Osteoarthritis, KneePhase 2NCT04520945
Phase 2B Clinical Study of Chondrogen for Treatment of Knee Osteoarthritis
A Phase 2 study testing Chondrogen in people with Osteoarthritis, Knee, run by Meluha Life Sciences SDN BHD at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Chondrogen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteMalaysia
- Study dates
- 31 Oct 2020to 30 Sep 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
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
Badrul Akmal Hisham Md. Yusoff, MBBS, 012-5196119, badrul.akmal.hisham.md.yusof@ppukm.ukm.edu.my
Badrul Akmal Hisham Md. Yusoff, MBBS
About this study
Official title: 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.
Read the 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
- Being tested
- Chondrogen, Placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChondrogenBiological
Also called Mesenchymal Stem Cell
Mesenchymal stem cell-derived from umbilical cord Wharton Jelly and hyaluronic acid
PlaceboBiological
Consist of saline and hyaluronic acid
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score
Change from Baseline in Visual Analogue Scale (VAS)
Measured: 12 months
WOMAC score
Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index Score (WOMAC)
Measured: 12 months
IKDC score
Change from Baseline in knee function change and improvement (IKDC)
Measured: 12 months
KOOS score
Change from Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Measured: 12 months
Secondary outcomes (3)
PROMIS29 score
Change in Patient-Reported Outcomes Measurement Information System (PROMIS29) scores
Measured: 12 months
Kellegren-Lawrence grading
Number of participants evaluated by X-ray and MRI of knee OA from baseline Kellegren-Lawrence grading system.
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start31 Oct 2020 (estimated)
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 100 patients will be selected from 2 different study sites. Each study site comprises 50 patients.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meluha Life Sciences SDN BHD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Badrul Akmal Hisham, MBBS, Principal investigator, PPUKM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04520945
- Sponsor's protocol ID
- Chondrogen
- Status last verified
- Aug 2020
- First submitted
- 17 Aug 2020
- Last updated
- 20 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2B: Randomized Double-Blinded Clinical Study of Chondrogen for Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04520945
- Acronym / sponsor ID
- Chondrogen
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meluha Life Sciences SDN BHDIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2020 (estimated)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 20 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 100 patients will be selected from 2 different study sites. Each study site comprises 50 patients.
| Arm | Type | Receives |
|---|---|---|
| Active Participant of Phase 2B Clinical Study Chondrogen | Active comparator | Biological: Chondrogen50 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 | Biological: Placebo50 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. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChondrogenAlso: Mesenchymal Stem CellMesenchymal stem cell-derived from umbilical cord Wharton Jelly and hyaluronic acid | Biological | Active Participant of Phase 2B Clinical Study Chondrogen |
| PlaceboConsist of saline and hyaluronic acid | Biological | Placebo Participant of Phase 2B Clinical Study Chondrogen |
Primary outcome
VAS score
Time frame: 12 months
Change from Baseline in Visual Analogue Scale (VAS)
WOMAC score
Time frame: 12 months
Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index Score (WOMAC)
IKDC score
Time frame: 12 months
Change from Baseline in knee function change and improvement (IKDC)
KOOS score
Time frame: 12 months
Change from Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS)
3 secondary outcomes
PROMIS29 score
Time frame: 12 months
Kellegren-Lawrence grading
Time frame: 12 months
Interleukins
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Badrul Akmal Hisham, MBBS principal investigator
PPUKM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chondrogen in people with Osteoarthritis, Knee, run by Meluha Life Sciences SDN BHD at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Prakash Nathan, MBA (03-88902968, research@meluhalifesciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS score (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2020.