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Osteoarthritis, KneePhase 2NCT02674399

A Phase 2 Study to Evaluate the Efficacy and Safety of JointStem in Treatment of Osteoarthritis

A Phase 2 study testing JointStem and Synvisc-One in people with Osteoarthritis, Knee, run by Nature Cell Co. Ltd. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a double-blind, randomized, controlled study with two arms to evaluate JointStem as a treatment for subjects with osteoarthritis. Following a 2-week screening period, approximately 30 subjects will be randomly assigned into one of the following two arms in a 2:1 ratio (2 JointStem : 1 positive control). Read more about this study

Who is it for?
Ages 22 to 60 years
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
JointStem and Synvisc-One
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
2 sitesUnited States
Study dates
16 Feb 2016to 28 Dec 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 22 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Subject who can give written informed consent
  • Male or female of any race, aged 22-60
  • Subject who had osteoarthritis of knee diagnosed at least six months prior to Screening
  • Subject who has joint pain ≥ 40mm on VAS (Visual Analog Scale) at Screening
  • Subject who has swelling, tenderness and active range of motion ≥ Grade I at Screening
  • Subject who seeks invasive interventions of intra-articular injections
Show all 10Show fewer
  • Subject who is willing to discontinue all pain medications for osteoarthritis except rescue medication (< acetaminophen 3.25 g per day) at least 72 hours prior to screening and throughout the duration of study
  • Subject who has radiographic evidence of grade 3 to 4 osteoarthritis based on the Kellgren and Lawrence radiographic criteria.
  • Female subject who is neither pregnant nor lactating
  • Subject who is able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests, and other study procedures

Who cannot join

  • Subject who has Body Mass Index (BMI) > 35 kg/m2
  • Subject who has unstable knees
  • Subject who took any NSAID within two weeks from Screening
  • Subject who had any intra-articular injection therapy in any joint within 2 months from Screening
  • Subject who has any clinically significant disease, which is judged by the investigator to affect this clinical trial
  • Subject who has inflammatory arthropathy (rheumatoid, psoriatic, or avascular necrosis), and post traumatic or septic arthritis
Show all 26Show fewer
  • Subject who has chondrocalcinosis, Paget's disease, Villonodular synovitis, and other non-OA joint diseases
  • Subject who has HIV/viral hepatitis
  • Subject who had knee surgery or radiation therapy in the affected joint within 6 months from Screening
  • Subject who had CVA attack within 6 months from Screening
  • Subject for whom the investigator judges the liposuction can cause any problem
  • Subject who has significant lab abnormalities
  • Subject who has history of local anesthetic allergy
  • Subject who took immunosuppressants such as Cyclosporin A or azathioprine within 6 weeks from Screening
  • (If a subject uses aspirin or plavix) Subject for whom it is determined that it would not be safe to stop the aspirin/plavix therapy for 2 weeks prior to Visit 2
  • Subject who uses anticoagulants which cannot be stopped or corrected
  • Subject who had oral or intra-muscular corticosteroids within 30 days from Visit 2
  • Subject who had intra-articular corticosteroid injection in any joint within 30 days from Visit 2
  • Subject who had intra-articular hyaluronic acid injection within 30 days from Visit 2
  • Subject who has known hypersensitivity (allergy) to hyaluronan (sodium hyaluronate) preparations or gram positive proteins
  • Subject who has knee joint infections or skin diseases or infections in the area of the injection site
  • Subject who has known systemic bleeding disorders
  • Subject who is an active drug/EtOH abuser
  • Subject who was enrolled in any other clinical trials within 2 months from Screening
  • Subject who the principal investigator considers inappropriate for the study due to any other reasons than those listed above
  • Subject whose MRI scan results at screening do not demonstrate any sign of cartilage damage

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Orthopedic Pain Specialists

    Santa Monica, California, 90404

  • Study site

    Walnut Creek, California, 94598

Other trials in United States

About this study

Official title: A Phase 2, Double-Blind, Randomized, Controlled Study to Evaluate the Efficacy and Safety of JointStem, Autologous Adipose Tissue Derived Mesenchymal Stem Cells, in Treatment of Osteoarthritis

This study is a double-blind, randomized, controlled study with two arms to evaluate JointStem as a treatment for subjects with osteoarthritis. Following a 2-week screening period, approximately 30 subjects will be randomly assigned into one of the following two arms in a 2:1 ratio (2 JointStem : 1 positive control). After each subject completes 6-month visit (Visit 6) and the data management team confirms all data have no issue, the individual database will be locked and the blinding will be open for the statistical analysis.Only subjects who are assigned will be requested to visit the study center for 9-month and 12-month follow-up visits (Visits 7 and 8). To see long-term effects of JointStem, all subjects who complete Visit 6 will be requested to visit the study center at 24-month after the injection.

Being tested
JointStem, Synvisc-One
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JointStemDrug

  • Synvisc-OneDrug

    Also called Active Comparator

Study groups in NCT02674399
Study groupRoleWhat they receive
JointStemExperimentalautologous adipose tissue derived mesenchymal stem cells (AdMSC)
Receives: Drug: JointStem
Synvisc-OneActive comparatorhyaluronic acid
Receives: Drug: Synvisc-One

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline on Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score in JointStem Group

    Comparing the baseline and 6-month WOMAC scores in JointStem group Score range: 0-2,400 A score of 2,400 represents the most severe impairment and 0 represents the least impairment

    Measured: Baseline and 6 months

  2. Change From Baseline on Visual Analog Scale (VAS) in JointStem Group

    Comparing the baseline and 6-month VAS scores in JointStem group Score range: 0-100 A score of 100 represents the most severe pain and 0 represents the least pain.

    Measured: Baseline and 6 months

  3. MRI Improvement Evaluation in JointStem Group

    Comparing the baseline and 6-month MRI improvement values in JointStem group MRI Improvement Evaluation was conducted by an MRI analysis company called 'Qmetrics'. The main radiological features evaluated were bone marrow edema, osteophytes, and cartilage. Certain features, such as the appearance of a new cartilage defect or increase in the size of existing cartilage defects or osteophytes, is generally considered an indication of osteoarthritic progression. Similarly, the diminishing in severity or size of existing abnormalities would generally be considered to be a healing(improving) response.

    Measured: 6 months

Secondary outcomes (13)

  1. Change From Baseline on WOMAC Between JointStem and Positive Control Groups

    Comparing the changes of WOMAC scores between JointStem and positive control groups at 6 months Score range: 0-2,400 A score of 2,400 represents the most severe impairment and 0 represents the least impairment

    Measured: Baseline and 6 months

  2. Change From Baseline on VAS Between JointStem and Positive Control Groups

    Comparing the changes of VAS scores between JointStem and positive control groups at 6 months Score range: 0-100 A score of 100 represents the most severe pain and 0 represents the least pain.

    Measured: Baseline and 6 months

  3. Change From Baseline on Knee Injury & Osteoarthritis Outcome Score (KOOS) Between JointStem and Positive Control Groups

    Comparing the changes of KOOS values between JointStem and positive control groups at 6 months KOOS score = 100 - [{(average score of each item) * 100} / 4 ] Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment

    Measured: Baseline and 6 months

  4. Change From Baseline on Lysholm Knee Scoring Scale Between JointStem and Positive Control Groups

    Comparing the changes of Lysholm Knee Scoring Scales between JointStem and positive control groups at 6 months Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment

    Measured: Baseline and 6 months

  5. Change From Baseline on International Knee Documentation Committee (IKDC) Between JointStem and Positive Control Groups

    Comparing the changes of IKDC scores between JointStem and positive control groups at 6 months IKDC score = {(sum of each item score) / 87} * 100 Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment

    Measured: Baseline and 6 months

  6. Change From Baseline on RAND-36 Score Between JointStem and Positive Control Groups

    Comparing the changes of RAND-36 scores between JointStem and positive control groups at 6 months Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment

    Measured: Baseline and 6 months

  7. Change From Baseline on WOMAC in JointStem Group

    Comparing the baseline and 9-month/12-month WOMAC scores in JointStem group Score range: 0-2,400 A score of 2,400 represents the most severe impairment and 0 represents the least impairment

    Measured: Baseline, 9 months and 12 months

  8. Change From Baseline on VAS in JointStem Group

    Comparing the baseline and 9-month/12-month VAS scores in JointStem group Score range: 0-100 A score of 100 represents the most severe pain and 0 represents the least pain.

    Measured: Baseline, 9 months and 12 months

  9. Comparison of MRI Improvement Evaluation in JointStem Group

    Comparing the baseline and 9-month/12-month MRI improvement values in JointStem group MRI Improvement Evaluation was conducted by an MRI analysis company called 'Qmetrics'. The main radiological features evaluated were bone marrow edema, osteophytes, and cartilage. Certain features, such as the appearance of a new cartilage defect or increase in the size of existing cartilage defects or osteophytes, is generally considered an indication of osteoarthritic progression. Similarly, the diminishing in severity or size of existing abnormalities would generally be considered to be a healing(improving) response.

    Measured: Baseline, 6 months and 12 months

  10. Change of Lysholm Knee Scoring Scale From Baseline at Months 6, 9 and 12

    Comparing the baseline and 6-month/9-month/12-month Lysholm Knee Scoring Scale in JointStem group Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment

    Measured: Baseline, 6 months, 9 months and 12 months

  11. Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group

    Comparing the baseline and 6-month/9-month/12-month KOOS scores in JointStem group KOOS score = 100 - [{(average score of each item) * 100} / 4 ] Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment

    Measured: baseline, 6 month, 9 month, 12 month

  12. Change of IKDC Score From Baseline at Month 6, 9 and 12 for JointStem Group

    Comparing the baseline and 6-month/9-month/12-month IKDC scores in JointStem group IKDC score = {(sum of each item score) / 87} * 100 Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment

    Measured: baseline, 6 month, 9 month, 12 month

  13. Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group

    Comparing the baseline and 6-month/9-month/12-month RAND-36 scores in JointStem group Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment

    Measured: baseline, 6 month, 9 month, 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2016 (estimated)
  2. Study start16 Feb 2016
  3. Primary completion12 Mar 2018
  4. Study completion28 Dec 2018

Resources

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
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02674399
Sponsor's protocol ID
JS-OAP2-US01
Status last verified
Jun 2021
First submitted
2 Feb 2016
Last updated
10 Aug 2021
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JointStem and Synvisc-One in people with Osteoarthritis, Knee, run by Nature Cell Co. Ltd. at 2 sites in United States.

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 26 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 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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 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?

Yes. Results are posted in the registry (first posted 13 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline on Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score in JointStem Group (time frame: Baseline and 6 months). 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?

On the ClinicalTrials.gov record for NCT02674399.

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 10 Aug 2021.

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