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

Osteoarthritis, Knee Clinical Trial

— MSC-OA  

Official title:

Randomized Double-blind Clinical Study of Intra Articular Injection of Catholic MASTER Cell in Knee Osteoarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04240873
• Other study ID #: KC19CNSI0469
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 15, 2019
• Est. completion date: March 31, 2022

Study information

• Verified date: January 2020
• Source: Seoul St. Mary's Hospital
• Contact: Ji Hyeon Ju, MD, PhD
• Phone: 82-2-2258-6893
• Email: juji[@]catholic.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

1. objective

• safety and efficacy evalaution of MASTER cells injected into knee of patients with osteoarthritis

2. background

• 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

3. Hypothesis

• Intra articular injection of MASTER cells will show safety and efficacy in terms of pain and functional improvement.

4. 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

1. inclusion : age 20-80yrs, diagnosed with OA according to ACR criteria for knee OA, baseline pain VAS equal or more than 50mm

2. 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)

5) evaluation

• primary outome : compare the number and proportion of of adverse event and lab test abnormalities between the two arms

• secondary outome

1. change of 100mm pain VAS

2. change of Western Ontario and McMAster Universities Osteoarthritis (WOMAC) pain VAS, IKDC, KOOS total score

3. change WOMAC sub scale, IKDC, KOOS

4. chagne of KHAQ

5. change of MRI indices

6. change of x-ray( joins space narrowing)

7. change of serum ESR/CRP, CTX-II

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age 20-80

2. diagnosed with knee osteoarthritis (OA) according to ACR classfication criteia for knee OA

3. symptomatic OA that lastede for at least 3 months before screening

4. Baseline Pain VAS =50 mm

5. treated with medication such as acetaminophen, tramadol, NSAID for at least 1month due to OA pain

6. X-ray Kellgren-Lawrence grade 1~4

7. volauntarily enrolled with informed consent

8. no improvement with medical treatment for at least 3 months

Exclusion Criteria:

1. disease in spine or lower extremities that can affect the outcome of index knee

2. surgery on lower extremities within 6month before injection or planned

3. 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

4. steroid injection to the index knee within preivious 3months

5. hyaluronic acid injection to the index knee within preivious 6months

6. underwent cell therapy or gene therapy in the past

7. 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)

8. participation in a different clinical trial other than this within 4 weeks after initiation of the current study

9. use (reccuent use or addiction) of substances that can affect pain sensation such as narcotics

10. females of childbearing age who do not consent to effective contraceptive methods during the study period

11. pregnant or lactating woman

12. malignancy

13. considered to be inappropriate for the trial by investigators

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• Catholic MASTER cell
Injection of CATHOLIC MASTER cells 1 x 10^8 cells/DMEM 5cc into knee of patents with osteoarthritis

Other:
• Saline
Injection of saline 5cc into knee of patents with osteoarthritis

Locations

Country	Name	City	State
Korea, Republic of	Catholic University of Korea	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul St. Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adverse event according to CTCAE 5.0, clinically meaningful abnormalites in laboratory tests (blood)		Change from Baseline blood abnormalities at 12 month
Primary	Western Ontario and McMaster Universities Arthritis Index (WOMAC) score		Change from Baseline WOMAC score at 12 month
Primary	Knee injury and Osteoarthritis Outcome Score (KOOS)		Change from Baseline KOOS score at 12 month
Primary	International knee documentation committee (IKDC)		Change from Baseline IKDC score at 12 month
Primary	Cartilage damage evaluation through knee MRI		Change from Baseline cartilage morphology at 12 month
Primary	SF-36 questionnaire		Change from Baseline SF-36 score at 12 month
Primary	Serum inflammatory cytokine, acute phase reactant, bone turnover marker		Change from Baseline cytokine level, acute phase reactant, bone turnover marker level at 12 month
Primary	Cartilage damage evaluation through knee x-ray		Change from Baseline cartilage and bone morphology at 12 month