Knee OsteoarthritisPhase 1NCT00850187
Autologous Transplantation of Mesenchymal Stem Cells (MSCs) and Scaffold in Full-thickness Articular Cartilage
A Phase 1 study testing Bone marrow derived mesenchymal stem cells in people with Knee Osteoarthritis, run by Royan Institute at 2 sites in Iran.
Trial summary
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Bone Marrow Mesenchymal stem cells (MSCs) mixed with collagen I scaffold in patient with Knee cartilage defects and osteoarthritis Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Bone marrow derived mesenchymal stem cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesIran
- Study dates
- Aug 2008to Dec 2010
- Phase
- Phase 1
- 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 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 45 to 60, inclusive
- Normal axial alignment
- Stable knee-previous ligament reconstruction, if stable
- Intact articular cartilage in posterior meniscal weight-bearing zone
- Ability to understand and willingness tosign consent from
- O.C.D or OA calgran classification II,III
Who cannot join
- Pregnant or lactating
- Inflammatory arthritis
- Oral steriod, methotrexate
- Unable to follow post-operative exercise regimen or return for evaluations
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Treatment of Full-thickness Articular Cartilage Defects in the Knee of Patients With Autologous Bone-marrow Mesenchymal Stem Cells and Scaffold
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Bone Marrow Mesenchymal stem cells (MSCs) mixed with collagen I scaffold in patient with Knee cartilage defects and osteoarthritis
Read the detailed description
Articular cartilage defects have a weak potential for self-repair because of the reduced mitotic capacity of chondrocytes in vivo. Because some patients with articular cartilage defects may progress to osteoarthritis, such defects need to be repaired even though their exact natural course remains obscure. Traditional methods for repair, such as micro fracture, perforations, abrasion arthroplasty, have not produced consistent satisfactory long term clinical results. Transplantation of autologous bone marrow MSCs expanded in culture would be a promising approach in the repair of articular cartilage defects in human osteoarthritic knees. This method is clinically straightforward to perform because autologous cells can be readily harvested and expanded in culture without losing their capacity to differentiate into chondrocytes. The purpose of this study was to evaluate the clinical results obtained with autologous MSCs expanded in culture for the treatment of full-thickness chondral defects in human knee.
- Conditions
- Knee Osteoarthritis
- Being tested
- Bone marrow derived mesenchymal stem cells
- Keywords
- Knee cartilage diseases
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marrow derived mesenchymal stem cellsBiological
Bone Marrow Aspiration A total volume of 300 ml bone marrow will be aspirated from the iliac crest and are cultured for mesenchymal stem cells
| Study group | Role | What they receive |
|---|---|---|
| Bone marrow mesenchymal stem cells | Experimental | Not described Receives: Biological: Bone marrow derived mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee cartilage defects
Measured: 12 months
Secondary outcomes (1)
pain
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 posted24 Feb 2009 (estimated)
- Study startAug 2008
- Primary completionJul 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Collaborators
- Tehran University of Medical Sciences
- Responsible party
- Sponsor
- Investigators
- Hamid gourabi, PhD, Study chair, ChiefMohamadreza Baghaban Eslaminejad, PhD, Study director, Scientific BoardLeila Taghiyar, Msc, Principal investigator, Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00850187
- Sponsor's protocol ID
- Royan - Bone - 001
- Status last verified
- Apr 2010
- First submitted
- 21 Feb 2009
- Last updated
- 5 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Full-thickness Articular Cartilage Defects in the Knee of Patients With Autologous Bone-marrow Mesenchymal Stem Cells and Scaffold
- ClinicalTrials.gov ID
- NCT00850187
- Acronym / sponsor ID
- Royan - Bone - 001
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee cartilage diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Collaborators
- Tehran University of Medical Sciences
- Study start
- Aug 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 24 Feb 2009 (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.
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Bone Marrow Mesenchymal stem cells (MSCs) mixed with collagen I scaffold in patient with Knee cartilage defects and osteoarthritis
Detailed description
Articular cartilage defects have a weak potential for self-repair because of the reduced mitotic capacity of chondrocytes in vivo. Because some patients with articular cartilage defects may progress to osteoarthritis, such defects need to be repaired even though their exact natural course remains obscure. Traditional methods for repair, such as micro fracture, perforations, abrasion arthroplasty, have not produced consistent satisfactory long term clinical results. Transplantation of autologous bone marrow MSCs expanded in culture would be a promising approach in the repair of articular cartilage defects in human osteoarthritic knees. This method is clinically straightforward to perform because autologous cells can be readily harvested and expanded in culture without losing their capacity to differentiate into chondrocytes. The purpose of this study was to evaluate the clinical results obtained with autologous MSCs expanded in culture for the treatment of full-thickness chondral defects in human knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bone marrow mesenchymal stem cells | Experimental | Biological: Bone marrow derived mesenchymal stem cells |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 45 to 60, inclusive
- Normal axial alignment
- Stable knee-previous ligament reconstruction, if stable
- Intact articular cartilage in posterior meniscal weight-bearing zone
- Ability to understand and willingness tosign consent from
Key exclusion criteria (4 listed)
- Pregnant or lactating
- Inflammatory arthritis
- Oral steriod, methotrexate
- Unable to follow post-operative exercise regimen or return for evaluations
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 |
|---|---|---|
| Bone marrow derived mesenchymal stem cellsBone Marrow Aspiration A total volume of 300 ml bone marrow will be aspirated from the iliac crest and are cultured for mesenchymal stem cells | Biological | Bone marrow mesenchymal stem cells |
Primary outcome
Knee cartilage defects
Time frame: 12 months
1 secondary outcome
pain
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 5 Jan 2012.
- Related InfoLink provided by the sponsor.
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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.
Hamid gourabi, PhD study chair
Chief
Mohamadreza Baghaban Eslaminejad, PhD study director
Scientific Board
Leila Taghiyar, Msc principal investigator
Researcher
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bone marrow derived mesenchymal stem cells in people with Knee Osteoarthritis, run by Royan Institute at 2 sites in Iran.
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 6 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 5 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Knee cartilage defects (time frame: 12 months). 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 5 Jan 2012.