OsteoarthritisPhase 2NCT03028428
Intra-articular Injection of MSCs in Treatment of Knee OA
A Phase 2 study testing Placenta Derived Mesenchymal Stem Cell and Sodium Hyaluronate in people with Osteoarthritis and Stem Cells, run by Affiliated Hospital of Jiangsu University.
Trial summary
In this study, researchers want to determine the safety of MSCs that a patient can tolerate without causing side effects. Moreover researchers will also be looking at the function of the knee over time, which may give them some insight on the usefulness of MSCs as a treatment option. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis, Stem Cells, MSC
- What is being tested?
- Placenta Derived Mesenchymal Stem Cell and Sodium Hyaluronate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2019
- Phase
- Phase 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 40-75 years of age with symptomatic moderate to severe (Kellgren-Lawrence III or IV) primary osteoarthritis of the knee
- Idiopathic or secondary osteoarthritis of the knee with grade 2,3, or 4 radiographic severity, as defined by the modified Kellgren-Lawrence classification
- No history of prior intra-articular cortisone, hyaluronic acid, or platelet-rich plasma injection within the previous six months
- No history of prior arthroscopic knee surgery or open knee surgery on the ipsilateral side within the past year
- Adequate bone marrow, liver, and renal functions
- Body weight >40 kg
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- Body Mass Index <40
- Negative for (HIV, HTLV1\&2, Hep A, B, C, syphilis) infection as determined by approved serological testing
- Negative for pregnancy as determined by a serum pregnancy test. Females of childbearing potential will be required to practice abstinence or use an effective form of contraception for 12 months following their MSC injection.
- Ability to provide written informed consent.
Who cannot join
- Patients with clinically unstable knee due to the presence of a complete anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament and/or posterolateral corner tear
- Patients with varus or valgus malalignment >5 degrees as measured by 4 foot standing antero-posterior radiographs
- Patients with a history of a previous subtotal medial or lateral meniscectomy
- Patients with a history of septic arthritis in the affected joint
- Patients with a history of a prior intra-articular knee fracture
- Severe bleeding diathesis
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- Contraindication to bone marrow aspiration and/or biopsy
- Active infection
- Bone marrow failure
- Cytopenia
- Patients who have previously received radiotherapy to the pelvis
- Patients who have been on chemotherapy from within a year of the date of informed
- Patients with positive serological test for (HIV, HTLV1\&2, Hep A, B, C, syphilis)
- Pregnancy or risk of pregnancy (this includes participants that are not willing to practice active contraception for the duration of the study)
- Patients with unforeseen conditions that are deemed unsafe or inappropriate for the study (e.g. patients who are claustrophobic and cannot undergo an MRI) as per the discretion of the principal investigator
About this study
Official title: Clinical Research on Intra-articular Injection of Human Autologous MSCs in Treatment of Knee OA
In this study, researchers want to determine the safety of MSCs that a patient can tolerate without causing side effects. Moreover researchers will also be looking at the function of the knee over time, which may give them some insight on the usefulness of MSCs as a treatment option.
Read the detailed description
Osteoarthritis (OA) is one of the most common forms of arthritis. It is a lasting condition in which the material that cushions the joints, called cartilage, breaks down. This causes the bones to rub against each other, causing inflammation, stiffness, pain and loss of joint movement. Currently, there are few effective treatments available for patients suffering from OA.
Mesenchymal stem cells (MSCs) are cells that have the ability to self-regenerate, which means they have the ability to make copies of themselves and to turn into other kinds of cells (e.g. cartilage cells). Stem cell science shows much promise for the future treatment of osteoarthritis, but much of the research is still in the early stages. In this study, researchers want to determine the safety of MSCs that a patient can tolerate without causing side effects. Moreover researchers will also be looking at the function of the knee over time, which may give them some insight on the usefulness of MSCs as a treatment option.
- Conditions
- Osteoarthritis, Stem Cells, MSC
- Being tested
- Placenta Derived Mesenchymal Stem Cell, Sodium Hyaluronate
- Keywords
- Osteoarthritis, Stem Cell, Knee, Mesenchymal Stem Cell
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placenta Derived Mesenchymal Stem CellBiological
Also called Mesenchymal Stromal Cells (MSCs)
1ml 1*10^7 Placenta Derived Mesenchymal Stem Cell administered into the knee joint once
Sodium HyaluronateDrug
Also called hyaluronate
Sodium hyaluronate administered into the knee joint once
| Study group | Role | What they receive |
|---|---|---|
| Placenta Derived Mesenchymal Stem Cell | Experimental | Placenta Derived Mesenchymal Stem Cell administered into the knee joint once Receives: Biological: Placenta Derived Mesenchymal Stem Cell |
| sodium hyaluronate | Active comparator | Sodium hyaluronate administered into the knee joint once Receives: Drug: Sodium Hyaluronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events
Number of participants with adverse events as measure of safety and tolerability
Measured: 1 Year
Secondary outcomes (4)
radiographic evidence
Number of participants with a change in cartilage thickness of knee OA using MRI
Measured: 1 Year
WOMAC assessment
Number of participants with a change in joint function from baseline WOMAC assessment
Measured: 1 Year
VAS
Number of participants with a change in arthritis pain scores on the visual analogue scale
Measured: 1 Year
SF-36
Number of participants with a change in SF-36
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized, Double Blind, Phase-II Study Assessing the Safety and Efficacy of Intraarticular Ex-vivo Cultured Adult Allogeneic Mesenchymal Stem Cells in Patients with Osteoarthritis of Knee
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Jiangsu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YU TANG, Affiliated Hospital of Jiangsu University
- Investigators
- YU TANG, Dr., Principal investigator, Affiliated Hospital of Jiangsu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028428
- Sponsor's protocol ID
- AHJiangsuU-FSK-MSC-OA
- Status last verified
- Jan 2018
- First submitted
- 20 Jan 2017
- Last updated
- 30 Jan 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research on Intra-articular Injection of Human Autologous MSCs in Treatment of Knee OA
- ClinicalTrials.gov ID
- NCT03028428
- Acronym / sponsor ID
- AHJiangsuU-FSK-MSC-OA
- Conditions
- Osteoarthritis, Stem Cells, MSC
- Keywords
- Osteoarthritis, Stem Cell, Knee, Mesenchymal Stem Cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Jiangsu UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 23 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.
In this study, researchers want to determine the safety of MSCs that a patient can tolerate without causing side effects. Moreover researchers will also be looking at the function of the knee over time, which may give them some insight on the usefulness of MSCs as a treatment option.
Detailed description
Osteoarthritis (OA) is one of the most common forms of arthritis. It is a lasting condition in which the material that cushions the joints, called cartilage, breaks down. This causes the bones to rub against each other, causing inflammation, stiffness, pain and loss of joint movement. Currently, there are few effective treatments available for patients suffering from OA.
Mesenchymal stem cells (MSCs) are cells that have the ability to self-regenerate, which means they have the ability to make copies of themselves and to turn into other kinds of cells (e.g. cartilage cells). Stem cell science shows much promise for the future treatment of osteoarthritis, but much of the research is still in the early stages. In this study, researchers want to determine the safety of MSCs that a patient can tolerate without causing side effects. Moreover researchers will also be looking at the function of the knee over time, which may give them some insight on the usefulness of MSCs as a treatment option.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A Randomized, Double Blind, Phase-II Study Assessing the Safety and Efficacy of Intraarticular Ex-vivo Cultured Adult Allogeneic Mesenchymal Stem Cells in Patients with Osteoarthritis of Knee
| Arm | Type | Receives |
|---|---|---|
| Placenta Derived Mesenchymal Stem Cell | Experimental | Biological: Placenta Derived Mesenchymal Stem CellPlacenta Derived Mesenchymal Stem Cell administered into the knee joint once |
| sodium hyaluronate | Active comparator | Drug: Sodium HyaluronateSodium hyaluronate administered into the knee joint once |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients between 40-75 years of age with symptomatic moderate to severe (Kellgren-Lawrence III or IV) primary osteoarthritis of the knee
- Idiopathic or secondary osteoarthritis of the knee with grade 2,3, or 4 radiographic severity, as defined by the modified Kellgren-Lawrence classification
- No history of prior intra-articular cortisone, hyaluronic acid, or platelet-rich plasma injection within the previous six months
- No history of prior arthroscopic knee surgery or open knee surgery on the ipsilateral side within the past year
- Adequate bone marrow, liver, and renal functions
Key exclusion criteria (15 listed)
- Patients with clinically unstable knee due to the presence of a complete anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament and/or posterolateral corner tear
- Patients with varus or valgus malalignment >5 degrees as measured by 4 foot standing antero-posterior radiographs
- Patients with a history of a previous subtotal medial or lateral meniscectomy
- Patients with a history of septic arthritis in the affected joint
- Patients with a history of a prior intra-articular knee fracture
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 |
|---|---|---|
| Placenta Derived Mesenchymal Stem CellAlso: Mesenchymal Stromal Cells (MSCs)1ml 1*10^7 Placenta Derived Mesenchymal Stem Cell administered into the knee joint once | Biological | Placenta Derived Mesenchymal Stem Cell |
| Sodium HyaluronateAlso: hyaluronateSodium hyaluronate administered into the knee joint once | Drug | sodium hyaluronate |
Primary outcome
adverse events
Time frame: 1 Year
Number of participants with adverse events as measure of safety and tolerability
4 secondary outcomes
radiographic evidence
Time frame: 1 Year
WOMAC assessment
Time frame: 1 Year
VAS
Time frame: 1 Year
SF-36
Time frame: 1 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 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.
YU TANG, Dr. principal investigator
Affiliated Hospital of Jiangsu University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Placenta Derived Mesenchymal Stem Cell and Sodium Hyaluronate in people with Osteoarthritis and Stem Cells, run by Affiliated Hospital of Jiangsu University.
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 10 inclusion and 15 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 Jan 2018. 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.
What does this phase mean?
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?
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?
adverse events (time frame: 1 Year). 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 Jan 2018.