Knee OsteoarthritisNCT03357575
The Comparison of Efficacy and Safety of the Mesenchymal Stem Cells From Adipose and Hyaluronic Acid
A study testing Mesenchymal Stem Cells from adipose and Hyaluronic Acid in people with Knee Osteoarthritis, run by Peking University People's Hospital.
Trial summary
The aim of this study was to evaluate the efficacy and safety of Mesenchymal Stem Cells (MSCs) from adipose anticular injection in comparison with hyaluronic acid anticular injection in the treatment of human knee osteoarthritis(OA). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Mesenchymal Stem Cells from adipose and Hyaluronic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 1 Dec 2020
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- K / L score of 2-3;
- chronic knee pain;
- no local or systemic infection;
- without obvious contraindication of the joint puncture from hematology and biochemical tests;
- informed consent.
Who cannot join
- older than 75 years old or less than 18 years old, or without full capacity for civil conduct;
- HIV, hepatitis virus or syphilis virus infection or their serology is positive;
- BMI index is greater than 30;
- congenital or acquired knee deformity;
- pregnant or lactating women;
- tumor patients;
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- immunodeficiency patients;
- intra-articular drug injection history within 3 months;
- participating in other clinical trials;
- other patients who researchers believe are not eligible for inclusion such as suffering from other concomitant diseases.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Comparison of Efficacy and Safety of the Mesenchymal Stem Cells From Adipose and Hyaluronic Acid in the Treatment of Adult Knee Osteoarthritis
The aim of this study was to evaluate the efficacy and safety of Mesenchymal Stem Cells (MSCs) from adipose anticular injection in comparison with hyaluronic acid anticular injection in the treatment of human knee osteoarthritis(OA).
Read the detailed description
This is a single-centre, quadruple blined, randomized controlled clinical trials with a total of 14 knee osteoarthrits patients as participants, who will be randomly assigned into experiment group or compare group.Participants in experiment group will receive the treatment of MSCs from adipose anticular injection, while participants in compare group will receive hyaluronic acid. Unexplained local and systemic symptoms as well as visual analog scale pain score, WesternOntario McMasterUniversities (WOMAC) Osteoarthritis Index scorewill be assessed at baseline and 2 years after the injection.
- Conditions
- Knee Osteoarthritis
- Being tested
- Mesenchymal Stem Cells from adipose, Hyaluronic Acid
- Keywords
- Knee Osteoarthritis, adipose, 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.
Mesenchymal Stem Cells from adiposeBiological
inject mesenchymal Stem Cells from adipose
Hyaluronic AcidBiological
inject hyaluronic acid
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal Stem Cells from adipose | Experimental | Mesenchymal Stem Cells from adipose will be injected. Receives: Biological: Mesenchymal Stem Cells from adipose |
| hyaluronic acid | Active comparator | Hyaluronic acid will be injectied. Receives: Biological: Hyaluronic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unexplained local and systemic symptoms or death
The severity of AE must be recorded and graded according to the CTCAE criteria, and its relationship to therapy must be assessed according to the following definition:①not related: there is evidence that the cause of adverse events is not due to intra-articular injection therapy (such as previous conditions, potential diseases, concurrent diseases); ②related: AE and intra-articular injection are time-related and it is known or suspected that intra-articular injection of drugs can cause the AE; ③it can't be assessed.
Measured: 2 years
Secondary outcomes (2)
VAS score
VAS score decrease 3 points or more
Measured: 2 years
WOMAC score
two or more terms of WOMAC score have improvement.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start1 Jan 2018 (estimated)
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yangziyi, Peking University People's Hospital
- Investigators
- Ziyi Yang, Principal investigator, arthritis clinic and research center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357575
- Sponsor's protocol ID
- PUPH20170912
- Status last verified
- Nov 2017
- First submitted
- 25 Nov 2017
- Last updated
- 30 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Efficacy and Safety of the Mesenchymal Stem Cells From Adipose and Hyaluronic Acid in the Treatment of Adult Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03357575
- Acronym / sponsor ID
- PUPH20170912
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, adipose, mesenchymal stem cells
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 30 Nov 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.
The aim of this study was to evaluate the efficacy and safety of Mesenchymal Stem Cells (MSCs) from adipose anticular injection in comparison with hyaluronic acid anticular injection in the treatment of human knee osteoarthritis(OA).
Detailed description
This is a single-centre, quadruple blined, randomized controlled clinical trials with a total of 14 knee osteoarthrits patients as participants, who will be randomly assigned into experiment group or compare group.Participants in experiment group will receive the treatment of MSCs from adipose anticular injection, while participants in compare group will receive hyaluronic acid. Unexplained local and systemic symptoms as well as visual analog scale pain score, WesternOntario McMasterUniversities (WOMAC) Osteoarthritis Index scorewill be assessed at baseline and 2 years after the injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal Stem Cells from adipose | Experimental | Biological: Mesenchymal Stem Cells from adiposeMesenchymal Stem Cells from adipose will be injected. |
| hyaluronic acid | Active comparator | Biological: Hyaluronic AcidHyaluronic acid will be injectied. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- K / L score of 2-3;
- chronic knee pain;
- no local or systemic infection;
- without obvious contraindication of the joint puncture from hematology and biochemical tests;
- informed consent.
Key exclusion criteria (10 listed)
- older than 75 years old or less than 18 years old, or without full capacity for civil conduct;
- HIV, hepatitis virus or syphilis virus infection or their serology is positive;
- BMI index is greater than 30;
- congenital or acquired knee deformity;
- pregnant or lactating women;
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 |
|---|---|---|
| Mesenchymal Stem Cells from adiposeinject mesenchymal Stem Cells from adipose | Biological | Mesenchymal Stem Cells from adipose |
| Hyaluronic Acidinject hyaluronic acid | Biological | hyaluronic acid |
Primary outcome
Unexplained local and systemic symptoms or death
Time frame: 2 years
The severity of AE must be recorded and graded according to the CTCAE criteria, and its relationship to therapy must be assessed according to the following definition:①not related: there is evidence that the cause of adverse events is not due to intra-articular injection therapy (such as previous conditions, potential diseases, concurrent diseases); ②related: AE and intra-articular injection are time-related and it is known or suspected that intra-articular injection of drugs can cause the AE; ③it can't be assessed.
2 secondary outcomes
VAS score
Time frame: 2 years
WOMAC score
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- Individual participant dataSharing planned: No
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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.
Ziyi Yang principal investigator
arthritis clinic and research center
Questions about this trial
What is this clinical trial studying?
A study testing Mesenchymal Stem Cells from adipose and Hyaluronic Acid in people with Knee Osteoarthritis, run by Peking University People's Hospital.
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 10 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 30 Nov 2017. 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 Ziyi Yang, MD (18810335110, bjmuyangziyi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unexplained local and systemic symptoms or death (time frame: 2 years). 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 30 Nov 2017.