Evaluate Safety and Explore Efficacy of SMUP-IA-01 in Patients With Knee Osteoarthritis

NCT04037345 | Completed Phase 1

• 1 other identifier: MP-SMUP-IA-01-P01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is performed with patients with knee osteoarthritis who were radiologically diagnosed with Kellgren-Lawrence (K\&L) grade 2 or 3. Subjects who voluntarily signed consent form and met inclusion/exclusion criteria, were evaluated eligible and participated in this trial. Investigator selected knee to be evaluated (right or left) and administered investigational product to selected knee on Day 1. A total of 3 or 6 subjects will be enrolled in low-dose or mid-dose group each, and 6 subjects will be enrolled in high-dose group. The study used a dose escalation scheme (from low-dose to high-dose) to determine the maximum tolerated dose (MTD).

Conditions

Knee Osteoarthritis

Keywords

human umbilical cord blood derived mesenchymal stem cells; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change of total score in WOMAC (Western Ontario and McMaster University Osteoarthritis Index) compared to baseline at 6 months after treatment

  Change of total scorein WOMAC compared to baseline at 6 months after treatment. WOMAC consists of three subscales: pain, stiffness, and physical function, and is performed on baseline (visit 2) and final (Visit 8) visits. Total of 24 questions are evaluated with 5 questions for pain, 2 questions for stiffness, and 17 questions for physical function. Each question is scored between 0 point (no symptom) \~ 4 points (severe symptoms) scale, and the total score is between 0 point (no symptoms) \~ 96 points (higher score representing worse symptoms).

  Baseline, Month 6

Secondary Outcomes (7)

• Change of score in WOMAC three subscales (Pain, stiffness, physical function)compared to baseline at 6 months after treatment

  Baseline, Month 6

• Change of score in 100 mm VAS (Visual Analogue Scale) compared to baseline

  Baseline, Month 1, Month 2, Month 3, Month 6

• Change of score in IKDC(International Knee Documentation Committee)compared to baseline

  Baseline, Month 1, Month 2, Month 3, Month 6

• Change of score in WORMS(Whole-Organ Magnetic Resonance iMaging Score) compared to baseline at 6 months after treatment

  Baseline, Month 6

• Change in K&L(Kellgren-Lawrence) grade compared to the baseline at 3 months and 6 months after treatment

  Baseline, Month 3, Month 6

Study Arms (3)

SMUP-IA-01(low-dose)

EXPERIMENTAL

A single knee administration of SMUP-IA-01 (low-dose, 4.0 x 10\^6 cells/2mL) (2 ml of 1% sodium hyaluronate injection is administered before administration of SMUP-IA-01)

Biological: SMUP-IA-01(low-dose)

SMUP-IA-01(mid-dose)

EXPERIMENTAL

A single knee administration of SMUP-IA-01 (mid-dose, 1.0 x 10\^7 cells/2mL) ( 2 ml of 1% sodium hyaluronate injection is administered before administration of SMUP-IA-01)

Biological: SMUP-IA-01(mid-dose)

SMUP-IA-01(high-dose)

EXPERIMENTAL

A single knee administration of SMUP-IA-01 (high-dose, 2.0 x 10\^7 cells/2mL) (2 ml of 1% sodium hyaluronate injection is administered before administration of SMUP-IA-01)

Biological: SMUP-IA-01(high-dose)

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: Human umbilical cord blood-derived mesenchymal stem cells

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: Human umbilical cord blood-derived mesenchymal stem cells

SMUP-IA-01(mid-dose)

SMUP-IA-01(high-dose) BIOLOGICAL

A single knee administration of SMUP-IA-01(high-dose, 2.0 x 10\^7 cells/2mL)

Also known as: Human umbilical cord blood-derived mesenchymal stem cells

SMUP-IA-01(high-dose)

Eligibility Criteria

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

You may qualify if:

• Male and female over 19 years of age
• Subject with knee osteoarthritis (OA) and were diagnosed K\&L grade 2 or 3 in radioactive examination at time of screening
• Subject with more than 40mm joint pain on the 100-mm VAS, at the time of screening
• Subject who were diagnosed as knee osteoarthritis by American College of Rheumatology (ACR) guideline criteria, at the time of screening
• Subject with Body mass index (BMI) ≤35 kg/m2 at the time of screening
• Subject with ligament instability ≤Grade II (grade o: no ligament instability, grade I: 0 \~ 5㎜, grade Ⅱ: 5 \~ 10 ㎜, grade Ⅲ: \> 10 ㎜) at the time of screening
• Subject who agree to maintain contraception during study period
• Subject who voluntarily agreed to participate in the study, and signed informed consent

You may not qualify if:

• Subject with myocardial infarction, congestive heart failure, and other severe heart disease or hypertension (or medical history of hypertension) that are not controlled below 140/90mmHg even with treatment with more than three(3) antihypertensive drugs
• Subject with serious medical conditions other than cardiovascular disease
• Subject with, or with a medical history of auto-immune diseases
• Subject with an infection that requires parenteral antibiotic administration.
• Subject with a medical history of mental disorder or epilepsy
• Subject with chronic inflammatory joint diseases such as rheumatoid arthritis (e.g., osteoarthritis with infectious joint disease, gouty arthritis, and osteoarthritis)
• Subject who had surgery or radiation therapy on knee joint area, or have not recovered from side effects of knee joint surgery within 12 weeks before screening
• Subject who are pregnant or lactating
• Subject abuse alcohol 10 times a week or smoke 25 cigarettes a day
• Subject who were diagnosed with cancer within 5 years before screening
• Subject who particiapted in another clinical trial within 4 weeks before screening of this clinical trial
• Subject who were administered with immunosuppressnats such as cyclosporin A or azathioprine within 6 weeks before screening
• Subject who had intra-articular administration such as sodium hyaluronate injections within 6 month before screening
• Subject who are suffering from skin disease or considered inappropriate for injection in the injection site
• Subject who has history of allergic response to hyaluronate injections or DMSO (cryopreservative) or Gentamicin (antibiotics)

Sponsors & Collaborators

• Medipost Co Ltd.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Myungchul Lee, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 30, 2019
• Study Start: October 7, 2019
• Primary Completion: November 12, 2020
• Study Completion: November 12, 2020
• Last Updated: February 24, 2021

Record last verified: 2020-08

Locations

KR (1)