Osteoarthritis, KneePhase 1/2KDD&MSVNCT01183728
Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stem Cells
A Phase 1/2 study testing Autologous bone marrow mesenchymal stem cells (MSV) in people with Osteoarthritis, Knee and Knee Degenerative Disease, run by Red de Terapia Celular at 2 sites in Spain.
Trial summary
In this prospective study we aim to evaluate the feasibility and safety of the implantation of 40 millions MSV in knees with osteoarthritis of grade II-IV (Kellgren and Lawrence). Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Osteoarthritis, Knee, Knee Degenerative Disease, Knee Osteoarthritis
- What is being tested?
- Autologous bone marrow mesenchymal stem cells (MSV)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesSpain
- Study dates
- May 2010to Sep 2014
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Knee osteoarthritis grade II, III and IV of Kellgren and Lawrence assessed by two observers.
- Chronic knee pain with mechanical characteristics.
- No local or systemic septic process.
- Haematological and biochemical analysis without significant alterations that contraindicate treatment.
- Informed written consent of the patient.
- The patient is able to understand the nature of the study
Who cannot join
- Age over 75 or under 18 years or legally dependent
- Any sign of infection
- Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg, Anti-HCV-Ab), Hepatitis C (Anti-HCV-Ab) and syphilis.
- Congenital or acquired malformation resulting in significant deformity of the knee and leading to problems in application or evaluation of results.
- Overweight expressed as body mass index (BMI) greater than 30.5 (obesity grade II). BMI estimated as mass (kg) / corporal surface (m2).
- Women who are pregnant or intend to become pregnant or breast-feeding
Show all 10Show fewer
- Neoplasia
- Immunosuppressive states
- Participation in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in the study.
- Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Teknon Medical Center, ITRT
Barcelona, Barcelona, 08022
Instituto de Biologia y Genetica Molecular (IBGM), University of Valladolid
Valladolid, Valladolid, 47003
About this study
Official title: Regeneration of Articular Cartilage in Grade II, III and IV Knee Osteoarthritis by Intraarticular Injection of Autologous Bone Marrow Stem Cells Expanded ex Vivo With a GMP Procedure Developed by IBGM-Valladolid (MSV)
In this prospective study we aim to evaluate the feasibility and safety of the implantation of 40 millions MSV in knees with osteoarthritis of grade II-IV (Kellgren and Lawrence). The working hypothesis proposes that MSV antiinflammatory effect will help healing of articular cartilage degeneration to a grade enough to be objectivized by questionnaires and imaging procedures. The study of quantitative changes in structure and composition of cartilage determined by MRI T2-mapping (Cartigram ) will be performed at 6, 12 and 24 months. Pain and disability will be assessed by visual analogue scale (VAS), WOMAC, Lequesne Index and evaluation of the quality of life by Short Form 36 questionnaire (SF-36) completed at 3, 6,12 and 24 months.
Read the detailed description
Knee osteoarthritis is the most common form of arthritis. Treatments involve high costs in terms of social and economic, are palliative and do not contemplate healing by regenerative therapy. It has been shown recently, that mesenchymal stem cells (MSC) can be expanded "in vitro" and may regenerate several damaged or injured tissues. In addition its has demonstrated that MSC are able to modulate immune responses and to control inflammation through its action on T lymphocytes. Preliminary studies in animal models, including one carried out in an equine by our research group, confirms feasibility, safety and efficacy evidence proposed treatment protocol. Our research group has also experience in preparing clinical-grade MSC from bone marrow for other clinical trials and has all the necessary facilities and permissions to comply with GMPs imposed by recent EU legislation. Finally, our clinical team has a wide experience in regenerative therapies in several previous clinical trials for bone and cartilage.
We present here an alternative proposal, aiming to anti-inflammation and regeneration by injection of single dose of mesenchymal stem cells expanded from autologous bone marrow by the GMP-complying IBGM-Valladolid procedure (MSV). Treatment involves two non-invasive surgical procedures with low morbidity: obtaining bone marrow under local anesthesia and sedation, and 4 weeks later, articular injection of the cell product (20 millions MSVs). The injection of cells does not even require anesthesia and obtaining bone marrow requires an outpatient admission two hours following safety criteria.
Patients will be evaluated clinically, including pain score (VSA), pain and disability indexes (WOMAC and Lequesne) and life quality (SF-36), and by radiologic and MRI procedures no contrast and allowing quantification of morphological and structural changes of the cartilage region studied (MRI T2-mapping).
The design of the study is an open-label prospective, multicenter study. It will recruit 12 patients with osteoarthritis of II-IV Kellgren and Lawrence grades, Patients will be evaluated clinically by previous studies imaging (X-rays and MRI). If they are eligible for the study we shall provide them information about the clinical trial with the "Patient Information Sheet, quoting them for the Inclusion Visit. In the "Inclusion Visit" if the patient decides to participate in the test should sign the Informed Consent Document and a schedule for MRI and X-rays will be scheduled. The results of this exploration will be considered the standard to which compare any given change in the controls at 6 and 12 months. On this visit, routine preoperative examinations are performed (EKG, chest X-ray AP, basic analytic coagulation tests and identification of HIV, Lues and hepatitis B and C and the valuation by the Internal Medicine Service).
During the visit V0 we shall verify that all inclusion criteria persist and not exclusion criteria have appeared, and we shall program V1 (to obtain bone marrow) and provide a preliminary date for MSV injection 4 week later (V2). After application, the patients will have follow-up schedule at 8 days (V3), 3 (V4), 6 (V5), 12 (V6) and eventually 24 months (V7) as detailed below.
V0: Eligibility. Clinical History. Analysis, Imaging test. Programming of the following visits V1 (day 0): Bone marrow aspiration under local anesthesia and sedation V2 (day 23). MSV Implantation. V3 (+8 days from Implantation): Security evaluation. V4 (+3 months from Implantation): Security evaluation. VAS, WOMAC, Lequesne Index, SF-36 questionnaires.
V5 (+6 months from Implantation): Security evaluation. VAS, WOMAC, Lequesne Index, SF-36 questionnaires, RX, RNM.
V6 (+12 months from Implantation): Security evaluation. VAS, WOMAC, Lequesne Index, SF-36 questionnaires, RX, RNM.
V7 (+24 months from Implantation): Security evaluation. VAS, WOMAC, Lequesne Index, SF-36 questionnaires, RX, RNM.
- Being tested
- Autologous bone marrow mesenchymal stem cells (MSV)
- Keywords
- Knee degenerative disease, osteoarthritis, gonarthrosis, stem cell, cellular therapy, regenerative therapy, Mesenchymal stem cells, Bone marrow, musculoskeletal Diseases
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous bone marrow mesenchymal stem cells (MSV)Other
Also called MSV, mesenchymal stem cells by IBGM-Valladolid protocol.
Bone marrow collection from patient, mesenchymal cells isolation and expansion under GMP conditions following the IBGM-Valladolid protocol (MSV). Autologous MSV implantation by articular injection.
| Study group | Role | What they receive |
|---|---|---|
| MSV autologous transplantation | Experimental | Bone marrow collected from patient will be used for mesenchymal stem cells isolation and expansion under GMP conditions at IBGM-Valladolid (MSV). Autologous MSV implanted in knee by articular injection Receives: Other: Autologous bone marrow mesenchymal stem cells (MSV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
Clinical review, questionaires (VAS - Visual Analogue Scale (a psychometric response scale which can be used for subjective measurements of knee pain), WOMAC - Western Ontario and McMaster Universities Osteoarthritis Index (questionnaire to quantify the pain, stiffness and physical function in patients with osteoarthritis of the knee or hip), Lequesne Index (is a composite measure of pain and disability, with specific self-report questionnaires for knee (osteoarthritis)), SF36 life quality - Short Form 36 (is a questionnaire for the detection of changes in quality of life)).
In all cases, the scale was from 0 to 100%. Measurements were performed before cell transplantation (0) and 3, 6, 12 and 24 months afterwards depending on the questionnaire. For VAS, WOMAC and Lequesne, lower values represent a better outcome. For SF-36, higher values represent a better outcome.
VAS-DA, VAS for pain associated to daily activities. VAS-SP, VAS for pain associated to sports activities.
Measured: 0, 3, 6, 12 and 24 months
Secondary outcomes (1)
Indication of Efficacy
Clinical exploration, questionaires (VAS, WOMAC, Lequesne Index, SF-36 life quality) at all the periods. To evaluate effectiveness through development of criteria for quantitative MRI (Cartigram) denoting regeneration of articular cartilage at 6, 12 and 24 months after the implantation of MSV.
Magnetic Resonance imaging measurements of T2 relaxation (Cartigram) performed at 0, 6 and 12 months to quantify articular cartilage degeneration. The values (in milliseconds) are T1/2 for decay of the T2 MRI signals. Normal values are below 50 ms; values above 50 ms correspond to inflamed cartilage.
Mean (SD) are expressed as the percent of values (of a total of 88 measurements) that are between 50 and 90 ms. A value =5 is considered normal (can be attained by chance). Values above 5 are considered pathological. The worst possible is 100.
Measured: 0, 6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2010 (estimated)
- Study startMay 2010
- Primary completionAug 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Red de Terapia Celular
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fundacion Teknon, Centro Medico Teknon, Barcelona, University of Valladolid, Centro en Red de Medicina Regenerativa de Castilla y Leon, Institut de Terapia Regenerativa Tissular, EGARSAT Suma Intermutual, Barcelona, Spain, Cetir Sant Jordi, S.a..
- Responsible party
- Sponsor
- Investigators
- Luis Orozco, MD, PhD, Principal investigator, Fundacion TeknonAna Sanchez, MD, PhD, Study director, IBGM, University of ValladolidRobert Soler, MD, Study director, Institut de Teràpia Regenerativa Tissular, Centro Médico TeknonJavier Garcia-Sancho, MD, PhD, Study director, IBGM, University of Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01183728
- Sponsor's protocol ID
- TerCel001
- Other IDs
- Eudra-CT 2009-017405-11, Protocol Code
- Acronym
- KDD&MSV
- Status last verified
- Jan 2015
- First submitted
- 13 Aug 2010
- Last updated
- 15 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Orozco L, Munar A, Soler R, Alberca M, Soler F, Huguet M, Sentis J, Sanchez A, Garcia-Sancho J. Treatment of knee osteoarthritis with autologous mesenchymal stem cells: a pilot study. Transplantation. 2013 Jun 27;95(12):1535-41. doi: 10.1097/TP.0b013e318291a2da.
PubMed 23680930Orozco L, Munar A, Soler R, Alberca M, Soler F, Huguet M, Sentis J, Sanchez A, Garcia-Sancho J. Treatment of knee osteoarthritis with autologous mesenchymal stem cells: two-year follow-up results. Transplantation. 2014 Jun 15;97(11):e66-8. doi: 10.1097/TP.0000000000000167. No abstract available.
PubMed 24887752
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regeneration of Articular Cartilage in Grade II, III and IV Knee Osteoarthritis by Intraarticular Injection of Autologous Bone Marrow Stem Cells Expanded ex Vivo With a GMP Procedure Developed by IBGM-Valladolid (MSV)
- ClinicalTrials.gov ID
- NCT01183728
- Acronym / sponsor ID
- KDD&MSV / TerCel001
- Keywords
- Knee degenerative disease, osteoarthritis, gonarthrosis, stem cell, cellular therapy, regenerative therapy, Mesenchymal stem cells, Bone marrow
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Red de Terapia CelularIndustry (pharma, biotech, devices)
- Collaborators
- Fundacion Teknon, Centro Medico Teknon, Barcelona, University of Valladolid, Centro en Red de Medicina Regenerativa de Castilla y Leon, Institut de Terapia Regenerativa Tissular, EGARSAT Suma Intermutual, Barcelona, Spain, Cetir Sant Jordi, S.a..
- Study start
- May 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 18 Aug 2010 (estimated)
- Results
- Posted 15 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this prospective study we aim to evaluate the feasibility and safety of the implantation of 40 millions MSV in knees with osteoarthritis of grade II-IV (Kellgren and Lawrence). The working hypothesis proposes that MSV antiinflammatory effect will help healing of articular cartilage degeneration to a grade enough to be objectivized by questionnaires and imaging procedures. The study of quantitative changes in structure and composition of cartilage determined by MRI T2-mapping (Cartigram ) will be performed at 6, 12 and 24 months. Pain and disability will be assessed by visual analogue scale (VAS), WOMAC, Lequesne Index and evaluation of the quality of life by Short Form 36 questionnaire (SF-36) completed at 3, 6,12 and 24 months.
Detailed description
Knee osteoarthritis is the most common form of arthritis. Treatments involve high costs in terms of social and economic, are palliative and do not contemplate healing by regenerative therapy. It has been shown recently, that mesenchymal stem cells (MSC) can be expanded "in vitro" and may regenerate several damaged or injured tissues. In addition its has demonstrated that MSC are able to modulate immune responses and to control inflammation through its action on T lymphocytes. Preliminary studies in animal models, including one carried out in an equine by our research group, confirms feasibility, safety and efficacy evidence proposed treatment protocol. Our research group has also experience in preparing clinical-grade MSC from bone marrow for other clinical trials and has all the necessary facilities and permissions to comply with GMPs imposed by recent EU legislation. Finally, our clinical team has a wide experience in regenerative therapies in several previous clinical trials for bone and cartilage.
We present here an alternative proposal, aiming to anti-inflammation and regeneration by injection of single dose of mesenchymal stem cells expanded from autologous bone marrow by the GMP-complying IBGM-Valladolid procedure (MSV). Treatment involves two non-invasive surgical procedures with low morbidity: obtaining bone marrow under local anesthesia and sedation, and 4 weeks later, articular injection of the cell product (20 millions MSVs). The injection of cells does not even require anesthesia and obtaining bone marrow requires an outpatient admission two hours following safety criteria.
Patients will be evaluated clinically, including pain score (VSA), pain and disability indexes (WOMAC and Lequesne) and life quality (SF-36), and by radiologic and MRI procedures no contrast and allowing quantification of morphological and structural changes of the cartilage region studied (MRI T2-mapping).
The design of the study is an open-label prospective, multicenter study. It will recruit 12 patients with osteoarthritis of II-IV Kellgren and Lawrence grades, Patients will be evaluated clinically by previous studies imaging (X-rays and MRI). If they are eligible for the study we shall provide them information about the clinical trial with the "Patient Information Sheet, quoting them for the Inclusion Visit. In the "Inclusion Visit" if the patient decides to participate in the test should sign the Informed Consent Document and a schedule for MRI and X-rays will be scheduled. The results of this exploration will be considered the standard to which compare any given change in the controls at 6 and 12 months. On this visit, routine preoperative examinations are performed (EKG, chest X-ray AP, basic analytic coagulation tests and identification of HIV, Lues and hepatitis B and C and the valuation by the Internal Medicine Service).
During the visit V0 we shall verify that all inclusion criteria persist and not exclusion criteria have appeared, and we shall program V1 (to obtain bone marrow) and provide a preliminary date for MSV injection 4 week later (V2). After application, the patients will have follow-up schedule at 8 days (V3), 3 (V4), 6 (V5), 12 (V6) and eventually 24 months (V7) as detailed below.
V0: Eligibility. Clinical History. Analysis, Imaging test. Programming of the following visits V1 (day 0): Bone marrow aspiration under local anesthesia and sedation V2 (day 23). MSV Implantation. V3 (+8 days from Implantation): Security evaluation. V4 (+3 months from Implantation): Security evaluation. VAS, WOMAC, Lequesne Index, SF-36 questionnaires.
V5 (+6 months from Implantation): Security evaluation. VAS, WOMAC, Lequesne Index, SF-36 questionnaires, RX, RNM.
V6 (+12 months from Implantation): Security evaluation. VAS, WOMAC, Lequesne Index, SF-36 questionnaires, RX, RNM.
V7 (+24 months from Implantation): Security evaluation. VAS, WOMAC, Lequesne Index, SF-36 questionnaires, RX, RNM.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MSV autologous transplantation | Experimental | Other: Autologous bone marrow mesenchymal stem cells (MSV)Bone marrow collected from patient will be used for mesenchymal stem cells isolation and expansion under GMP conditions at IBGM-Valladolid (MSV). Autologous MSV implanted in knee by articular injection |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Knee osteoarthritis grade II, III and IV of Kellgren and Lawrence assessed by two observers.
- Chronic knee pain with mechanical characteristics.
- No local or systemic septic process.
- Haematological and biochemical analysis without significant alterations that contraindicate treatment.
- Informed written consent of the patient.
Key exclusion criteria (10 listed)
- Age over 75 or under 18 years or legally dependent
- Any sign of infection
- Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg, Anti-HCV-Ab), Hepatitis C (Anti-HCV-Ab) and syphilis.
- Congenital or acquired malformation resulting in significant deformity of the knee and leading to problems in application or evaluation of results.
- Overweight expressed as body mass index (BMI) greater than 30.5 (obesity grade II). BMI estimated as mass (kg) / corporal surface (m2).
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 bone marrow mesenchymal stem cells (MSV)Also: MSV, mesenchymal stem cells by IBGM-Valladolid protocol.Bone marrow collection from patient, mesenchymal cells isolation and expansion under GMP conditions following the IBGM-Valladolid protocol (MSV). Autologous MSV implantation by articular injection. | Other | MSV autologous transplantation |
Primary outcome
Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
Time frame: 0, 3, 6, 12 and 24 months
Clinical review, questionaires (VAS - Visual Analogue Scale (a psychometric response scale which can be used for subjective measurements of knee pain), WOMAC - Western Ontario and McMaster Universities Osteoarthritis Index (questionnaire to quantify the pain, stiffness and physical function in patients with osteoarthritis of the knee or hip), Lequesne Index (is a composite measure of pain and disability, with specific self-report questionnaires for knee (osteoarthritis)), SF36 life quality - Short Form 36 (is a questionnaire for the detection of changes in quality of life)). In all cases, the scale was from 0 to 100%. Measurements were performed before cell transplantation (0) and 3, 6, 12 and 24 months afterwards depending on the questionnaire. For VAS, WOMAC and Lequesne, lower values represent a better outcome. For SF-36, higher values represent a better outcome. VAS-DA, VAS for pain associated to daily activities. VAS-SP, VAS for pain associated to sports activities.
1 secondary outcome
Indication of Efficacy
Time frame: 0, 6, 12, 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23680930Orozco L, Munar A, Soler R, Alberca M, Soler F, Huguet M, Sentis J, Sanchez A, Garcia-Sancho J. Treatment of knee osteoarthritis with autologous mesenchymal stem cells: a pilot study. Transplantation. 2013 Jun 27;95(12):1535-41. doi: 10.1097/TP.0b013e318291a2da.
- Results publication: PubMed 24887752Orozco L, Munar A, Soler R, Alberca M, Soler F, Huguet M, Sentis J, Sanchez A, Garcia-Sancho J. Treatment of knee osteoarthritis with autologous mesenchymal stem cells: two-year follow-up results. Transplantation. 2014 Jun 15;97(11):e66-8. doi: 10.1097/TP.0000000000000167. No abstract available.
- Cell application, ITRT-Centro Médico TeknonLink provided by the sponsor.
- Cell production, Instituto de Biologia y Genetica Molecular (IBGM) University of ValladolidLink provided by the sponsor.
- osteoarthritis, kneeLink provided by the sponsor.
- MSV Cell ProductionLink provided by the sponsor.
Related trials for Osteoarthritis, Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
Luis Orozco, MD, PhD principal investigator
Fundacion Teknon
Ana Sanchez, MD, PhD study director
IBGM, University of Valladolid
Robert Soler, MD study director
Institut de Teràpia Regenerativa Tissular, Centro Médico Teknon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous bone marrow mesenchymal stem cells (MSV) in people with Osteoarthritis, Knee and Knee Degenerative Disease, run by Red de Terapia Celular at 2 sites in Spain.
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 10 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 15 Jan 2015. 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 Spain. 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 combined 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.
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?
Yes. Results are posted in the registry (first posted 15 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee. (time frame: 0, 3, 6, 12 and 24 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 NCT01183728, which also lists 2 linked publications.
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 15 Jan 2015.