Phase 2B Clinical Study of Chondrogen for Treatment of Knee Osteoarthritis

Phase 2B: Randomized Double-Blinded Clinical Study of Chondrogen for Treatment of Knee Osteoarthritis

Primary osteoarthritis is a debilitating disease characterized by extensive damage to the joints and excruciating pain leading to loss of activity and depression. Despite advances in diagnosis, the quest for the development of a disease-modifying osteoarthritis drug has proven unsuccessful. Human cartilage only has limited regenerative potential. Transplantation is a promising strategy given the high proliferative capacity of MSCs and their potential to differentiate into cartilage-producing cells - chondrocytes. The acquisition of MSC does not require invasive surgical intervention or cartilage extraction from other sites as required by other cell-based strategies. The investigators inject allogeneic human mesenchymal stem cells to the cartilage lesions in patients via intra-articular injection method, and to investigate the efficacy and safety.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Biological: Chondrogen; Biological: Placebo

Detailed Description

Osteoarthritis is one of the commonest diseases in the world, with a global disease burden of 83%. Plain radiograph remained the main modality in diagnosing osteoarthritis. Chondrogen is a mesenchymal stem cell-derived from umbilical cord tissue product. The mesenchymal stem cell is used for the study because of its ability to proliferate and differentiate into various tissues such as chondrocytes, adipocytes, and osteocytes. Various clinical studies have been conducted for arthritis, orthopedic, joint, and cartilage.

This study will enroll 100 patients age 30-70 years old. They will be divided into 2 groups which are the group which will receive the investigational drug (ChondrogenTM and HA) and another group will receive a placebo (saline and HA). It will be a randomized double-blinded study where the participants and the investigator would not know what are the things being received. This study will be conducted for 24 months. The injection will be given on the baseline day after screening the volunteers. The patients will be assessed on VAS, WOMAC, IKDC, KOOS PROMIS29, the interleukins, and MRI.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Prakash Nathan, MBA; Phone Number: 03-88902968; Email: research@meluhalifesciences.com
• Study Contact Backup: Name: Raisah Hadi, MSC; Phone Number: 105 03-88902968; Email: research@meluhalifesciences.com

Study Locations

• Malaysia
  • Kuala Lumpur
    • Cheras, Kuala Lumpur, Malaysia, 56000
      • Department of Orthopedic & Traumatology, Faculty of Medicine, Hospital Canselor Tuanku Mukhriz, UKM Medical Centre, Jalan Yaacob Latiff, Bandar Tun Razak, Cheras, 56000 Kuala Lumpur.
      • Contact: Badrul Akmal Hisham Md. Yusoff, MBBS; Phone Number: 012-5196119; Email: badrul.akmal.hisham.md.yusof@ppukm.ukm.edu.my
      • Principal Investigator: Badrul Akmal Hisham Md. Yusoff, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 30-70 years old
• No serious infection, chronic diseases, diabetes and tuberculosis
• Idiopathic or secondary osteoarthritis of the knee with grade 1-3 defined by the modified Kellgren-lawrence classification
• Written informed consents were obtained from all subjects.

Exclusion Criteria:

• Pregnant or lactating women
• Women of childbearing potential unwilling to use two forms of contraception
• Cognitively impaired adults
• Presence of large meniscal tears
• Inflammatory or post-infectious arthritis
• More than 5 degrees of varus or valgus deformity
• Kellgren Lawrence grade 4 osteoarthritis in two compartments in persons over 60 years of age
• Intra-articular corticosteroid injection within the 3 previous months
• Major neurologic deficit
• Arthroscopy during the previous 6 months
• Poorly controlled diabetes mellitus
• Immunosuppressive or anticoagulant treatment
• NSAID therapy within 15 days prior to inclusion in the study
• Serious medical illness with a life expectancy of less than 1 year
• Prior admission for substance abuse
• Body Mass Index (BMI) of 40 kg/m2 or greater
• Patient receiving experimental medication or participating in another clinical study within 30 days of signing the informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Participant of Phase 2B Clinical Study Chondrogen; 50 participants will receive the investigational drug (Chondrogen and Hyaluronic Acid) through the intra-articular injection method. The participants will receive the investigational drug one time. The injection will be provided to the participant on the baseline day.	Biological: Chondrogen; Mesenchymal stem cell-derived from umbilical cord Wharton Jelly and hyaluronic acid; Other Names: Mesenchymal Stem Cell
Placebo Comparator: Placebo Participant of Phase 2B Clinical Study Chondrogen; 50 participants will receive the placebo (Saline and Hyaluronic Acid) through the intra-articular injection method. The participants will receive the investigational drug one time. The injection will be provided to the participant on the baseline day.	Biological: Placebo; Consist of saline and hyaluronic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS score	Change from Baseline in Visual Analogue Scale (VAS)	12 months
WOMAC score	Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index Score (WOMAC)	12 months
IKDC score	Change from Baseline in knee function change and improvement (IKDC)	12 months
KOOS score	Change from Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS29 score	Change in Patient-Reported Outcomes Measurement Information System (PROMIS29) scores	12 months
Kellegren-Lawrence grading	Number of participants evaluated by X-ray and MRI of knee OA from baseline Kellegren-Lawrence grading system.	12 months
Interleukins	Changes of interleukins (IL-1b, IL-6, PGE-2, TGF-b, TNF-a, IGF-1) of articular cavity fluid from baseline to week 12	12 months

Collaborators and Investigators

• Sponsor: Meluha Life Sciences SDN BHD
• Investigators: Principal Investigator: Badrul Akmal Hisham, MBBS, PPUKM

Study record dates

Study Major Dates

• Study Start (Anticipated): October 31, 2020
• Primary Completion (Anticipated): September 30, 2021
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: August 17, 2020
• First Submitted That Met QC Criteria: August 17, 2020
• First Posted (Actual): August 20, 2020

Study Record Updates

• Last Update Posted (Actual): August 20, 2020
• Last Update Submitted That Met QC Criteria: August 17, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: Chondrogen

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No