Safety and Efficacy of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

A Multi-center, Randomized, Double-blind, Parallel, Placebo-controlled Phase I/2a Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-RA Inj. for Moderate to Severe Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03618784
• Other study ID #: K0202
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 11, 2018
• Est. completion date: May 13, 2022

Study information

• Verified date: October 2022
• Source: Kang Stem Biotech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Safety and Efficacy of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid arthritis

Description:

Phase 1: Single center, open Phase 2a : Multi-center, randomized, double-blind, parallel, placebo Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-RA Inj. for Moderate to Severe Rheumatoid arthritis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 13, 2022
• Est. primary completion date: October 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

1. of either gender, 19-80years old

2. Subjects must be diagnosed according to the 2010 ACR/EULAR criteria for at least 12 weeks duration.

3. Subjects must be diagnosed with ACR functional class I. II, III

4. = 6 tender joints, swollen joints (68 joint count) at Screening

5. Subject who has moderate to severe disease activity (DAS28-ESR>3.2) on screening visit

6. History of treatment for one of conventional DMARDs or biologic DMARDs or JAK inhibitors AND people diagnosed with either (a) or (b) by a trained person, or people that have potential side effects thus not qualified from using biologic DMARDs.

1. people that have no effect with permitted dose taking for more than 3 months

2. people with a history of side effects of relevant treatment

7. Subjects must be taking cDMARDs(including methotrexate, sulfasalazine, hydroxychloroquine, leflunomide) or tacrolimus of stable dose More than 12 weeks before baseline visit and be willing to remain on stable dose throughout the study

8. If subject is currently administering steroids everyday, when steroid dose is converted into prednisolone oral dose, the subject should take a stable dose(=10mg/day) over 4 weeks on screening visit

9. In case of taking NASAIDs, Tramadol patients with stable amount of medication at least 2 weeks before screening visit.

10. During screening visit , patients with an ESR result of 28mm/hr; patients with a 1.0mg/dL or greater in a CRP testing

11. Subject who understands and voluntarily sign an informed consent form

Exclusion Criteria:

1. Subjects who is diagnosed ACR function class IV Rheumatoid Arthritis

2. Patients who are judged by the PI(or Sub-I) to be unable to participate in clinical trials due to uncontrolled or unstable cardiovascular disease or severe blood disease

3. Subjects who has AIDS, other rheumatic disease(Crohn's disease, systemic lupus erythematosus, lyme disease, psoriatic arthritis, spondylarthropathy, infectious or reactive arthritis, reiter's syndrome, etc.)

4. Prior use of bDMARDs, within the following windows prior to baseline

• 24 weeks for Rituximab
• 10 weeks for Abatacept, Golimumab, Certolizumab pegol, Tocilizumab
• 7 weeks for Infliximab
• 4 weeks for Etanercept
• 3 weeks for Tofacitinib, Baricitinib

5. Subject who has history of hypersensitivity, heavy metal poisoning, etc. to drugs which is composed of similar components.

6. Subject who has treated intravenous, intramuscular steroid injection within 2 weeks before screening visit or intra-articular steroid injection within 4 weeks before screening visit

7. Subject who has administered ACTH(adrenocorticotropic hormone) agents within 4 weeks before screening visit

8. Subject who has undergone administration of any investigational drug within 30 days before screening visit.

9. Use of prohibited medication or inability to avoid the use of prohibited medication during the study

10. Pregnant, breast-feeding women

11. A female or male in their childbearing ages that is not willing to take proper contraceptive methods during a study

12. Subject who has sever dyshepatia (Serum creatinine level = 1.7mg/dl)

13. Subject who has severe renal dysfunction (ALT/AST/bilirubin value = 2 upper limit of the normal range at screening test)

14. Any other condition which the PI Judges would make patient unsuitable for study participation

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• FURESTEM-RA Inj
The allogeneic umbilical cord blood-derived mesenchymal stem cells of each dose level as below were mixed into an IV bag containing 100 ml of sterile saline solution and the IV bag was gently massaged to obtain homogeneous mixture of the cell suspension. Administer the constituted cell suspension by IV infusion to a subject. The infusion should be completed in 60 minutes using infusion pump. Dose level 1: 5.0 x 10^7 cells /body 3 repeated intravenous injection at 4 week intervals Dose level 2: 1.0 x 10^8 cells /body 3 repeated intravenous injection at 4 week intervals

Other:
• sterile saline
sterile saline 3 repeated intravenous injection at 4 week intervals Placebo were mixed into an IV bag containing 100 ml of sterile saline solution and the IV bag was gently massaged to obtain homogeneous mixture of the cell suspension. Administer the constituted cell suspension by IV infusion to a subject. The infusion should be completed in 60 minutes using infusion pump.

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Gangdong Kyung Hee University Hospital	Seoul
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	Kyung Hee University Hospital	Seoul
Korea, Republic of	Seoul Hospital attached to Soonchunhyang University	Seoul
Korea, Republic of	Seoul national University Boramae	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kang Stem Biotech Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of FURESTEM-RA Inj. - number of adverse events	Evaluate the number of adverse events Safety of FURESTEM-RA Inj.	4 weeks follow-up after treatment
Secondary	Efficacy as measured by ACR(American College of Rheumatology)20,50,70 reaction rate		16 weeks follow-up after treatment
Secondary	Efficacy as measured by EULAR (European League Against Rheumatism)reaction rate		16 weeks follow-up after treatment
Secondary	Efficacy as measured by DAS(Disease activity scores)28-ESR	DAS range is from = 3.2 (inactive) , >3.2 but = 5.1(moderate), >5.1(very active)	16 weeks follow-up after treatment
Secondary	Efficacy as measured by KHAQ(Korean Health assessment questionnaire)	KHAQ range is from 0 (clear) to 60 (severe)	16 weeks follow-up after treatment
Secondary	Efficacy as measured by CDAI (clinical disease activity index)	CDAI range is from 0 (clear) to 76 (severe)	16 weeks follow-up after treatment
Secondary	Efficacy as measured by 100mm Pain VAS(Visual analogue scale)	100mm Pain VAS range is from 0 (clear) to 100 (severe)	16 weeks follow-up after treatment
Secondary	Total number of use and consumed amount of rescue medicine		16 weeks follow-up after treatment
Secondary	Change in Cytokine(TNF-a, Interleukin (IL)-1b, IL-4,IL-6,IL-8,IL-10,IL-13,IL-17A,IL-21,IL-22)		16 weeks follow-up after treatment