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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 ≥ 50 mm out of 100 mm on VAS (Visual Analog Scale) at Screening and Baseline.
  • - Subject who has radiographic evidence of grade 3 osteoarthritis in one knee and grade 1 or 2 in the other 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 who has any of following clinically significant disease or has a medical history of past.
  • - Uncontrolled comorbid disease under treatment.
  • - Kidney diseases (glomerulonephritis, chronic renal failure, etc.) - Liver diseases (acute and chronic liver diseases including fatty liver, liver cirrhosis, etc.) - Endocrine diseases (hypothyroidism/hyperthyroidism, thyroiditis, diabetes insipidus, Cushing's disease, etc.) - 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 a history of cancer or is diagnosed with cancer and currently receiving cancer treatment.
  • - 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 12 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 the principal investigator considers inappropriate for the study due to any other reasons than those listed above

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04368806
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2/Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Nature Cell Co. Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Osteoarthritis, Knee
Additional Details

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)

Arms & Interventions

Arms

Experimental: JointStem

Autologous Adipose tissue derived Mesenchymal Stem Cells(AdMSC)

Placebo Comparator: Placebo

Normal Saline with Autologous Serum

Interventions

Drug: - JointStem

Autologous Adipose tissue derived Mesenchymal Stem Cells (AdMSC)

Other: - Placebo Control

Normal Saline with autologous Serum

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

TriWest Research Associates, El Cajon, California

Status

Recruiting

Address

TriWest Research Associates

El Cajon, California, 92020

Site Contact

Louis J. Levy Jr., M.D.

[email protected]

619-334-4735

BioSolutions Clinical Research Center, La Mesa, California

Status

Recruiting

Address

BioSolutions Clinical Research Center

La Mesa, California, 91942

Site Contact

Peter B. Hanson, M.D.

[email protected]

619-637-0770

Source Healthcare, Santa Monica, California

Status

Recruiting

Address

Source Healthcare

Santa Monica, California, 90403

Site Contact

Timothy T. Davis, M.D.

[email protected]

310-574-2777

Washington, District of Columbia

Status

Recruiting

Address

International Spine Pain, and Performance Center

Washington, District of Columbia, 20006

Site Contact

Mehul Desai, M.D., M.P.H.

[email protected]

202-851-6845

Rothman Orthopaedic Institute, Egg Harbor Township, New Jersey

Status

Not yet recruiting

Address

Rothman Orthopaedic Institute

Egg Harbor Township, New Jersey, 08234

Site Contact

Bradford S. Tucker, M.D.

[email protected]

844-438-1354

Hospital for Special Surgery, New York, New York

Status

Not yet recruiting

Address

Hospital for Special Surgery

New York, New York, 10021

Site Contact

Sabrina M. Strickland, M.D.

[email protected]

212-606-1000