Clinical Trial to Evaluate Efficacy and Safety of SMUP-IA-01 in Patients With Knee Osteoarthritis

NCT05182034 | Completed Phase 2

• 1 other identifier: MP-SMUP-IA-01-P02
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 5

Brief Summary

This clinical trial is for patients who have been diagnosed with Kellgren-Lawrence (K\&L) Grade 2 or 3 knee osteoarthritis on radiographic examination. Only subjects who voluntarily agree to participate by filling out the written Informed Consent document will undergo screening for subject selection (inclusion/exclusion) criteria, at which time the severity of OA in each knee will be used to determined which knee will be treated (index knee - i.e., the more severely affected knee), and enroll in this study.

Conditions

Knee Osteoarthritis

Keywords

human umbilical cord blood derived mesenchymal stem cells; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change in the WOMAC(Western Ontario and McMaster University Osteoarthritis Index) total score at post-dose 52 weeks from baseline

  Total score is between 0 point (no symptoms) \~ 96 points (higher score representing worse symptoms).

  Baseline, 52 week

Secondary Outcomes (9)

• Change amount of WOMAC total score at post-dose 24 weeks from the baseline

  Baseline, 24 week

• Chage amount of WOMAC score by item (pain, stiffness, physical function) at post-dose 24 weeks and 52 weeks from the baseline

  Baseline, 24 week, 52 week

• Chage amount of 100-mm VAS((Visual Analogue Scale) at post-dose 1 week, 4 weeks, 8 weeks, 12 weeks, 24 weeks and 52 weeks from the baseline

  Baseline, 1 week, 4 week, 8 week, 12 week, 24 week, 52 week

• Chage amount of IKDC(International Knee Documentation Committee) at post-dose 1 week, 4 weeks, 8 weeks, 12 weeks, 24 weeks and 52 weeks from the baseline

  Baseline, 1 week, 4 week, 8 week, 12 week, 24 week, 52 week

• Change in the WOMAS(whole-organ magnetic resonance imaging score) at post-dose 52 weeks from the baseline

  Baseline, 52 week

Study Arms (3)

Study Group 1: SMUP-IA-01 (low dose)

EXPERIMENTAL

Investigational Product - 4.0×10\^6 cells/2 mL of SMUP-IA-01 (2 ml of 1% sodium hyaluronate injection is administered before administration of SMUP-IA-01)

Biological: SMUP-IA-01(low dose)

Study Group 2:SMUP-IA-01 (mid dose)

EXPERIMENTAL

Investigational Product - 1.0×10\^7 cells/2 mL of SMUP-IA-01 (2 ml of 1% sodium hyaluronate injection is administered before administration of SMUP-IA-01)

Biological: SMUP-IA-01(mid dose)

Active Control Group

ACTIVE COMPARATOR

Investigational Product - 2 ml of 1% sodium hyaluronate (2 ml of sodium chloride injection is administered before administration of 1% sodium hyaluronate)

Drug: Active Control Group Sodium chloride

Interventions

SMUP-IA-01(low dose) BIOLOGICAL

A single knee administration of SMUP-IA-01(low-dose, 4.0 x 10\^6 cells/2mL)

Also known as: SMUP allogenic cord blood-derived mesenchymal stem cell (SMUP-Cell)

Study Group 1: SMUP-IA-01 (low dose)

SMUP-IA-01(mid dose) BIOLOGICAL

A single knee administration of SMUP-IA-01(mid-dose, 1.0 x 10\^7 cells/2mL)

Also known as: SMUP allogenic cord blood-derived mesenchymal stem cell (SMUP-Cell)

Study Group 2:SMUP-IA-01 (mid dose)

Active Control Group Sodium chloride DRUG

A single knee administration of Sodium chloride

Also known as: Sodium chloride

Active Control Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are ≥ 19 years of age on the date on which the consent form was signed
• Patients diagnosed with knee osteoarthritis in at least one knee according to the clinical and radiological definition criteria of American College of Rheumatology (ACR) guidline at screening visit
• Patients with knee OA corresponding to K\&L Grade 2 or 3 on radiographic examination at screening visit
• Patients with less than 35 of BMI at screening visit
• Patients who voluntarily decide to participate and sign the consent form
• Patients who have persistent symptoms despite having undergone a reasonable trial of standard therapy (i.e., for a minimum of 3 months)

You may not qualify if:

• Patients with any of the following diseases.
• \- infectious arthritis, autoimmune or inflammatory joint diseases, gout, recurrent pseudogout, Paget's disease, intra-articular displaced fracture, ochronosis, acromegaly, haemochromatosis, Wilson's disease, genetic disease (hyperkinesia etc.), genetic collagen disorder, etc.
• Patients who have ever undergone surgery or radiotherapy in the knee joint area within the 12 weeks prior to the screening visit date, or who have not been recovered from its side effect yet.
• Patients with SIF (Subchondral insufficiency fracture) corresponding to type II of the RPOA (rapidly progressive osteoarthritis).
• Patients whose physical examination results show severe degree of ligament instability.
• Patients who have ever been given any intraarticular drug injection (i.e., hyaluronic acid injection, etc.) in to-be-treated (index) knee within the 6 months, prior to the screening visit date.
• Patients who have ever been given steroids via intraarticular injection in to-be-treated (index) knee within the 12 weeks prior to the screening visit date.
• Patients who have ever taken medications or given therapy below within the past 2 weeks on the basis of screening visit date. However, if patients have 14 days of wash-out period, the patient is allowed to participate.
• drugs containing the ingredient of glucosamine, chondroitin sulfate, or diacerein
• drugs containing herbal ingredient or herbal drugs for knee OA pain relief
• anti-inflammatory analgesics or NSAIDs (prescription/non-prescription drugs). (However, patients who take acetaminophen and have 3 days of wash-out period are allowed to participate.)
• oral steroids
• hospital physiotherpy or oriental medicine treatment (buhang, acupunture, moxibustion etc.)
• Patients who have skin disease on injection site or who are judged inappropriate for intra-articular injection on to-be-treated knee.
• Patients who are judged unsuitable for MRI scanning (3.0 Tesla or higher) due to an insertion of metal material (i.e., heart pacemaker, cerebral aneurysm clip, etc.) or obstructive phobia. However, patients who have an insertion of metal material that is not affected by the magnetic field is allowed to participate

Sponsors & Collaborators

• Medipost Co Ltd.: lead

Study Sites (5)

Seoul Nation University Bundang Hospital

Gyeonggi-do, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Korea University Anam Hospita

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Myungchul Lee, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

• Chonghyuk Choi, MD, PhD

  Severance Hospital

  PRINCIPAL INVESTIGATOR

• Chongbum Chang, MD, PhD

  Seoul Nation University Bundang Hospital

  PRINCIPAL INVESTIGATOR

• Seungbum Han, MD, PhD

  Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

• Sunghwan Kim, MD, PhD

  Gangnam Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2021
• First Posted: January 10, 2022
• Study Start: February 24, 2022
• Primary Completion: October 17, 2023
• Study Completion: October 17, 2023
• Last Updated: February 5, 2025

Record last verified: 2025-02

Locations

KR (5)