Osteoarthritis of Knee JointPhase 2NCT01448434
Allogeneic Mesenchymal Stem Cells for Osteoarthritis
A Phase 2 study testing Ex- vivo cultured adult allogeneic MSCs and Plasmalyte-A in people with Osteoarthritis of Knee Joint, run by Stempeutics Research Pvt Ltd at 4 sites in Malaysia.
Trial summary
This study is designed to know the safety and efficacy of 2 different doses of mesenchymal stem cells in patients suffering from osteoarthritis of knee joint. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Osteoarthritis of Knee Joint
- What is being tested?
- Ex- vivo cultured adult allogeneic MSCs and Plasmalyte-A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 4 sitesMalaysia
- Study dates
- Sep 2011to Sep 2013
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females in the age 20 - 70 years (both inclusive)
- Radiographic evidence of grade 2 to 3 osteoarthritis based on the Kellgren and Lawrence radiographic entry criteria.
- History of primary idiopathic osteoarthritis of the knee characterized by pain which requires intake of analgesics.
- Self-reported difficulty in at least one of the following activities attributed to knee pain: lifting and carrying groceries, walking 400 metres, getting in and out of a chair, or going up and down stairs.
- Patients who have been on stable medication for the past three months.
- Patients who have not received intra articular steroids or hyaluronan within the last three months.
- Female patients of childbearing age must be willing to use accepted methods of contraception during the course of the study
- Ability to provide written informed consent.
Who cannot join
- Prior or ongoing medical conditions (e.g., concomitant illness, psychiatric condition, alcoholism, drug abuse), medical history, physical findings, ECG findings, or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the subject, makes it unlikely that the course of treatment or follow-up would be completed, or could impair the assessment of study results.
- History of surgery, including arthroscopy, or major trauma to the study joint in the previous 12 months
- Signs of active study joint inflammation including redness, warmth, and/or, if qualifying with osteoarthritis of the knee, a large, bulging effusion of the study knee joint with the loss of normal contour of the joint at the screening visit or at the baseline examination
- Infections in or around the knee.
- Patients awaiting a replacement knee or hip joint
- Patients with other conditions that cause pain
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- Significantly incapacitated or disabled and would be categorized as ACR Functional Class IV (largely or wholly incapacitated), or unable to walk without assistive devices
- Patients with other known rheumatic or inflammatory disease such as rheumatoid arthritis
- Other pathologic lesions on x-rays of knee
- Positive hepatitis B surface antigen, hepatitis C antibody test, Anti human immunodeficiency virus (HIV) antibody test, or VDRL
- History of Bleeding disorders
- Known hypersensitivity to Hyaluronan products or animal sera
- For women of child-bearing potential: positive pregnancy test or lactating
Trial locations and contacts
4 sites in 1 country.
Malaysia4 sites
Pantai Cheras Medical Centre
Kuala Lumpur, Kuala Lumpur, 56100
Serdang Hospital
Kuala Lumpur, Selangor, 43300
KPJ Ampang Puteri Specialist Hospital
Kuala Lumpur, Selangor, 68000
Selayang Hospital
Kuala Lumpur, Selangor, 68100
About this study
Official title: A Randomized, Double Blind, Multicentric, Placebo Controlled, Phase -II Study Assessing the Safety and Efficacy of Intraarticular Ex-vivo Cultured Adult Allogeneic Mesenchymal Stem Cells in Patients With Osteoarthritis of Knee
This study is designed to know the safety and efficacy of 2 different doses of mesenchymal stem cells in patients suffering from osteoarthritis of knee joint.
- Conditions
- Osteoarthritis of Knee Joint
- Being tested
- Ex- vivo cultured adult allogeneic MSCs, Plasmalyte-A
- Keywords
- Osteoarthritis, Knee, Stem cell, MSC
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ex- vivo cultured adult allogeneic MSCsBiological
Single intraarticular dose of allogeneic MSCs suspended in 2ml Plasmalyte followed by 2ml of Hyaluronan
Plasmalyte-ABiological
Single intraarticular dose of 2ml Plasmalyte followed by 2ml Hyaluronan
| Study group | Role | What they receive |
|---|---|---|
| Ex- vivo cultured adult allogeneic MSCs | Experimental | Single intraarticular dose of allogeneic MSCs Receives: Biological: Ex- vivo cultured adult allogeneic MSCs |
| Plasmalyte-A | Placebo comparator | Single intraarticular dose of 2ml Plasmalyte Receives: Biological: Plasmalyte-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of patients with adverse events as a measure of safety and tolerability
- Safety evaluation will include assessment of physical examination, periodic monitoring of vital signs (heart rate, respiratory rate, blood pressure and temperature), clinical laboratory investigations (including haematology, serum chemistry, LFT, urine-analysis) and 12-lead ECG recording.
- Tolerability: Adverse events monitored using information volunteered by the patients and as observed by the PI will be summarized descriptively by total number of AE(s) and compared between the study arms.
Measured: 1 year
Secondary outcomes (8)
Change from baseline in the WOMAC OA (Western Ontario and McMaster Universities Osteoarthritis) Index -pain subscale score
Measured: 1 Year
Change from baseline in WOMAC OA stiffness index
Measured: 1 Year
Change from baseline in WOMAC OA composite index
Measured: 1 Year
Change from baseline in ICOAP (Intermittent and Constant Osteoarthritis Pain)
Measured: 1 Year
Change from baseline in radiographic (X-ray) findings of knee
Measured: 1 Year
Change from baseline in the WORMS score of knee using MRI
Measured: 1 Year
Change from baseline in arthritis pain scores on the visual analogue scale
Measured: 1 Year
Reduction in the intake of analgesic tablets from baseline
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of Knee JointStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stempeutics Research Pvt Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stempeutics Research Malaysia SDN BHD
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. Muhammad Ali Noor Muhd Abdul Ghani, FRCS, Principal investigator, KPJ Ampang Puteri Specialist HospitalDr. Ahmad Hisham Abd. Rashid, MD., MS, Principal investigator, Clinical Research Centre Hospital SerdangDr. Suntharalingam Subramaniam, FRCS, Principal investigator, Pantai Cheras Medical CentreDato' Dr. Ramli Baba, MS, Principal investigator, Selayang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448434
- Sponsor's protocol ID
- SRM/OA/10-11/001
- Status last verified
- May 2016
- First submitted
- 20 Sep 2011
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Multicentric, Placebo Controlled, Phase -II Study Assessing the Safety and Efficacy of Intraarticular Ex-vivo Cultured Adult Allogeneic Mesenchymal Stem Cells in Patients With Osteoarthritis of Knee
- ClinicalTrials.gov ID
- NCT01448434
- Acronym / sponsor ID
- SRM/OA/10-11/001
- Conditions
- Osteoarthritis of Knee Joint
- Keywords
- Osteoarthritis, Knee, Stem cell, MSC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Stempeutics Research Pvt LtdIndustry (pharma, biotech, devices)
- Collaborators
- Stempeutics Research Malaysia SDN BHD
- Study start
- Sep 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 7 Oct 2011 (estimated)
- 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.
This study is designed to know the safety and efficacy of 2 different doses of mesenchymal stem cells in patients suffering from osteoarthritis of knee joint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ex- vivo cultured adult allogeneic MSCs | Experimental | Biological: Ex- vivo cultured adult allogeneic MSCsSingle intraarticular dose of allogeneic MSCs |
| Plasmalyte-A | Placebo comparator | Biological: Plasmalyte-ASingle intraarticular dose of 2ml Plasmalyte |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males or females in the age 20 - 70 years (both inclusive)
- Radiographic evidence of grade 2 to 3 osteoarthritis based on the Kellgren and Lawrence radiographic entry criteria.
- History of primary idiopathic osteoarthritis of the knee characterized by pain which requires intake of analgesics.
- Self-reported difficulty in at least one of the following activities attributed to knee pain: lifting and carrying groceries, walking 400 metres, getting in and out of a chair, or going up and down stairs.
- Patients who have been on stable medication for the past three months.
Key exclusion criteria (13 listed)
- Prior or ongoing medical conditions (e.g., concomitant illness, psychiatric condition, alcoholism, drug abuse), medical history, physical findings, ECG findings, or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the subject, makes it unlikely that the course of treatment or follow-up would be completed, or could impair the assessment of study results.
- History of surgery, including arthroscopy, or major trauma to the study joint in the previous 12 months
- Signs of active study joint inflammation including redness, warmth, and/or, if qualifying with osteoarthritis of the knee, a large, bulging effusion of the study knee joint with the loss of normal contour of the joint at the screening visit or at the baseline examination
- Infections in or around the knee.
- Patients awaiting a replacement knee or hip joint
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 |
|---|---|---|
| Ex- vivo cultured adult allogeneic MSCsSingle intraarticular dose of allogeneic MSCs suspended in 2ml Plasmalyte followed by 2ml of Hyaluronan | Biological | Ex- vivo cultured adult allogeneic MSCs |
| Plasmalyte-ASingle intraarticular dose of 2ml Plasmalyte followed by 2ml Hyaluronan | Biological | Plasmalyte-A |
Primary outcome
Number and percentage of patients with adverse events as a measure of safety and tolerability
Time frame: 1 year
* Safety evaluation will include assessment of physical examination, periodic monitoring of vital signs (heart rate, respiratory rate, blood pressure and temperature), clinical laboratory investigations (including haematology, serum chemistry, LFT, urine-analysis) and 12-lead ECG recording. * Tolerability: Adverse events monitored using information volunteered by the patients and as observed by the PI will be summarized descriptively by total number of AE(s) and compared between the study arms.
8 secondary outcomes
Change from baseline in the WOMAC OA (Western Ontario and McMaster Universities Osteoarthritis) Index -pain subscale score
Time frame: 1 Year
Change from baseline in WOMAC OA stiffness index
Time frame: 1 Year
Change from baseline in WOMAC OA composite index
Time frame: 1 Year
Change from baseline in ICOAP (Intermittent and Constant Osteoarthritis Pain)
Time frame: 1 Year
Change from baseline in radiographic (X-ray) findings of knee
Time frame: 1 Year
Change from baseline in the WORMS score of knee using MRI
Time frame: 1 Year
Change from baseline in arthritis pain scores on the visual analogue scale
Time frame: 1 Year
Reduction in the intake of analgesic tablets from baseline
Time frame: 1 Year
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 12 May 2016.
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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.
Prof. Dr. Muhammad Ali Noor Muhd Abdul Ghani, FRCS principal investigator
KPJ Ampang Puteri Specialist Hospital
Dr. Ahmad Hisham Abd. Rashid, MD., MS principal investigator
Clinical Research Centre Hospital Serdang
Dr. Suntharalingam Subramaniam, FRCS principal investigator
Pantai Cheras Medical Centre
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ex- vivo cultured adult allogeneic MSCs and Plasmalyte-A in people with Osteoarthritis of Knee Joint, run by Stempeutics Research Pvt Ltd at 4 sites 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 8 inclusion and 13 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 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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?
Number and percentage of patients with adverse events as a measure of safety and tolerability (time frame: 1 year). 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 12 May 2016.