A Phase 2b/3a Study to Evaluate the Efficacy and Safety of JointStem in Patients Diagnosed as Knee Osteoarthritis

November 7, 2023 updated by: Nature Cell Co. Ltd.

A 48-Weeks, Phase 2b/3a, Double-Blind, Randomized, Placebo Controlled, Multi-center, Superiority Study to Evaluate the Efficacy and Safety of JointStem, Autologous Adipose Tissue Derived Mesenchymal Stem Cells in Patients Diagnosed as Knee Osteoarthritis

This study is a double-blind, randomized, placebo controlled, multi-center, superiority study to evaluate the efficacy and safety of JointStem, autologous adipose tissue derived mesenchymal stem cells (AdMSC), in patients diagnosed as knee osteoarthritis. Following a 2-week screening period, approximately 140 subjects will be randomly assigned into one of the following two arms in a 1:1 ratio (1 JointStem : 1 Placebo). After each subject completes 48-Weeks visit (Visit 8) and the data management team confirms all individual data have no issue, the individual database will be locked and the blinding will be open for the statistical analysis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Study Procedures:

  • Visit 1 (Week -7) - Screening
  • Visit 2 (Week -5) - Baseline and Randomization (Lipoaspiration)
  • Visit 3 (Week 0) - Treatment (Intra-articular injection)
  • Visit 4 (Week 4) - 4 weeks follow-up
  • Visit 5 (Week 12) - 12 weeks follow-up
  • Visit 6 (Week 24) - 24 weeks follow-up
  • Visit 7 (Week 36) - 36 weeks follow-up
  • Visit 8 (Week 48) - 48 weeks follow-up (End of Study)

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • El Cajon, California, United States, 92020
        • Recruiting
        • Triwest Research Associates
        • Contact:
          • Arthur R. Mabaquiao, M.D.
          • Phone Number: 619-334-4735
        • Contact:
      • La Mesa, California, United States, 91942
      • Napa, California, United States, 94558
      • Newport Beach, California, United States, 92660
        • Recruiting
        • Newport Therapeutics
        • Contact:
          • Richard Paicius, M.D.
          • Phone Number: 949-644-5800
        • Contact:
      • Santa Monica, California, United States, 90403

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subject who had osteoarthritis of knee diagnosed (according to the clinical and American College of Rheumatology Criteria)
  • Subject who has ≥ 34 on WOMAC function score at Screening and Baseline
  • Subject who has knee pain ≥ 70 mm for one knee out of 100 mm on VAS (Visual Analog Scale) at Screening and Baseline
  • Subject who has radiographic evidence of grade 3 osteoarthritis in the study knee based on the Kellgren and Lawrence radiographic criteria.
  • Subjects whose knee pain persists for at least 12 weeks (about 3 months) prior to screening and does not improve symptoms with non-operative treatment options
  • 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 is willing and able to give written informed consent for participation in the study

Exclusion Criteria:

  • Subject who has Body Mass Index (BMI) > 35 kg/m2
  • Subject judged by the investigator to have a history of clinically significant disease
  • Subject who has any of following clinically significant disease
  • Autoimmune diseases
  • Paget's disease, ochronosis, acromegaly, hemochromatosis, or Wilson's disease
  • Genetic diseases (hyperkinesia, collagen gene abnormality, etc.)
  • Inflammatory joint disorders (e.g. rheumatoid inflammation)
  • Infectious joint disorders (e.g. septic arthritis)
  • Other joint disorders (e.g. gout, recurrent pseudogout, articular fracture, primary osteochondrosis, villonodular synovitis)
  • Subject who has any history of cancer or currently receiving treatment for a current cancer diagnosis
  • Subject who is positive in pathogenic test (HIV, viral hepatitis, or syphilis)
  • Subject who has heart diseases (myocardial infarction, coronary artery bypass graft surgery, arrhythmia, or other serious heart diseases) or has history of heart diseases within 6 months prior to Screening
  • Subject who have received any intra-articular therapy in any joint within 6 months prior to Screening, or surgery on the relevant knee including articular endoscopic procedures within 6 months prior to Screening
  • Subject who has history of prolotherapy, or platelet rich plasma injection within 6 months prior to Screening
  • Subject who have received long-acting hyaluronic acid injection (e.g. Synvisc-One®, etc.) within 6 months prior to Screening
  • Subject who has history of stem cell therapy

  • Subject who have significant lab abnormalities for the following parameters (If the value is within 10% of the listed laboratory exclusion criterion value and the value is considered not to be clinically significant by the investigator, the subject can be considered for enrollment):

    • Serum ALT and AST > 2 x upper limit of normal
    • Serum creatinine out of normal range
    • PT/INR out of normal range
    • Hemoglobin < 10 g/dL for female subject and hemoglobin < 11 g/dL for male subject
    • Platelets out of normal range
  • Subject for whom the investigator judges the lipoaspiration can cause any problem
  • Subject who has history of local anesthetic allergy
  • Subject who has taken anti-inflammatory drugs (prescription and non-prescription NSAIDs), symptomatic slow acting drugs (glucosamine, chondroitin sulfate, diacerhein etc.), or oral steroids (prednisone etc.) within 14 days prior to Screening (however, those who undergo a 14-day wash-out period can participate.)
  • Subject who is an active drug/alcohol abuser
  • Pregnant or breast-feeding women, or women or men who are not using appropriate method of contraception (appropriate method includes hormones, bilateral tubal ligation, and barrier method with spermicide, and intra-uterine device for women and vasectomy and barrier method with spermicide for men; subjects should agree to use appropriate method)
  • Subject who is enrolled in any other clinical trials within 3 months from Screening
  • Subject who received the COVID-19 vaccines within 1 week from Visit 2 (Lipoaspiration, baseline)
  • Subject who the principal investigator considers inappropriate for the study due to any other reasons than those listed above

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: JointStem
Autologous Adipose tissue derived Mesenchymal Stem Cells(AdMSC)
Drug: JointStem
Autologous Adipose tissue derived Mesenchymal Stem Cells (AdMSC)
Placebo Comparator: Placebo
Normal Saline with Autologous Serum
Other: Placebo Control
Normal Saline with autologous Serum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Ontario and McMaster Universities Arthritis Index (WOMAC) function Score
Time Frame: Baseline and Week 48
Change from baseline in WOMAC function score at Week 48
Baseline and Week 48
Visual Analog Scale (VAS) score
Time Frame: Baseline and Week 48
Change from baseline on Visual Analog Scale (VAS) score at Week 48
Baseline and Week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Ontario and McMaster Universities Arthritis Index (WOMAC) subscale (Function)
Time Frame: Week 12, 24 and 36
Change from baseline in WOMAC subscale (Function) score at Week 12, 24, and 36
Week 12, 24 and 36
Western Ontario and McMaster Universities Arthritis Index (WOMAC) subscale (Pain)
Time Frame: Week 12, 24, 36, and 48
Change from baseline in WOMAC subscale (Pain) score at Week 12, 24, 36, and 48
Week 12, 24, 36, and 48
Total Western Ontario and McMaster Universities Arthritis Index (WOMAC) score
Time Frame: Week 12, 24, 36, and 48
Change from baseline in total WOMAC score at Week 12, 24, 36, and 48
Week 12, 24, 36, and 48
Visual Analog Scale (VAS) score
Time Frame: Week 12, 24 and 36
Change from baseline in VAS score at Week 12, 24 and 36
Week 12, 24 and 36
International Knee Documentation Committee (IKDC) score
Time Frame: Week 12, 24, 36, and 48
Change from baseline in IKDC score at Week 12, 24, 36, and 48
Week 12, 24, 36, and 48
36-Item Short Form health survey questionnaires (SF-36) score
Time Frame: Week12, 24, 36, and 48
Change from baseline in SF-36 score at Week 12, 24, 36, and 48
Week12, 24, 36, and 48
Kellgren-Lawrence grade
Time Frame: Week 48
Change from baseline in Kellgren-Lawrence grade of knee osteoarthritis determined by X-ray at Week 48
Week 48
Number and amount of rescue medication use
Time Frame: Week 12, 24, 36, and 48
The number and amount of rescue medication use at Week 12, 24, 36, and 48
Week 12, 24, 36, and 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nature Cell Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2021

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

April 21, 2020

First Submitted That Met QC Criteria

April 27, 2020

First Posted (Actual)

April 30, 2020

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JS-OAP3-US01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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