Investigator Initiated Trial to Evaluate Cartilage Regeneration by Arthroscopy After JOINTSTEM Administration

September 27, 2022 updated by: R-Bio

Investigator Initiated Trial to Evaluate Cartilage Regeneration by Arthroscopy in Patients With K-L Grade III Knee Osteoarthritis After JOINTSTEM Administration

The purpose of this study is to confirm cartilage regeneration through arthroscopy after a single administration of autologous Adipose Tissue derived Mesenchymal stem cells(JOINTSTEM) in patients with degenerative arthritis of K-L grade 3

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

JOINTSTEM is injectables for an OA treatment that uses autologous adipose-derived mesenchymal stem cells. As it does not use allogenic tissues and is cultured without additional genetic modification, it is classified as 'autologous cell therapy' and is completely free of immunologic rejection.

It primarily aims to regenerate cartilage. The intra-articular injection of JOINTSTEM is expected to stimulate the regeneration of cartilage, and to innovatively improve joint function with cartilage regeneration.

The subjects of this therapy were patients with K&L grade 3 aged 20 or older.

This study is a double-blind, randomized, placebo controlled study with two arms to evaluate JOINTSTEM as a treatment for subjects with osteoarthritis. Following a 2-week screening period, approximately 21 patients will be randomly assigned into one of the following two arms in a 2:1 ratio (2 JointStem : 1 placebo control). After each patient completes 12-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.

Study Type

Interventional

Enrollment (Anticipated)

21

Phase

  • Not Applicable

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

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 20 and older, male and female
  2. Patients must consent in writing to participate in the study by signing and dating an informed consent document
  3. Diagnosis of degenerative arthritis of class 1-3 by ACR(American College of Rheumatology Criteria) Global functional criteria
  4. Diagnosis of Kellgren and Lawrence grade 3 by radiographic criteria

  5. Patients suitable for one of three conditions of 'diagnostic criteria for osteoarthritis of knee' based on ACR guideline

    • clinical and inspectional opinion
    • clinical and radiographic opinion
    • clinical opinion
  6. Patients who has joint pain ≥ 50mm on 100mm VAS (Visual Analog Scale) at Screening
  7. Patient who has WOMAC score ≥ 1000 at Screening
  8. No improvement with persisting knee pain at least for 12 weeks (3 months) by nonoperational therapy before Screening

Exclusion Criteria:

  1. Patients who have pregnancy plans within this trial period or childbearing age patients who do not agree to maintain contraception status through appropriate contraception methods

    • Appropriate contraception method: Use of condom, contraceptive sponges, foam, diaphragm, intrauterine device etc.
    • Periodic abstinence(e.g. methods of predicting ovulation) and moderation are not considered as appropriate contraception method.
    • Not allowed to use hormonal contraceptives
    • Childbearing age female patients, exclude menopausal female (amenorrhea for more than 24 months after the last menstruation) or female who has no possibility of pregnency by surgical sterilization operation, can participate in this study only determined negative in pregnancy test
  2. Pregnant women or lactating mothers
  3. Patients with Body Mass Index (BMI) > 35
  4. Patients with positive human immunodeficiency (HIV), hepatitis B (HBV), hepatitis C (HCV), syphilis at screening indicative of current of pass infection

  5. Patients with other disease including

    • Septic arthritis, Rheumatoid or Inflammatory joint disease, Gout, Reccurent pseudogout, Paget disease, Articular fractures, Ochronosis, Acromegaly, Hemochromatosis, Wilson's disease,Osteochondromatosis, Hereditary disorder, Genetic disorder of collagen
  6. Patients who are diagnosed with malignant tumor in the past or present

  7. Patients who have clinically significant diseases including

    • Cardiac disorder (Myocardial infarction, Coronary artery bypass graft, Arrhythmia and other severe Cardiac disorder etc.)
    • Resistant hypertension (systolic blood pressure > 160mmHg or diastolic pressure > 100mmHg at Screening)
    • Kidney disease (Chronic renal failure, Glomerulonephritis etc.)
    • Liver disease (Hepatocirrhosis, Fatty liver, acute or chronic liver disease etc.)
    • Endocrinopathy (Thyroiditis, Diabetes insipidus, Cushing disease etc.)
  8. Patients who have significant lab abnormalities
  9. Patients who have severe pain in other areas that can affect the judgement of knee joint symptom
  10. Patients who underwent any arthroscopic surgery on the injection site within 6 months of the screening visit date, or scheduled to perform any surgery during the clinical trial period
  11. Patients who received any drug by intra-articular injection(hyaluronic acid or steroid etc.) for treatment within 6 months prior to Screening
  12. Patients who experienced as stem cell therapy or blood product injection(PRP, Prolo therapy etc.)

  13. Patients who received treatment within 14 days prior to Screening including(But, patients who had wash-out-period can participate in this study)

    • Take medicines including composition of Glucosamine, Chondretin sulphate and Diacerhein etc.
    • Take phytotherapeutic agent or Chinese medicine for osteoarthritis
    • Take antiinflammatory analgesic drug, NSAIDs (prescription/nonprescription pharmaceuticals) etc. (Patients who have 3 days of wash-out-period after they took acetaminophen can participate in the study)
    • Take oral steroids
  14. Patients with penicillin hypersensitivity reactions
  15. Patients with skin diseases or infections in the area of the injection site
  16. Patients who have abnormal flail over grade 2 flail knee test of anterior to posterior and varus/valgus lesion at physical examination
  17. Patients who have difficulty in taking MRI because of metal materials (cardiac pacemaker or clip of cerebral artery etc.) in their body or claustrophobia -but, patients with metal materials that are not affected by magnetic field can participate in this study
  18. Patients who have difficulty in liposuction or local anesthesia
  19. Patients who have alcohol, drug abuse history
  20. Patients who have severe neurologic and psychiatric disorders that affect clinical trials
  21. Patients who had participated in other clinical trials within 12 weeks prior to this study
  22. Patients who the principal investigator considers inappropriate for the clinical trial 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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Saline
saline
Drug: Saline
saline, 1 time injection under ultrasonic guided
Experimental: JOINTSTEM
Autologous Adipose Tissue derived MSCs
Biological: JOINTSTEM
JOINTSTEM Autologous Adipose Tissue derived MSCs 1x10^8cells/(saline), 1 time injection under ultrasonic guided
Other Names:
  • Autologous Adipose Tissue derived MSCs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arthroscopy
Time Frame: 48 Weeks
Change of damaged cartilage defects after 48 weeks from IP administration, compared to Baseline (Experimental group vs Control group)
48 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WOMAC total score
Time Frame: 12 weeks, 24 weeks, 48 weeks
Change of Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) total scores from baseline (Experimental group vs Control group)
12 weeks, 24 weeks, 48 weeks
WOMAC subscale score
Time Frame: 12 weeks, 24 weeks, 48 weeks
Change of Western Ontario and McMaster Universities (WOMAC) subscale score (3 sub-scales: Pain, stiffness, and physical function of the knee) from baseline (Experimental group vs Control group)
12 weeks, 24 weeks, 48 weeks
VAS score
Time Frame: 12 weeks, 24 weeks, 48 weeks
Change of Visual Analog Scale (VAS) from baseline (Experimental group vs Control group) Pain of knee will be measured by the 100mm VAS Score range is from 0mm(no pain) to 100mm(severe pain) Pain of knee will be measured by the 100mm Visual Analog Scale (VAS)
12 weeks, 24 weeks, 48 weeks
RAND-36
Time Frame: 12 weeks, 24 weeks, 48 weeks
Change of The RAND-36 Measure of Health-Related Quality of Life (RAND-36) score from baseline (Experimental group vs Control group) Scoring the RAND 36-Item Health Survey is a two-step process. First, precoded numeric values are recoded per the scoring key given in Table 1. Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores.
12 weeks, 24 weeks, 48 weeks
IKDC
Time Frame: 12 weeks, 24 weeks, 48 weeks
Change of International Knee Documentation Committee (IKDC) score from baseline (Experimental group vs Control group) The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
12 weeks, 24 weeks, 48 weeks
Biopsy
Time Frame: 48 Weeks
Change of Biopsy from baseline (Experimental group vs Control group)
48 Weeks
Use of rescue medication
Time Frame: 4 Weeks, 12 Weeks, 24 Weeks, 48 Weeks
Frequency and total amount of rescue medication administration will be measured.
4 Weeks, 12 Weeks, 24 Weeks, 48 Weeks
Kellgren-Lawrence grade
Time Frame: 24 Weeks, 48 Weeks
Change from baseline in Kellgren-Lawrence grade of knee osteoarthritis determined by X-ray at Week 48
24 Weeks, 48 Weeks

Collaborators and Investigators

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

Sponsor

R-Bio

Investigators

  • Principal Investigator: CHANGMIN LEE, M.D.,Ph.D., Bethesda Hospital

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 (Anticipated)

July 1, 2023

Primary Completion (Anticipated)

August 1, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

March 24, 2021

First Submitted That Met QC Criteria

March 26, 2021

First Posted (Actual)

March 29, 2021

Study Record Updates

Last Update Posted (Actual)

September 28, 2022

Last Update Submitted That Met QC Criteria

September 27, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BS-JS-IIT1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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