Clinical Study of Intra Articular Injection of Catholic MASTER Cell (Bone Marrow Derived Mesenchymal Stem Cell) in Knee Osteoarthritis

NCT04240873 | Unknown Phase 1 DMC

• 1 other identifier: KC19CNSI0469
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

• osteoarthritis
• Osteoarthritis is severe and intractable musculoskeletal disease that eventually leads to joint failure and pain due to inflammation and joint injury.
• OA is one of the most prevalent diseases. The prevalence increases with age, but overuse and trauma can result in OA in young population as well.
• Injured cartilage can not be regenerated spontaneously, untreated injured cartilage eventually leads to osteoarthritis. Surgical treatment may repair the damage but the reparied cartilage may turn out to be fibrocartilage rather than hyaline cartilage.
• Curent treatment
• medical therapy: medication for symptom relief, together with exercise. Medications include NSAIDS visco-supplement.
• surgical therapy: total knee replacement arthroplasty
• to overcome such limitations, cell therapy such as stem cell/ chondrocyte injection is being investigated
• Hypothesis
• Protocol 1) deisgn : Injection of MASTER cell 1X 10\^8 cells/2cc (experimental arm) or 2cc saline (placebo arm) into knee of patients with osteoarthritis 2) outcomes
• primary outcome : safety evaluation(adverse event)
• secondary outcomes : check on 1,2,3,6,9,12 months, atient reported outcome (WOMAC, KOOS, IKDC, pain VAS) 3,12 months SF-36, knee MRI score, serum cytokine, bone turnover marker 12 months x-ray 3) Disease
• osteoarthritis 4\) Subjects
• inclusion : age 20-80yrs, diagnosed with OA according to ACR criteria for knee OA, baseline pain VAS equal or more than 50mm
• exclusion: lower extremities surgery within 6months or planned surgery, concommitant systemic rheumatic diseases that can affect the results of the trial, steroid intraarticular inejction into the index knee within 3months, clinicallly meaningful abnormal lab tests (liver function, kidney function)
• primary outome : compare the number and proportion of of adverse event and lab test abnormalities between the two arms
• secondary outome
• change of 100mm pain VAS
• change of Western Ontario and McMAster Universities Osteoarthritis (WOMAC) pain VAS, IKDC, KOOS total score
• change WOMAC sub scale, IKDC, KOOS
• chagne of KHAQ
• change of MRI indices
• change of x-ray( joins space narrowing)
• change of serum ESR/CRP, CTX-II

Conditions

Osteoarthritis, Knee

Keywords

osteoarthritis; mesenchymal stem cell

Outcome Measures

Primary Outcomes (8)

• adverse event according to CTCAE 5.0, clinically meaningful abnormalites in laboratory tests (blood)

  Change from Baseline blood abnormalities at 12 month

• Western Ontario and McMaster Universities Arthritis Index (WOMAC) score

  Change from Baseline WOMAC score at 12 month

• Knee injury and Osteoarthritis Outcome Score (KOOS)

  Change from Baseline KOOS score at 12 month

• International knee documentation committee (IKDC)

  Change from Baseline IKDC score at 12 month

• Cartilage damage evaluation through knee MRI

  Change from Baseline cartilage morphology at 12 month

• SF-36 questionnaire

  Change from Baseline SF-36 score at 12 month

• Serum inflammatory cytokine, acute phase reactant, bone turnover marker

  Change from Baseline cytokine level, acute phase reactant, bone turnover marker level at 12 month

• Cartilage damage evaluation through knee x-ray

  Change from Baseline cartilage and bone morphology at 12 month

Study Arms (2)

MASTER cell

EXPERIMENTAL

Intraarticular injection of Catholic MASTER cell, 1 time, 1 x 10\^8 cells/DMEM 5cc, into knee joint of patients with osteoarthritis

Biological: Catholic MASTER cell

Saline

PLACEBO COMPARATOR

Intraarticular injection of saline, 1 time, 5cc, into knee joint of patients with osteoarthritis

Other: Saline

Interventions

Catholic MASTER cell BIOLOGICAL

Injection of CATHOLIC MASTER cells 1 x 10\^8 cells/DMEM 5cc into knee of patents with osteoarthritis

MASTER cell

Saline OTHER

Injection of saline 5cc into knee of patents with osteoarthritis

Saline

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20-80
• diagnosed with knee osteoarthritis (OA) according to ACR classfication criteia for knee OA
• symptomatic OA that lastede for at least 3 months before screening
• Baseline Pain VAS ≥50 mm
• treated with medication such as acetaminophen, tramadol, NSAID for at least 1month due to OA pain
• X-ray Kellgren-Lawrence grade 1\~4
• volauntarily enrolled with informed consent
• no improvement with medical treatment for at least 3 months

You may not qualify if:

• disease in spine or lower extremities that can affect the outcome of index knee
• surgery on lower extremities within 6month before injection or planned
• joint symptoms that can affect the interpretation of the trial data or prevent the subject from enrollement including but not limited to symptomatic fracture, fibromyalgia, rheumatoid arthritis, reactive arthritis
• steroid injection to the index knee within preivious 3months
• hyaluronic acid injection to the index knee within preivious 6months
• underwent cell therapy or gene therapy in the past
• more than 3 times upper normal limit in one or more of the followings: serum creatinine, bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or more than 3 times upper normal limit in two or more of the followings: bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
• participation in a different clinical trial other than this within 4 weeks after initiation of the current study
• use (reccuent use or addiction) of substances that can affect pain sensation such as narcotics
• females of childbearing age who do not consent to effective contraceptive methods during the study period
• pregnant or lactating woman
• malignancy
• considered to be inappropriate for the trial by investigators

Sponsors & Collaborators

• Seoul St. Mary's Hospital: lead

Study Sites (1)

Catholic University of Korea

Seoul, 06950, South Korea

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ji Hyeon Ju, MD, PhD

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ji Hyeon Ju, MD, PhD

CONTACT

82-2-2258-6893; juji@catholic.ac.kr

Jennifer Lee, MD, PhD

CONTACT

82-2-2258-6893; poohish@naver.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: January 27, 2020
• Study Start: November 15, 2019
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2022
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

KR (1)