NCT04240873: MSC-OA

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

Status unknown Phase 1, PHASE2 Last updated 27 January 2020

What this trial tests

Phase 1, PHASE2 trial testing Catholic MASTER cell in Osteoarthritis, Knee in 24 participants. Status unknown.

Timeline

15 November 2019

Primary endpoint
31 March 2021

31 March 2022

Quick facts

Lead sponsor	Seoul St. Mary's Hospital
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	24
Start date	15 November 2019
Primary completion	31 March 2021
Estimated completion	31 March 2022
Sites	1 location across South Korea

Drugs / interventions tested

• Catholic MASTER cell — full drug profile →
• Saline

Conditions studied

• Osteoarthritis, Knee — all drugs for Osteoarthritis, Knee →

Sponsor

Seoul St. Mary's Hospital

Who can join

Adults 20 to 80, any sex, with Osteoarthritis, Knee. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Clinical Trials of Mesenchymal Stromal Cells Therapy.
   Kouchakian MR, Baghban N, Moniri SF, Baghban M, et al · · 2021 · cited 30× · PMID 34745268 · DOI 10.1155/2021/1634782
2. Intra-Articular Injection of Human Bone Marrow-Derived Mesenchymal Stem Cells in Knee Osteoarthritis: A Randomized, Double-Blind, Controlled Trial.
   Lee BW, Lee JJ, Jung JY, Ju JH. · · 2025 · cited 16× · PMID 39874108 · DOI 10.1177/09636897241303275
3. Challenges and opportunities of pharmacological interventions for osteoarthritis: A review of current clinical trials and developments.
   Vrouwe JPM, Burggraaf J, Kloppenburg M, Stuurman FE. · · 2021 · cited 16× · PMID 36474768 · DOI 10.1016/j.ocarto.2021.100212
4. Stem cell injections for osteoarthritis of the knee.
   Whittle SL, Johnston RV, McDonald S, Worthley D, et al · · 2025 · cited 11× · PMID 40169165 · DOI 10.1002/14651858.cd013342.pub2
5. Mesenchymal Stromal Cell-Based Therapy-An Alternative to Arthroplasty for the Treatment of Osteoarthritis? A State of the Art Review of Clinical Trials.
   Maleitzke T, Elazaly H, Festbaum C, Eder C, et al · · 2020 · cited 8× · PMID 32630066 · DOI 10.3390/jcm9072062