Mesenchymal Stem Cells for The Treatment of Knee Osteoarthritis (KOA).

NCT04893174 | Unknown Phase 1 DMC

• 1 other identifier: UMC119-06-05-KOA-01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The clinical study with UMC119-06-05 is designed to investigate the safety in patients with mild to moderate knee osteoarthritis (KOA). This will be a dose escalation, open label, single-center study in adult with mild to moderate knee osteoarthritis. UMC119-06-05 is ex vivo cultured human umbilical cord tissue-derived mesenchymal stem cells product which is intended for treatment of knee osteoarthritis.

Conditions

Osteoarthritis, Knee

Keywords

KOA

Outcome Measures

Primary Outcomes (1)

• The incidence and frequency of adverse events related to administration of UMC119-06-05.

  Incidence of Treatment-Emergent Adverse Events (TEAEs). Incidence of withdrawals due to Adverse Events(AEs).

  1 months from the day of administration

Secondary Outcomes (5)

• Changes of total score in the Western Ontario and McMaster (WOMAC) assessment on the target knee.

  from baseline up to 52 weeks after administration

• Changes of arthritis pain on target knee using the 100-mm visual-analogue scale (VAS).

  from baseline up to 52 weeks after administration

• Whole Organ Magnetic Resonance Imaging Score (WORMS).

  from baseline up to 52 weeks after administration

• Changes in Kellgren-Lawrence (K-L) grading and joint space on target knee.

  from baseline up to 52 weeks after administration

• Amount of rescue medications required.

  at first 4 weeks, first 28 weeks and the whole study period.

Study Arms (1)

UMC119-06-05

EXPERIMENTAL

Human Umbilical Cord Derived-Mesenchymal Stem Cells. Subjects will receive a single-dose intra-articular (IA) injection of UMC119-06-05 followed by an IA injection of hyaluronic acid.

Biological: UMC119-06-05; Device: Hyaluronic acid

Interventions

UMC119-06-05 BIOLOGICAL

Subjects will receive a single-dose IA injection of UMC119-06-05 followed by an IA injection of hyaluronic acid. Cohort 1: Low does UMC119-06-05 Cohort 2: High does UMC119-06-05

UMC119-06-05

Hyaluronic acid DEVICE

IA injection of hyaluronic acid.

UMC119-06-05

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ambulatory subjects with osteoarthritis of the knee with symptoms for at least 3 months, that may be taking conservative therapy (e.g. oral anti-inflammatory medication), and/or undergoing physical therapy. In subjects with bilateral knee osteoarthritis, the more symptomatic knee will be the target knee.
• Subjects of age between ≥40 through ≦ 90 years.
• Subject diagnosed with knee osteoarthritis of grade II and III according to the Kellgren-Lawrence Grading Scale on the target knee.
• Subject with joint pain equal or greater than 7 (total pain score 24 point) on the target knee assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
• Subject or legal guardian is willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided, and has had the opportunity to discuss the study with the investigator or designee.
• Women of child-bearing potential should have a negative urine pregnancy test prior to administration of investigational product, and the subject must agree within at least 4 weeks after the study administration to use a double barrier method of birth control.UNLESS they meet the following criteria:(1) Post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels \> 40mIU/mL, OR; (2) 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy.
• If a male and heterosexually active with a female of childbearing potential, the subject must agree within at least 4 weeks after the study administration to use a double barrier method of birth control (or must have been surgically sterilized) and to not donate sperm.

You may not qualify if:

• Subjects with body mass index (BMI) over 40.
• Subjects with knee deformity (knee varus or valgus greater than 10 degrees) on the target knee.
• Subjects with acute inflammation or tense effusion (e.g., infection), or bleeding on the target knee as judged by principal investigator (PI).
• Subjects with ligament instability (cruciate ligaments or collateral ligaments) or ligament laxity of the target knee as judged by PI.
• Subjects with a history of surgery of articular injury, ligament reconstruction and meniscus repair on the target knee joint within previous 6 months.
• Subjects with history of arthroscopic surgery in the target knee in the past 6 months or planned to have arthroscopy surgery during the trial period (e.g., scheduled for/awaiting arthroscopy or a knee replacement procedure)
• Subjects with history of knee replacement procedure on the target knee.
• Subjects with known history of osteoarthritis of hip or ankle.
• Subjects with known history of any systemic autoimmune rheumatic disease including but not limited to: Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, lymphoma, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis.
• Subjects with Rheumatoid Factor levels (\>15.9 IU/mL) in laboratory tests.
• Subjects with joint diseases (except knee osteoarthritis) or infectious arthritis on the target knee considered by investigator not eligible to enter the study.
• Subjects who are known to be infected with HIV.
• Subjects with active hepatitis B or active hepatitis C.
• Subjects who have a significant concomitant illness as judged by principal investigator (PI) including, but not limited to:
• Severe renal insufficiency (eGFR \< 30 mL/min/1.73 m2); or

Sponsors & Collaborators

• Meridigen Biotech Co., Ltd.: lead

Study Sites (1)

Taipei Medical University Hospital

Taipei, 110301, Taiwan

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Claire Liao, MS

CONTACT

+886-2-8978-7777; claire.liao@meridigen.com

Joseph Chen, MS

CONTACT

+886-2-8978-7777; joseph.chen@meridigen.com

Study Design

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

Model Details: Cohort 1 : Low does UMC119-06-05 + Hyaluronic acid； Cohort 2 : High does UMC119-06-05 + Hyaluronic acid

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 19, 2021
• Study Start: September 15, 2022
• Primary Completion: September 1, 2024
• Study Completion: June 1, 2025
• Last Updated: December 4, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)