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

NCT ID: NCT04520945

Last Updated: 2020-08-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-31
• Study Completion Date: 2022-09-30

Brief Summary

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.

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Chondrogen

Intervention Type: BIOLOGICAL

Mesenchymal stem cell-derived from umbilical cord Wharton Jelly and hyaluronic acid

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Consist of saline and hyaluronic acid

Interventions

Chondrogen

Mesenchymal stem cell-derived from umbilical cord Wharton Jelly and hyaluronic acid

Intervention Type: BIOLOGICAL

Placebo

Consist of saline and hyaluronic acid

Intervention Type: BIOLOGICAL

Other Intervention Names

Mesenchymal Stem Cell

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Meluha Life Sciences SDN BHD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Badrul Akmal Hisham, MBBS

Role: PRINCIPAL_INVESTIGATOR

PPUKM

Locations

Department of Orthopedic & Traumatology, Faculty of Medicine, Hospital Canselor Tuanku Mukhriz, UKM Medical Centre, Jalan Yaacob Latiff, Bandar Tun Razak, Cheras, 56000 Kuala Lumpur.

Cheras, Kuala Lumpur, Malaysia

Countries

Malaysia

Central Contacts

Prakash Nathan, MBA

Role: CONTACT

research@meluhalifesciences.com

03-88902968

Raisah Hadi, MSC

Role: CONTACT

research@meluhalifesciences.com

03-88902968 ext. 105

Facility Contacts

Badrul Akmal Hisham Md. Yusoff, MBBS

Role: primary

badrul.akmal.hisham.md.yusof@ppukm.ukm.edu.my

012-5196119

Other Identifiers

Chondrogen

Identifier Type: -

Identifier Source: org_study_id