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

NCT04520945 | Unknown Phase 2

• 1 other identifier: Chondrogen
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• PROMIS29 score

  12 months

• Kellegren-Lawrence grading

  12 months

• Interleukins

  12 months

Study Arms (2)

Active Participant of Phase 2B Clinical Study Chondrogen

ACTIVE COMPARATOR

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

Placebo Participant of Phase 2B Clinical Study Chondrogen

PLACEBO COMPARATOR

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

Interventions

Chondrogen BIOLOGICAL

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

Also known as: Mesenchymal Stem Cell

Active Participant of Phase 2B Clinical Study Chondrogen

Placebo BIOLOGICAL

Consist of saline and hyaluronic acid

Placebo Participant of Phase 2B Clinical Study Chondrogen

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Meluha Life Sciences SDN BHD: lead

Study Sites (1)

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, 56000, Malaysia

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Badrul Akmal Hisham, MBBS

  PPUKM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prakash Nathan, MBA

CONTACT

03-88902968; research@meluhalifesciences.com

Raisah Hadi, MSC

CONTACT

03-88902968; research@meluhalifesciences.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The outcomes assessor will help to screen the participants and send them to the clinical investigators for further medical screening. The participant's personal details will be private and confidential to the outcomes assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 100 patients will be selected from 2 different study sites. Each study site comprises 50 patients.

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 20, 2020
• Study Start: October 31, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2022
• Last Updated: August 20, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)