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

Phase 2

Recruiting

• Conditions: Osteoarthritis, Knee
• Interventions: Drug: JointStem; Other: Placebo Control

• Registration Number: NCT04368806
• Lead Sponsor: Nature Cell Co. Ltd.

Brief Summary

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.

Detailed Description

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)

Study Timeline

• Study First Submitted: 2020-04-21
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-30
• Study Start: 2021-05-26
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-21
• Last Update Posted: 2025-07-24
• Primary Completion: 2026-12-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
JointStem	JointStem	Autologous Adipose tissue derived Mesenchymal Stem Cells(AdMSC)
Placebo	Placebo Control	Normal Saline with Autologous Serum

Primary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities Arthritis Index (WOMAC) function Score	Baseline and Week 48	Change from baseline in WOMAC function score at Week 48
Visual Analog Scale (VAS) score	Baseline and Week 48	Change from baseline on Visual Analog Scale (VAS) score at Week 48

Secondary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities Arthritis Index (WOMAC) subscale (Function)	Week 12, 24 and 36	Change from baseline in WOMAC subscale (Function) score at Week 12, 24, and 36
Western Ontario and McMaster Universities Arthritis Index (WOMAC) subscale (Pain)	Week 12, 24, 36, and 48	Change from baseline in WOMAC subscale (Pain) score at Week 12, 24, 36, and 48
Total Western Ontario and McMaster Universities Arthritis Index (WOMAC) score	Week 12, 24, 36, and 48	Change from baseline in total WOMAC score at Week 12, 24, 36, and 48
Visual Analog Scale (VAS) score	Week 12, 24 and 36	Change from baseline in VAS score at Week 12, 24 and 36
International Knee Documentation Committee (IKDC) score	Week 12, 24, 36, and 48	Change from baseline in IKDC score at Week 12, 24, 36, and 48
Kellgren-Lawrence grade	Week 48	Change from screening in Kellgren-Lawrence grade of knee osteoarthritis determined by X-ray at Week 48
36-Item Short Form health survey questionnaires (SF-36) score	Week12, 24, 36, and 48	Change from baseline in SF-36 score at Week 12, 24, 36, and 48
Number and amount of rescue medication use	Week 12, 24, 36, and 48	The number and amount of rescue medication use at Week 12, 24, 36, and 48

Trial Locations

Locations (9)

Keimyung University Dongsan Hospital; 🇰🇷 Daegu, Korea, Korea, Republic of

Kyung Hee University Medical Center; 🇰🇷 Seoul, Korea, Korea, Republic of

Kyung Hee University Hospital At Gangdong; 🇰🇷 Seoul, Korea, Korea, Republic of

Smg-Snu Boramae Medical Center; 🇰🇷 Seoul, Korea, Korea, Republic of

TriWest Research Associates; 🇺🇸 El Cajon, California, United States

BioSolutions Clinical Research Center; 🇺🇸 La Mesa, California, United States

Neurovations Research; 🇺🇸 Napa, California, United States

Newport Therapeutics; 🇺🇸 Newport Beach, California, United States

Source Healthcare; 🇺🇸 Santa Monica, California, United States