Articular Cartilage Disorder of KneePhase 2NCT02118519
Mesenchymal Stem Cells in Knee Cartilage Injuries
A Phase 2 study testing Autologous Mesenchymal Stem Cells in people with Articular Cartilage Disorder of Knee and Osteoarthritis, Knee, run by University of Jordan at 1 site in Jordan.
Trial summary
Induction of autologous repair chondrogenesis to regenerate injured articular cartilage using bone marrow mesenchymal stem cells (MSCs) after in vitro expansion under restricted culturing conditions. Read more about this study
- Who is it for?
- Ages 40 to 68 years
- Conditions the study is for
- Articular Cartilage Disorder of Knee, Osteoarthritis, Knee
- What is being tested?
- Autologous Mesenchymal Stem Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteJordan
- Study dates
- Jan 2014to Aug 2015
- 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 40 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MRI must show moderate/severe articular injury
- Serum collagen II must be above the normal value.
- Lesion site: Femoral and Tibial condyles or patella
- Admission of steroid , NSAID, pain killers must be stopped before 1 month
Who cannot join
- Lesion size
- PT and PTT not within normal value
- Complete blood count ( Hb, PCV, and RBC) not within the normal value
- HIV and Hepatitis Antigens (B and C) detection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Mesenchymal Stem Cells for the Repair of Articular Cartilage Disorder of Knee Using Intra-articular Injection of Mesenchymal Cells Alone or Mesenchymal Cells With Platelet Lysate
Induction of autologous repair chondrogenesis to regenerate injured articular cartilage using bone marrow mesenchymal stem cells (MSCs) after in vitro expansion under restricted culturing conditions.
Read the detailed description
Fourteen patients from both genders, age range 40-68, will be enrolled according to strict inclusion and exclusion criteria, divided into two equal groups based upon receiving autologous MSCs alone, or MSCs supported by platelet lysate through percutaneous injection.
The patients are followed by clinical assessment, laboratory investigations as well as magnetic resonance imaging (MRI) of the injected knee.
The investigators hypothesize that the two groups will give satisfactory clinical outcomes, but the investigators are looking forward to assessing the best product that will activate chondrogenesis and heal cartilaginous injury.
- Being tested
- Autologous Mesenchymal Stem Cells
- Keywords
- Bone marrow derived Mesenchymal Stem Cells, Knee articular cartilage injury, Chondrogenesis, orthopedics
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Mesenchymal Stem CellsBiological
Comparison of clinical outcomes of patients injected by mesenchymal stem cells only with patients injected with mesenchymal stem cells supported by platelet lysate
| Study group | Role | What they receive |
|---|---|---|
| mesenchymal stem cells | Active comparator | Autologous Mesenchymal Stem Cells primed prior to intra articular injection into knees of patients with advanced articular cartilage injury Receives: Biological: Autologous Mesenchymal Stem Cells |
| mesenchymal cells&platelet lysate | Active comparator | Autologous Mesenchymal Stem Cells primed prior to intra articular injection with platelet lysate into knees of patients with advanced articular cartilage injury Receives: Biological: Autologous Mesenchymal Stem Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the therapeutic benefits of the injected Autologous Mesenchymal Stem Cells.
Measured: 12 months
Secondary outcomes (1)
Assessment of the articular cartilage healing in osteoarthritic patients through intra articular injection of Autologus Mesenchymal stem cell with/or without supported product.
For every patient tests would be performed repeated at 6, and 12 months post-injection.
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 posted21 Apr 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Articular Cartilage Disorder of 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatima Jamali, University of Jordan
- Investigators
- Abdallah Awidi, MD, Study director, Cell Therapy CenterMahasen S Najjar, MD, Principal investigator, Jordan University HospitalHiba Khalil, PhD, Principal investigator, Al-Neelain University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118519
- Sponsor's protocol ID
- KneeUJCTC
- Status last verified
- Feb 2016
- First submitted
- 24 Jan 2014
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Al-Najar M, Khalil H, Al-Ajlouni J, Al-Antary E, Hamdan M, Rahmeh R, Alhattab D, Samara O, Yasin M, Abdullah AA, Al-Jabbari E, Hmaid D, Jafar H, Awidi A. Intra-articular injection of expanded autologous bone marrow mesenchymal cells in moderate and severe knee osteoarthritis is safe: a phase I/II study. J Orthop Surg Res. 2017 Dec 12;12(1):190. doi: 10.1186/s13018-017-0689-6.
PubMed 29233163
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Mesenchymal Stem Cells for the Repair of Articular Cartilage Disorder of Knee Using Intra-articular Injection of Mesenchymal Cells Alone or Mesenchymal Cells With Platelet Lysate
- ClinicalTrials.gov ID
- NCT02118519
- Acronym / sponsor ID
- KneeUJCTC
- Keywords
- Bone marrow derived Mesenchymal Stem Cells, Knee articular cartilage injury, Chondrogenesis, orthopedics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 21 Apr 2014 (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.
Induction of autologous repair chondrogenesis to regenerate injured articular cartilage using bone marrow mesenchymal stem cells (MSCs) after in vitro expansion under restricted culturing conditions.
Detailed description
Fourteen patients from both genders, age range 40-68, will be enrolled according to strict inclusion and exclusion criteria, divided into two equal groups based upon receiving autologous MSCs alone, or MSCs supported by platelet lysate through percutaneous injection.
The patients are followed by clinical assessment, laboratory investigations as well as magnetic resonance imaging (MRI) of the injected knee.
The investigators hypothesize that the two groups will give satisfactory clinical outcomes, but the investigators are looking forward to assessing the best product that will activate chondrogenesis and heal cartilaginous injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mesenchymal stem cells | Active comparator | Biological: Autologous Mesenchymal Stem CellsAutologous Mesenchymal Stem Cells primed prior to intra articular injection into knees of patients with advanced articular cartilage injury |
| mesenchymal cells&platelet lysate | Active comparator | Biological: Autologous Mesenchymal Stem CellsAutologous Mesenchymal Stem Cells primed prior to intra articular injection with platelet lysate into knees of patients with advanced articular cartilage injury |
Who may qualify
- Ages
- 40 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- MRI must show moderate/severe articular injury
- Serum collagen II must be above the normal value.
- Lesion site: Femoral and Tibial condyles or patella
- Admission of steroid , NSAID, pain killers must be stopped before 1 month
Key exclusion criteria (4 listed)
- Lesion size
- PT and PTT not within normal value
- Complete blood count ( Hb, PCV, and RBC) not within the normal value
- HIV and Hepatitis Antigens (B and C) detection
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 |
|---|---|---|
| Autologous Mesenchymal Stem CellsComparison of clinical outcomes of patients injected by mesenchymal stem cells only with patients injected with mesenchymal stem cells supported by platelet lysate | Biological | mesenchymal cells&platelet lysate, mesenchymal stem cells |
Primary outcome
Assessing the therapeutic benefits of the injected Autologous Mesenchymal Stem Cells.
Time frame: 12 months
1 secondary outcome
Assessment of the articular cartilage healing in osteoarthritic patients through intra articular injection of Autologus Mesenchymal stem cell with/or without supported product.
Time frame: 12 months
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 24 Feb 2016.
- Derived from this study: PubMed 29233163Al-Najar M, Khalil H, Al-Ajlouni J, Al-Antary E, Hamdan M, Rahmeh R, Alhattab D, Samara O, Yasin M, Abdullah AA, Al-Jabbari E, Hmaid D, Jafar H, Awidi A. Intra-articular injection of expanded autologous bone marrow mesenchymal cells in moderate and severe knee osteoarthritis is safe: a phase I/II study. J Orthop Surg Res. 2017 Dec 12;12(1):190. doi: 10.1186/s13018-017-0689-6.
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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.
Abdallah Awidi, MD study director
Cell Therapy Center
Mahasen S Najjar, MD principal investigator
Jordan University Hospital
Hiba Khalil, PhD principal investigator
Al-Neelain University
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 Autologous Mesenchymal Stem Cells in people with Articular Cartilage Disorder of Knee and Osteoarthritis, Knee, run by University of Jordan at 1 site in Jordan.
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 4 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 24 Feb 2016. 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 Jordan. 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?
Assessing the therapeutic benefits of the injected Autologous Mesenchymal Stem Cells. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02118519, which also lists 1 linked publication.
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 24 Feb 2016.