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

Primary Purpose

Osteoarthritis, Knee

Status
Unknown status
Phase
Phase 2
Locations
Malaysia
Study Type
Interventional
Intervention
Chondrogen
Placebo
Sponsored by
Meluha Life Sciences SDN BHD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / 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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active Participant of Phase 2B Clinical Study Chondrogen

Placebo Participant of Phase 2B Clinical Study Chondrogen

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

PROMIS29 score
Change in Patient-Reported Outcomes Measurement Information System (PROMIS29) scores
Kellegren-Lawrence grading
Number of participants evaluated by X-ray and MRI of knee OA from baseline Kellegren-Lawrence grading system.
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

Full Information

First Posted
August 17, 2020
Last Updated
August 17, 2020
Sponsor
Meluha Life Sciences SDN BHD
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1. Study Identification

Unique Protocol Identification Number
NCT04520945
Brief Title
Phase 2B Clinical Study of Chondrogen for Treatment of Knee Osteoarthritis
Official Title
Phase 2B: Randomized Double-Blinded Clinical Study of Chondrogen for Treatment of Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 31, 2020 (Anticipated)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meluha Life Sciences SDN BHD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
100 patients will be selected from 2 different study sites. Each study site comprises 50 patients.
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Participant of Phase 2B Clinical Study Chondrogen
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo Participant of Phase 2B Clinical Study Chondrogen
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Chondrogen
Other Intervention Name(s)
Mesenchymal Stem Cell
Intervention Description
Mesenchymal stem cell-derived from umbilical cord Wharton Jelly and hyaluronic acid
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Consist of saline and hyaluronic acid
Primary Outcome Measure Information:
Title
VAS score
Description
Change from Baseline in Visual Analogue Scale (VAS)
Time Frame
12 months
Title
WOMAC score
Description
Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index Score (WOMAC)
Time Frame
12 months
Title
IKDC score
Description
Change from Baseline in knee function change and improvement (IKDC)
Time Frame
12 months
Title
KOOS score
Description
Change from Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
PROMIS29 score
Description
Change in Patient-Reported Outcomes Measurement Information System (PROMIS29) scores
Time Frame
12 months
Title
Kellegren-Lawrence grading
Description
Number of participants evaluated by X-ray and MRI of knee OA from baseline Kellegren-Lawrence grading system.
Time Frame
12 months
Title
Interleukins
Description
Changes of interleukins (IL-1b, IL-6, PGE-2, TGF-b, TNF-a, IGF-1) of articular cavity fluid from baseline to week 12
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Prakash Nathan, MBA
Phone
03-88902968
Email
research@meluhalifesciences.com
First Name & Middle Initial & Last Name or Official Title & Degree
Raisah Hadi, MSC
Phone
03-88902968
Ext
105
Email
research@meluhalifesciences.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Badrul Akmal Hisham, MBBS
Organizational Affiliation
PPUKM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Orthopedic & Traumatology, Faculty of Medicine, Hospital Canselor Tuanku Mukhriz, UKM Medical Centre, Jalan Yaacob Latiff, Bandar Tun Razak, Cheras, 56000 Kuala Lumpur.
City
Cheras
State/Province
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Badrul Akmal Hisham Md. Yusoff, MBBS
Phone
012-5196119
Email
badrul.akmal.hisham.md.yusof@ppukm.ukm.edu.my
First Name & Middle Initial & Last Name & Degree
Badrul Akmal Hisham Md. Yusoff, MBBS

12. IPD Sharing Statement

Plan to Share IPD
No

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

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