Follow-up Study for Participants of Jointstem Phase 3 Clinical Trial

• Sponsor: R-Bio (Industry)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04427930
• Collaborator: (none)
• Enrollment: 260
• Locations: 4
• Arms: 2
• Anticipated Duration (Months): 92.6
• Patients Per Site: 65
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The purpose of this follow-up study is to investigate the efficacy and safety of autologous Adipose Tissue derived Mesenchymal stem cells (JOINTSTEM®) in patient with severe Knee Osteoarthritis.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Biological: JOINTSTEM; Drug: Saline	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 260 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Long-Term Safety and Efficacy Extension Study Of Autologous Adipose-Derived Mesenchymal Stem Cells 『JOINTSTEM』 in Patients With Knee Osteoarthiritis: A Phase III Extension Study
• Actual Study Start Date: Apr 13, 2020
• Anticipated Primary Completion Date: Dec 23, 2026
• Anticipated Study Completion Date: Dec 30, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: JOINTSTEM Long Term Follow-up after Jointstem Transplantation	Biological: JOINTSTEM; Autologous Adipose Tissue derived MSCs
Placebo Comparator: Saline	Drug: Saline; Saline

Outcome Measures

Primary Outcome Measures

1. Adverse Events [54 Months]

   Incidence of adverse events from baseline to 54 monthss

Secondary Outcome Measures

1. Change of Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) scores from baseline [54 Months]

   Pain, stiffness, and physical function of the knee will be measured by the WOMAC score

2. WOMAC 3 subscale score [54 Months]

   Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC)

3. SF-36 [54 Months]

   The SF(Short Form)-36 Health Survey is a 36-item, patient-reported survey of patient health.

4. Measuring of Kellgren-Lawrence grade [6, 18 Months]

   Measuring of Kellgren-Lawrence grade through X-ray

5. Measuring of Femoro-tibial anatomical angle(FTA) [6, 18 Months]

   Measuring of FTA through X-ray

6. Measuring of Hip-Knee-Ankle angle(HKA) [6, 18 Months]

   Measureing of HKA through X-ray

7. Measuring of Joint Space Width [6, 18 Months]

   measuring Joint Space Width through X-ray

8. MRI scan [6, 18 Months]

   MRI perform to measure Modified WORMS (Whole-Organ Magnetic Resonance Imaging Score)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participants of Jointstem Phase 3 Clinical Trial

• Participates who signed informed consent document of this study

Exclusion Criteria:

• No applicable

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Keimyung University Dongsan Medical Center	Daegu		Korea, Republic of	42601
2	KyungHee University Gangdong Hospital	Seoul		Korea, Republic of	05278
3	Gangnam Severance Hospital	Seoul		Korea, Republic of	06273
4	The Catholic University of Korea, Seoul ST. Mary's Hospital	Seoul		Korea, Republic of	06591

Sponsors and Collaborators

• R-Bio

Investigators

• Principal Investigator: KANGIL KIM, KyungHee University Gangdong Hospital
• Principal Investigator: WOOSUK LEE, Gangnam Severance Hospital
• Principal Investigator: KICHEOR BAE, Keimyung University Dongsan Medical Center
• Principal Investigator: YONG IN, The Catholic University of Korea

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: R-Bio
• ClinicalTrials.gov Identifier: NCT04427930
• Other Study ID Numbers: BSR-CTph3-JS1_FU
• First Posted: Jun 11, 2020
• Last Update Posted: Sep 25, 2020
• Last Verified: Sep 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

No Results Posted as of Sep 25, 2020