after intra-articular injection (by phone)
Group B) Hyaluronic acid (HA) The patient will be given a single intra-articular injection of hyaluronic acid sodium salt, Synvisc-One (TRB Chemedica Ltd.) The hyaluronic acid will be purchased for the patient from the manufacturer or from the pharmacy of the hospital.
The intra-articular injection will be carried out after the patient has received a clinical evaluation at T0.
T0: Beginning of the study T30: Intra-articular injection of Synvisc-One (HA) T44: Adverse events follow up 2 weeks after intra-articular injection (by phone)
- Conditions
- Osteoarthritis, Knee
- Being tested
- Autologous Mesenchymal Stem Cells Treatment (MSCs), Hyaluronic acid (HA)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Mesenchymal Stem Cells Treatment (MSCs)Biological
The MSCs treatment group patients will receive an intra-articular injection of a mesenchymal stem cell (MSCs) suspension in the affected knee.
Hyaluronic acid (HA)Drug
The HA group patient will be given a single intra-articular injection of hyaluronic acid sodium salt, Synvisc-One (TRB Chemedica Ltd.)
| Study group | Role | What they receive |
|---|---|---|
| Autologous Mesenchymal Stem Cells Treatment (MSCs) | Experimental | The MSCs treatment group patients will receive an intra-articular injection of a mesenchymal stem cell (MSCs) suspension in the affected knee.
The treatment will be carried out after the patient has received a blood test and clinically evaluated at T0.
T0: Beginning of the study, blood test and bone marrow aspiration. T30: Intra-articular injection of MSCs T44: Adverse events follow up 2 weeks after intra-articular injection (by phone) Receives: Biological: Autologous Mesenchymal Stem Cells Treatment (MSCs) |
| Hyaluronic acid (HA) | Active comparator | The patient will be given a single intra-articular injection of hyaluronic acid sodium salt, Synvisc-One (TRB Chemedica Ltd.) The hyaluronic acid will be purchased for the patient from the manufacturer or from the pharmacy of the hospital.The intra-articular injection will be carried out after the patient has received a clinical evaluation at T0.
T0: Beginning of the study T30: Intra-articular injection of Synvisc-One (HA) T44: Adverse events follow up 2 weeks after intra-articular injection (by phone) Receives: Drug: Hyaluronic acid (HA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society Score
Clinical Questionnaire Assessment Tool. Score 80-100 = Excellent, Score 70-79 = Good, Score 60-69 = Fair, Score below 60 = Poor
Measured: One year
Knee Society Function Score
Clinical Questionnaire Assessment Tool. Score from 100 to -20. The higher the score, the better the knee function outcome.
Measured: One year
Magnetic resonance image (MRI) and X-ray assessment
Radiological assessment of the knee joint
Measured: One year
Secondary outcomes (3)
Health related quality of life score (HRQoL) - SF36
Questionnaire Assessment
Measured: One year
Western Ontario and McMaster Osteoarthritis Index (WOMAC)
Questionnaire Assessment
Measured: One year
Visual Analogic Scale (VAS) pain evaluation
Questionnaire Assessment
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start31 Jan 2015
- Primary completion30 Jan 2019
- Study completion28 Feb 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.
- More trials run by Chinese University of Hong KongThe 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ho Ki Wai, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326985
- Sponsor's protocol ID
- OA MSC Study protocol v 1.4
- Acronym
- MSC
- Status last verified
- May 2020
- First submitted
- 27 Mar 2020
- Last updated
- 18 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Clinical Trial to Evaluate the Efficacy of Intra-articular Injections of Mesenchymal Stem Cells Versus Hyaluronic Acid in Patients Affected by Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT04326985
- Acronym / sponsor ID
- MSC / OA MSC Study protocol v 1.4
- Conditions
- Osteoarthritis, Knee
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 31 Jan 2015 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 30 Mar 2020 (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.
The purpose of this study is to evaluate the therapeutic effect of adult autologous mesenchymal stem cells (abbreviated as MSCs) in patients with osteoarthritic knee and compare to intra articular injection of Synvisc-One.
Detailed description
Study Participants:
This study will involve patients affected by osteoarthritis who comply with the inclusion and exclusion criteria. 30 patients, between the age of 18 and <65, will be enrolled in the study and randomized into three groups to receive either an injection of MSCs, hyaluronic acid (HA) or no injection.
Type of Study: This is a randomized control study.
Treatment method: Each patient will randomly be assigned to one of the following treatment groups:
Group A) Mesenchymal stem cells (MSCs) Group B) Hyaluronic acid (HA) Group C) No injection
Treatment:
Group A) Autologous Mesenchymal Stem Cells Treatment (MSCs) The MSCs treatment group patients will receive an intra-articular injection of a mesenchymal stem cell (MSCs) suspension in the affected knee.
The treatment will be carried out after the patient has received a blood test and clinically evaluated at T0.
T0: Beginning of the study, blood test and bone marrow aspiration. T30: Intra-articular injection of MSCs T44: Adverse events follow up 2 weeks after intra-articular injection (by phone)
Group B) Hyaluronic acid (HA) The patient will be given a single intra-articular injection of hyaluronic acid sodium salt, Synvisc-One (TRB Chemedica Ltd.) The hyaluronic acid will be purchased for the patient from the manufacturer or from the pharmacy of the hospital.
The intra-articular injection will be carried out after the patient has received a clinical evaluation at T0.
T0: Beginning of the study T30: Intra-articular injection of Synvisc-One (HA) T44: Adverse events follow up 2 weeks after intra-articular injection (by phone)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Autologous Mesenchymal Stem Cells Treatment (MSCs) | Experimental | Biological: Autologous Mesenchymal Stem Cells Treatment (MSCs)The MSCs treatment group patients will receive an intra-articular injection of a mesenchymal stem cell (MSCs) suspension in the affected knee. The treatment will be carried out after the patient has received a blood test and clinically evaluated at T0. T0: Beginning of the study, blood test and bone marrow aspiration. T30: Intra-articular injection of MSCs T44: Adverse events follow up 2 weeks after intra-articular injection (by phone) |
| Hyaluronic acid (HA) | Active comparator | Drug: Hyaluronic acid (HA)The patient will be given a single intra-articular injection of hyaluronic acid sodium salt, Synvisc-One (TRB Chemedica Ltd.) The hyaluronic acid will be purchased for the patient from the manufacturer or from the pharmacy of the hospital.The intra-articular injection will be carried out after the patient has received a clinical evaluation at T0. T0: Beginning of the study T30: Intra-articular injection of Synvisc-One (HA) T44: Adverse events follow up 2 weeks after intra-articular injection (by phone) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female subjects aged between 18 and < 65
- Radiological evidence of osteoarthritis with Kellgren and Lawrence grade 2 and 3
- Patients on a pain level equal to or higher than 5 on a VAS scale of 10
Key exclusion criteria (7 listed)
- Previous cases of alcoholism or drug abuse
- Pregnancy and breast-feeding
- Serious pathologies such as carcinoma or autoimmune disease
- Hypersensitivity toward Hyaluorinc Acid
- Undergoing steroid-based systemic therapy or interrupted since less than 1 month
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 |
|---|---|---|
| Autologous Mesenchymal Stem Cells Treatment (MSCs)The MSCs treatment group patients will receive an intra-articular injection of a mesenchymal stem cell (MSCs) suspension in the affected knee. | Biological | Autologous Mesenchymal Stem Cells Treatment (MSCs) |
| Hyaluronic acid (HA)The HA group patient will be given a single intra-articular injection of hyaluronic acid sodium salt, Synvisc-One (TRB Chemedica Ltd.) | Drug | Hyaluronic acid (HA) |
Primary outcome
Knee Society Score
Time frame: One year
Clinical Questionnaire Assessment Tool. Score 80-100 = Excellent, Score 70-79 = Good, Score 60-69 = Fair, Score below 60 = Poor
Knee Society Function Score
Time frame: One year
Clinical Questionnaire Assessment Tool. Score from 100 to -20. The higher the score, the better the knee function outcome.
Magnetic resonance image (MRI) and X-ray assessment
Time frame: One year
Radiological assessment of the knee joint
3 secondary outcomes
Health related quality of life score (HRQoL) - SF36
Time frame: One year
Western Ontario and McMaster Osteoarthritis Index (WOMAC)
Time frame: One year
Visual Analogic Scale (VAS) pain evaluation
Time frame: One year
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 18 May 2020.
- Individual participant dataSharing planned: Undecided
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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 Early Phase 1 study testing Autologous Mesenchymal Stem Cells Treatment (MSCs) and Hyaluronic acid (HA) in people with Osteoarthritis, Knee, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 7 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 18 May 2020. 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 Hong Kong. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Knee Society Score (time frame: One year). The study lists 3 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 18 May 2020.