RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-05-26

Study Completion:2024-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04368806

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Hugh Lee

CONTACT

301-540-2600

hughlee@kcrnresearch.com

Christine Lee

CONTACT

301-540-2600

christinelee@kcrnresearch.com

Study Locations (Sites)

TriWest Research Associates

El Cajon, California, 92020

United States

BioSolutions Clinical Research Center

La Mesa, California, 91942

United States

Neurovations Research

Napa, California, 94558

United States

Newport Therapeutics

Newport Beach, California, 92660

United States

Source Healthcare

Santa Monica, California, 90403

United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2021-05-26

Study Completion Date2024-12-30

Study Record Updates

Study Start Date2021-05-26

Study Completion Date2024-12-30

Terms related to this study

Additional Relevant MeSH Terms

Osteoarthritis, Knee