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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chondrogen | Biological | Mesenchymal stem cell-derived from umbilical cord Wharton Jelly and hyaluronic acid |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prakash Nathan, MBA | Contact | 03-88902968 | research@meluhalifesciences.com | |
| Raisah Hadi, MSC | Contact | 03-88902968 | 105 | research@meluhalifesciences.com |
| Name | Affiliation | Role |
|---|---|---|
| Badrul Akmal Hisham, MBBS | PPUKM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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100 patients will be selected from 2 different study sites. Each study site comprises 50 patients.
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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.
|
| Placebo | Biological | Consist of saline and hyaluronic acid |
|
| 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 |
|
| D012216 |
| Rheumatic Diseases |