Osteoarthritis, KneePhase 2NCT05016011
Efficacy of Allogeneic UCMSCs for Treating Large Defects Knee Injury
A Phase 2 study testing Human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) and Marrow cellution in people with Osteoarthritis, Knee, run by Cytopeutics Sdn. Bhd. at 1 site in Malaysia.
Trial summary
In terms of the surgical treatment of the cartilage injury, various techniques and ways are created to repair or regenerate articular surface of synovial joint following traumatic damage or degeneration of the cartilage. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) and Marrow cellution
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jul 2020to 21 Mar 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged between 18 and 65 years.
- Patients diagnosed to have ICRS Grade 3 or 4 cartilage lesions based on the MRI scans of the affected knee.
- Presence of knee swelling, pain, stiffness, or knee mechanical symptoms resulting from cartilage lesions.
- All subjects must also satisfy at least 1 of the following inclusion criteria.
- Isolated knee articular cartilage lesion (single lesion) estimated to be ≥1.0 cm2 as demonstrated on MRI scanning.
- Multiple knee articular cartilage lesions (multiple lesions) with at least 1 lesion estimated to be ≥1.0 cm2 as demonstrated on MRI scanning.
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- Bipolar cartilage defects demonstrated on MRI scanning with at least 1 articular surface lesion to be ≥1.0 cm2.
- One or more cartilage defects involving the patella-femoral joint as demonstrated on MRI scanning with at least 1 lesion ≥1.0 cm2.
- One or more cartilage defects involving the tibio-femoral joint as demonstrated on MRI scanning with at least 1 lesion ≥1.0 cm2.
- Previously failed cartilage repair procedures (i.e., microfracture, osteochondral autograft transplantation surgery (OATS), ACI) within 6 months.
Who cannot join
- Preoperative flexion deformity greater than 10 degrees.
- Significant cognitive impairment, non-ambulatory status or lower extremities amputation other than toes, serious illness or medication affecting operative risk or wound healing (e.g., steroid intake, anticoagulation).
- Patient with high co-morbidity
- Higher risk for postsurgical (e.g., bleeding disorder or taking anticoagulants except low-dose aspirin) or postsurgical infection (e.g., taking immune-suppressants, have a severe infection or a history of serious infection).
- Significant peripheral vascular disease of the lower limbs as indicated by absent or substantially reduced dorsalis pedis or posterior tibial pulses.
- Contraindications to sub-chondral drilling surgery.
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- Women who are pregnant or who are not able to use contraceptives
- Known hypersensitivity (allergy) to hyaluronate or antibodies used for postsurgical prophylaxis.
- Infections or skin disease affecting the area of the injection site or joint.
- Intra-articular injections of hyaluronic acid in the target knee within the past 6 months before screening.
- Intra-articular injections of corticosteroids in the target knee within the past 3 months before screening.
- In the opinion of the investigators, the subjects have difficulty understanding or complying with the protocol procedures or requirements including follow up.
- In the opinion of the investigators, the subject has any medical, psychiatric, or other condition for which the study would pose particular safety risks and/or unfavorably affect the risk-benefit balance of participation.
- Presence of metallic implants, clips, or devices in the brain, eye, or spinal canal or implanted devices that are magnetically programmed that may affect the ability to perform MRI MOCART scoring.
- Significant knee malalignment, varus or valgus deformity with more than 10 degrees, or instability associated with ligamentous knee injury.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Hospital Canselor Tuanku Muhriz Universiti Kebangsaan Malaysia (HCTM-UKM)
Bandar Tun Razak, Kuala Lumpur, 56000
About this study
Official title: Phase IIb Study Assessing the Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells for Knee Cartilage Injury
In terms of the surgical treatment of the cartilage injury, various techniques and ways are created to repair or regenerate articular surface of synovial joint following traumatic damage or degeneration of the cartilage. The option for surgical treatments based on the size and depth of the cartilage knee injury may include knee debridement, radiofrequency, drilling, microfracture, mosaicplasty, allogenic osteochondral transplantation and autologous chondrocyte transplantation. The first two techniques mentioned have been used in treating the cartilage knee injury involving the partial defects meanwhile the latter techniques have been used for Grade III and IV cartilage defects based on ICRS. However, most of the surgical options up only provide more of Type I collagen rather than Type II collagen. The available treatments are more symptomatic rather than preventive or regenerative. Stem cell has big potential in this area where it has ability to differentiate to cartilage. As allogeneic umbilical cord blood MSCs are readily available and can be administered immediately, this study therefore aims to prove the efficacy of allogeneic umbilical cord-derived mesenchymal stem cells (UC-MSCs) for treating large defects knee injury.
The study is a prospective, randomized controlled, open label, phase IIb clinical trial, involving 50 patients with large defects of cartilage injury for follow-up duration of 24 months. Patients will be assigned into 2 arms; Arm A - 25 subjects will receive Chondrocell-EX (UC-MSCs) and Arm B - 25 subject will receive marrow cellution. All patients will undergo debridement prior to receiving their assigned treatment. The patients will be assessed on KOOS, IKDC, VAS and MRI.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Human umbilical cord-derived mesenchymal stem cells (hUC-MSCs), Marrow cellution
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human umbilical cord-derived mesenchymal stem cells (hUC-MSCs)Biological
Also called Chondrocell-EX
Human umbilical cord-derived mesenchymal stem cells
Marrow cellutionProcedure or surgery
Patients will undergo marrow cellution surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| Human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) | Experimental | Patients will receive 25 x 10^6 of human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) with standard treatment. Receives: Biological: Human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) |
| Marrow cellution (standard treatment) | Active comparator | Patients will undergo marrow cellution surgical procedure. Receives: Procedure: Marrow cellution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recording of Adverse Events and Serious Adverse Events
Measured: 24 months
International Knee Documentation Committee (IKDC) score
Measured: 24 months
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Measured: 24 months
Visual Analog Score (VAS)
Measured: 24 months
Immunohistochemistry (IHC)
IHC staining for generated cartilage
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 posted23 Aug 2021
- Study start1 Jul 2020
- Primary completion21 Mar 2022
- Study completion21 Mar 2022
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
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytopeutics Sdn. Bhd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universiti Kebangsaan Malaysia Medical Centre
- Responsible party
- Sponsor
- Investigators
- Badrul Akmal Hisham Md Yusoff, Principal investigator, Hospital Canselor Tuanku Muhriz Universiti Kebangsaan Malaysia (HCTM-UKM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05016011
- Sponsor's protocol ID
- POD0032/CP/R
- Status last verified
- Jan 2024
- First submitted
- 15 Nov 2020
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- 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 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIb Study Assessing the Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells for Knee Cartilage Injury
- ClinicalTrials.gov ID
- NCT05016011
- Acronym / sponsor ID
- POD0032/CP/R
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Cytopeutics Sdn. Bhd.Industry (pharma, biotech, devices)
- Collaborators
- Universiti Kebangsaan Malaysia Medical Centre
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 21 Mar 2022 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 23 Aug 2021 (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.
In terms of the surgical treatment of the cartilage injury, various techniques and ways are created to repair or regenerate articular surface of synovial joint following traumatic damage or degeneration of the cartilage. The option for surgical treatments based on the size and depth of the cartilage knee injury may include knee debridement, radiofrequency, drilling, microfracture, mosaicplasty, allogenic osteochondral transplantation and autologous chondrocyte transplantation. The first two techniques mentioned have been used in treating the cartilage knee injury involving the partial defects meanwhile the latter techniques have been used for Grade III and IV cartilage defects based on ICRS. However, most of the surgical options up only provide more of Type I collagen rather than Type II collagen. The available treatments are more symptomatic rather than preventive or regenerative. Stem cell has big potential in this area where it has ability to differentiate to cartilage. As allogeneic umbilical cord blood MSCs are readily available and can be administered immediately, this study therefore aims to prove the efficacy of allogeneic umbilical cord-derived mesenchymal stem cells (UC-MSCs) for treating large defects knee injury.
The study is a prospective, randomized controlled, open label, phase IIb clinical trial, involving 50 patients with large defects of cartilage injury for follow-up duration of 24 months. Patients will be assigned into 2 arms; Arm A - 25 subjects will receive Chondrocell-EX (UC-MSCs) and Arm B - 25 subject will receive marrow cellution. All patients will undergo debridement prior to receiving their assigned treatment. The patients will be assessed on KOOS, IKDC, VAS and MRI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) | Experimental | Biological: Human umbilical cord-derived mesenchymal stem cells (hUC-MSCs)Patients will receive 25 x 10^6 of human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) with standard treatment. |
| Marrow cellution (standard treatment) | Active comparator | Procedure: Marrow cellutionPatients will undergo marrow cellution surgical procedure. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men and women aged between 18 and 65 years.
- Patients diagnosed to have ICRS Grade 3 or 4 cartilage lesions based on the MRI scans of the affected knee.
- Presence of knee swelling, pain, stiffness, or knee mechanical symptoms resulting from cartilage lesions.
- All subjects must also satisfy at least 1 of the following inclusion criteria.
Key exclusion criteria (15 listed)
- Preoperative flexion deformity greater than 10 degrees.
- Significant cognitive impairment, non-ambulatory status or lower extremities amputation other than toes, serious illness or medication affecting operative risk or wound healing (e.g., steroid intake, anticoagulation).
- Patient with high co-morbidity
- Higher risk for postsurgical (e.g., bleeding disorder or taking anticoagulants except low-dose aspirin) or postsurgical infection (e.g., taking immune-suppressants, have a severe infection or a history of serious infection).
- Significant peripheral vascular disease of the lower limbs as indicated by absent or substantially reduced dorsalis pedis or posterior tibial pulses.
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 |
|---|---|---|
| Human umbilical cord-derived mesenchymal stem cells (hUC-MSCs)Also: Chondrocell-EXHuman umbilical cord-derived mesenchymal stem cells | Biological | Human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) |
| Marrow cellutionPatients will undergo marrow cellution surgical procedure. | Procedure or surgery | Marrow cellution (standard treatment) |
Primary outcome
Recording of Adverse Events and Serious Adverse Events
Time frame: 24 months
International Knee Documentation Committee (IKDC) score
Time frame: 24 months
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 24 months
Visual Analog Score (VAS)
Time frame: 24 months
Immunohistochemistry (IHC)
Time frame: 12 months
IHC staining for generated cartilage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- 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 Md Yusoff principal investigator
Hospital Canselor Tuanku Muhriz Universiti Kebangsaan Malaysia (HCTM-UKM)
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 Human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) and Marrow cellution in people with Osteoarthritis, Knee, run by Cytopeutics 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 10 inclusion and 15 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: finished, as of the sponsor's last update on 3 Jan 2024. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recording of Adverse Events and Serious Adverse Events (time frame: 24 months). The study lists 5 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 3 Jan 2024.