Knee OsteoarthritisPhase 1/2CMM-PRGF/ARTNCT02365142
Treatment of Osteoarthritis by Intra-articular Injection of Bone Marrow Mesenchymal Stem Cells With Platelet Rich Plasma
A Phase 1/2 study testing 100 million Bone marrow mesenchimal stem cells and Platelet Rich plasma (PRGF) in people with Knee Osteoarthritis, run by Clinica Universidad de Navarra, Universidad de Navarra at 2 sites in Spain.
Trial summary
Purpose: To determine the safety, feasibility and effectiveness (clinical and radiological) of intra-articular administration of autologous mesenchymal stem cells (MSCs) with platelet richa plasma (PRGF) in patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- 100 million Bone marrow mesenchimal stem cells and Platelet Rich plasma (PRGF)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesSpain
- Study dates
- Jun 2014to Jun 2018
- Phase
- Phase 1/2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females between 40 and 80 year old
- Bad results with previous hyaluronic acid injection
- Diagnosis of knee OA according to the criteria of osteoarthritis of the ACR (American College of Rheumatology)
- Joint pain equal or greater than 2.5 points on the visual analogue scale (VAS)
- Radiological Classification: Kellgren-Lawrence scale greater or equal to 2
- Body mass index between 20 and 35 kg/m2
- Ability to follow during the study period
Who cannot join
- Bilateral Osteoarthritis of the Knee requiring treatment in both knees
- Previous diagnosis of polyarticular disease
- Severe mechanical deformation
- Arthroscopy during the previous 6 months
- Intraarticular infiltration of hyaluronic acid in the last 6 months
- Systemic autoimmune rheumatic disease
Show all 12Show fewer
- Poorly controlled diabetes mellitus
- Blood dyscrasias
- Immunosuppressive or anticoagulant treatments
- Treatment with corticosteroids in the 3 months prior to inclusion in the study
- NSAID therapy within 15 days prior to inclusion in the study
- Patients with a history of allergy to penicillin or streptomycin
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Departamento Cirugía Ortopédica y Traumatología. Clinica Universidad de Navarra
Pamplona, Navarre, 31008
Hospital Universitario de Salamanca
Salamanca, Castille and León, 37007
About this study
Official title: Phase I/II. Treatment of Osteoarthritis by Intra-articular Injection of Bone Marrow Mesenchymal Stem Cells With Platelet Rich Plasma(PRGF)
Purpose: To determine the safety, feasibility and effectiveness (clinical and radiological) of intra-articular administration of autologous mesenchymal stem cells (MSCs) with platelet richa plasma (PRGF) in patients with knee osteoarthritis.
Patients and methods
Read more
Clinical trial phase I- II, randomized , multicenter , with two treatment arms and 19 patients for each group. The investigators compare the intraarticular injection of against the administration of two different doses of mesenchymal stem cells with hialuronic acid according to the following scheme:
- Group A: 3 intra-articular injections of platelet rich plasma (PRGF®) separated by 7 days.
- Group B: 3 intra-articular injections of platelet richa plasma (PRGF®) separated by 7 days and one with Mesenchimal stems cells. Intra-articular injection of 100 million autologous mesenchymal progenitor stem cells cultured ex - vivo (cell suspension sterile small volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by an intraarticular injection of platelet richa plasma (PRGF®). The treatment is completed with 2 more injection of platelet richa plasma (PRGF®) separeted by one week.
In addition the investigators assess the response to intra-articular infusion of CMM analyzing the following parameters:
- Clinical assessment of pain and function (Baseline, 1, 3, 6 and 12 months since treatment): VAS , WOMAC , KOOS , EuroQol, SF-16, Lequesne , WOMAC , KOOS.
- Radiographic (baseline and 12 months from treatment): Femorotibial space.
- Radiographic using MRI (baseline and 12 months from treatment): by assessing the number location of the lesions , cartilage thickness , signal intensity , subchondral bone alteration , volume and WORMS and dGEMRIC protocols.
Read the detailed description
Purpose: To determine the safety, feasibility and effectiveness (clinical and radiological) of intra-articular administration of autologous mesenchymal stem cells (MSCs) with platelet richa plasma (PRGF®) in patients with knee osteoarthritis.
Patients and methods
Clinical trial phase I- II, randomized , multicenter , with two treatment arms and 19 patients for each group. The investigators compare the intraarticular injection of against the administration of two different doses of mesenchymal stem cells with hialuronic acid according to the following scheme:
- Group A: 3 intra-articular injections of platelet richa plasma (PRGF®) separated by 7 days.
- Group B: 3 intra-articular injections of platelet richa plasma (PRGF®) separated by 7 days and one with Mesenchimal stem cell. Intra-articular injection of 100 million autologous mesenchymal progenitor stem cells cultured ex - vivo (cell suspension sterile small volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by an intraarticular injection of platelet richa plasma (PRGF®). The treatment is completed with 2 more injection of platelet richa plasma (PRGF®) separeted by one week.
The autologous mesenchymal stem cells are obtained from the iliac crest under local anesthesia and sedation. They are cultured ex vivo The primary endpoint is safety and feasibility. The investigators registered the occurrence of complications and / or adverse effects during the study.
In addition the investigators assess the response to intra-articular infusion of CMM analyzing the following parameters:
- Clinical assessment of pain and function (Baseline, 1, 3, 6 and 12 months since treatment): VAS , WOMAC , KOOS , EuroQol, SF-16, Lequesne , WOMAC , KOOS.
- Radiographic (baseline, 6 and 12 months since treatment): Femorotibial space.
- Radiographic using MRI (baseline, 6 and 12 months since treatment): by assessing the number location of the lesions , cartilage thickness , signal intensity , subchondral bone alteration , volume and WORMS and dGEMRIC protocols.
All patients met the following inclusion and exclusion criteria:
- Conditions
- Knee Osteoarthritis
- Being tested
- 100 million Bone marrow mesenchimal stem cells, Platelet Rich plasma (PRGF)
- Keywords
- Knee Osteoarthritis, Mesenchimal stem cell, Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100 million Bone marrow mesenchimal stem cellsBiological
100 million Bone marrow mesenchimal stem cells with PRGF
Platelet Rich plasma (PRGF)Biological
3 injections of PRGF
| Study group | Role | What they receive |
|---|---|---|
| Platelet Rich Plasma (PRGF) | Active comparator | Platelet Rich plasma (PRGF) 3 intraarticular onjections sepataded by 7 days. Receives: Biological: Platelet Rich plasma (PRGF) |
| BMMSC with Platelet Rich Plasma (PRGF) | Active comparator | Single intraarticular injection of 100 million Bone marrow mesenchimal stem cells and three intraarticular injections of plateler Rich Plasma (PRGF) separatede by 7 days. Receives: Biological: 100 million Bone marrow mesenchimal stem cells; Biological: Platelet Rich plasma (PRGF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Visual analogue scale (VAS) Baseline Visual analogue scale (VAS)
Baseline Visual analogue scale (VAS) prior to the initial dose on day 1
Measured: Day 1
Baseline value of knee injury and osteoarthritis outcome score (Koos).
Prior to the intervention on day 1 value of knee injury and osteoarthritis outcome score (Koos).
Measured: Day 1
Baseline Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC).
Universities Osteoarthritis Index score (WOMAC).
Measured: Day 1
Baseline SF-36 value
Baseline SF-36 value
Measured: Day 1
Baseline euroquol 5D value
Pretreatment euroquol 5D value
Measured: Day 1
Baseline Lequesne index
Prior to the intervention on day 1 Lequesne index
Measured: Day 1
Baseline femorotibial distance
Prior to the intervention femoritibial distance on rosenberg x-ray view
Measured: Day 1
Number of Participants with Serious and Non-Serious Adverse Events Number of Participants with Serious and Non-Serious Adverse Events Number of Participants with Serious and Non-Serious Adverse Events
Participants with Serious and Non-Serious Adverse Events Number of Participants with Serious and Non-Serious Adverse Events During the follow up
Measured: Follow up (up to 12 months)
Visual analogue scale (VAS) at 1 month
Visual analogue scale (VAS) at on month
Measured: 1 month
Visual analogue scale (VAS) at 3 months
Visual analogue scale (VAS) at 3 months
Measured: 3 months
Visual analogue scale (VAS) at 6 months
Visual analogue scale (VAS) at 6 months
Measured: 6 months
Visual analogue scale (VAS) at 12 months
Visual analogue scale (VAS) at 12 months
Measured: 12 months
Value of knee injury and osteoarthritis outcome score (Koos) at 1 month
Value of knee injury and osteoarthritis outcome score (Koos) at 1 month
Measured: 1 month
Value of knee injury and osteoarthritis outcome score (Koos) at 3 month
Value of knee injury and osteoarthritis outcome score (Koos) at 3 month
Measured: 3 Months
Value of knee injury and osteoarthritis outcome score (Koos) at 6 month
Value of knee injury and osteoarthritis outcome score (Koos) at 6 month
Measured: 6 months
Value of knee injury and osteoarthritis outcome score (Koos) at 12 months
Value of knee injury and osteoarthritis outcome score (Koos) at 12 months
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 posted18 Feb 2015 (estimated)
- Study startJun 2014
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
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 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 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- José Lamo-Espinosa, MD, Principal investigator, Clinica Universidad de NavarraFelipe Prosper, MD, PhD, Study director, Clinica Universidad de Navarra, Universidad de NavarraJuan Blanco, MD; PhD, Principal investigator, Complejo Universitario de Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365142
- Sponsor's protocol ID
- CMM-PRGF/ART
- Other IDs
- 2011-006036-23
- Acronym
- CMM-PRGF/ART
- Status last verified
- Oct 2017
- First submitted
- 18 Jul 2014
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lamo-Espinosa JM, Blanco JF, Sanchez M, Moreno V, Granero-Molto F, Sanchez-Guijo F, Crespo-Cullel I, Mora G, San Vicente DD, Pompei-Fernandez O, Aquerreta JD, Nunez-Cordoba JM, Vitoria Sola M, Valenti-Azcarate A, Andreu EJ, Del Consuelo Del Canizo M, Valenti-Nin JR, Prosper F. Phase II multicenter randomized controlled clinical trial on the efficacy of intra-articular injection of autologous bone marrow mesenchymal stem cells with platelet rich plasma for the treatment of knee osteoarthritis. J Transl Med. 2020 Sep 18;18(1):356. doi: 10.1186/s12967-020-02530-6.
PubMed 32948200
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II. Treatment of Osteoarthritis by Intra-articular Injection of Bone Marrow Mesenchymal Stem Cells With Platelet Rich Plasma(PRGF)
- ClinicalTrials.gov ID
- NCT02365142
- Acronym / sponsor ID
- CMM-PRGF/ART / CMM-PRGF/ART
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, Mesenchimal stem cell, Osteoarthritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 18 Feb 2015 (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.
Purpose: To determine the safety, feasibility and effectiveness (clinical and radiological) of intra-articular administration of autologous mesenchymal stem cells (MSCs) with platelet richa plasma (PRGF) in patients with knee osteoarthritis.
Patients and methods
Clinical trial phase I- II, randomized , multicenter , with two treatment arms and 19 patients for each group. The investigators compare the intraarticular injection of against the administration of two different doses of mesenchymal stem cells with hialuronic acid according to the following scheme:
- Group A: 3 intra-articular injections of platelet rich plasma (PRGF®) separated by 7 days.
- Group B: 3 intra-articular injections of platelet richa plasma (PRGF®) separated by 7 days and one with Mesenchimal stems cells. Intra-articular injection of 100 million autologous mesenchymal progenitor stem cells cultured ex - vivo (cell suspension sterile small volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by an intraarticular injection of platelet richa plasma (PRGF®). The treatment is completed with 2 more injection of platelet richa plasma (PRGF®) separeted by one week.
In addition the investigators assess the response to intra-articular infusion of CMM analyzing the following parameters:
- Clinical assessment of pain and function (Baseline, 1, 3, 6 and 12 months since treatment): VAS , WOMAC , KOOS , EuroQol, SF-16, Lequesne , WOMAC , KOOS.
- Radiographic (baseline and 12 months from treatment): Femorotibial space.
- Radiographic using MRI (baseline and 12 months from treatment): by assessing the number location of the lesions , cartilage thickness , signal intensity , subchondral bone alteration , volume and WORMS and dGEMRIC protocols.
Detailed description
Purpose: To determine the safety, feasibility and effectiveness (clinical and radiological) of intra-articular administration of autologous mesenchymal stem cells (MSCs) with platelet richa plasma (PRGF®) in patients with knee osteoarthritis.
Patients and methods
Clinical trial phase I- II, randomized , multicenter , with two treatment arms and 19 patients for each group. The investigators compare the intraarticular injection of against the administration of two different doses of mesenchymal stem cells with hialuronic acid according to the following scheme:
- Group A: 3 intra-articular injections of platelet richa plasma (PRGF®) separated by 7 days.
- Group B: 3 intra-articular injections of platelet richa plasma (PRGF®) separated by 7 days and one with Mesenchimal stem cell. Intra-articular injection of 100 million autologous mesenchymal progenitor stem cells cultured ex - vivo (cell suspension sterile small volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by an intraarticular injection of platelet richa plasma (PRGF®). The treatment is completed with 2 more injection of platelet richa plasma (PRGF®) separeted by one week.
The autologous mesenchymal stem cells are obtained from the iliac crest under local anesthesia and sedation. They are cultured ex vivo The primary endpoint is safety and feasibility. The investigators registered the occurrence of complications and / or adverse effects during the study.
In addition the investigators assess the response to intra-articular infusion of CMM analyzing the following parameters:
- Clinical assessment of pain and function (Baseline, 1, 3, 6 and 12 months since treatment): VAS , WOMAC , KOOS , EuroQol, SF-16, Lequesne , WOMAC , KOOS.
- Radiographic (baseline, 6 and 12 months since treatment): Femorotibial space.
- Radiographic using MRI (baseline, 6 and 12 months since treatment): by assessing the number location of the lesions , cartilage thickness , signal intensity , subchondral bone alteration , volume and WORMS and dGEMRIC protocols.
All patients met the following inclusion and exclusion criteria:
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet Rich Plasma (PRGF) | Active comparator | Biological: Platelet Rich plasma (PRGF)Platelet Rich plasma (PRGF) 3 intraarticular onjections sepataded by 7 days. |
| BMMSC with Platelet Rich Plasma (PRGF) | Active comparator | Biological: 100 million Bone marrow mesenchimal stem cells, Biological: Platelet Rich plasma (PRGF)Single intraarticular injection of 100 million Bone marrow mesenchimal stem cells and three intraarticular injections of plateler Rich Plasma (PRGF) separatede by 7 days. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females between 40 and 80 year old
- Bad results with previous hyaluronic acid injection
- Diagnosis of knee OA according to the criteria of osteoarthritis of the ACR (American College of Rheumatology)
- Joint pain equal or greater than 2.5 points on the visual analogue scale (VAS)
- Radiological Classification: Kellgren-Lawrence scale greater or equal to 2
Key exclusion criteria (12 listed)
- Bilateral Osteoarthritis of the Knee requiring treatment in both knees
- Previous diagnosis of polyarticular disease
- Severe mechanical deformation
- Arthroscopy during the previous 6 months
- Intraarticular infiltration of hyaluronic acid in the last 6 months
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 |
|---|---|---|
| 100 million Bone marrow mesenchimal stem cells100 million Bone marrow mesenchimal stem cells with PRGF | Biological | BMMSC with Platelet Rich Plasma (PRGF) |
| Platelet Rich plasma (PRGF)3 injections of PRGF | Biological | BMMSC with Platelet Rich Plasma (PRGF), Platelet Rich Plasma (PRGF) |
Primary outcome
Baseline Visual analogue scale (VAS) Baseline Visual analogue scale (VAS)
Time frame: Day 1
Baseline Visual analogue scale (VAS) prior to the initial dose on day 1
Baseline value of knee injury and osteoarthritis outcome score (Koos).
Time frame: Day 1
Prior to the intervention on day 1 value of knee injury and osteoarthritis outcome score (Koos).
Baseline Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC).
Time frame: Day 1
Universities Osteoarthritis Index score (WOMAC).
Baseline SF-36 value
Time frame: Day 1
Baseline SF-36 value
Baseline euroquol 5D value
Time frame: Day 1
Pretreatment euroquol 5D value
Baseline Lequesne index
Time frame: Day 1
Prior to the intervention on day 1 Lequesne index
Baseline femorotibial distance
Time frame: Day 1
Prior to the intervention femoritibial distance on rosenberg x-ray view
Number of Participants with Serious and Non-Serious Adverse Events Number of Participants with Serious and Non-Serious Adverse Events Number of Participants with Serious and Non-Serious Adverse Events
Time frame: Follow up (up to 12 months)
Participants with Serious and Non-Serious Adverse Events Number of Participants with Serious and Non-Serious Adverse Events During the follow up
Visual analogue scale (VAS) at 1 month
Time frame: 1 month
Visual analogue scale (VAS) at on month
Visual analogue scale (VAS) at 3 months
Time frame: 3 months
Visual analogue scale (VAS) at 3 months
Visual analogue scale (VAS) at 6 months
Time frame: 6 months
Visual analogue scale (VAS) at 6 months
Visual analogue scale (VAS) at 12 months
Time frame: 12 months
Visual analogue scale (VAS) at 12 months
Value of knee injury and osteoarthritis outcome score (Koos) at 1 month
Time frame: 1 month
Value of knee injury and osteoarthritis outcome score (Koos) at 1 month
Value of knee injury and osteoarthritis outcome score (Koos) at 3 month
Time frame: 3 Months
Value of knee injury and osteoarthritis outcome score (Koos) at 3 month
Value of knee injury and osteoarthritis outcome score (Koos) at 6 month
Time frame: 6 months
Value of knee injury and osteoarthritis outcome score (Koos) at 6 month
Value of knee injury and osteoarthritis outcome score (Koos) at 12 months
Time frame: 12 months
Value of knee injury and osteoarthritis outcome score (Koos) at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2017.
- Derived from this study: PubMed 32948200Lamo-Espinosa JM, Blanco JF, Sanchez M, Moreno V, Granero-Molto F, Sanchez-Guijo F, Crespo-Cullel I, Mora G, San Vicente DD, Pompei-Fernandez O, Aquerreta JD, Nunez-Cordoba JM, Vitoria Sola M, Valenti-Azcarate A, Andreu EJ, Del Consuelo Del Canizo M, Valenti-Nin JR, Prosper F. Phase II multicenter randomized controlled clinical trial on the efficacy of intra-articular injection of autologous bone marrow mesenchymal stem cells with platelet rich plasma for the treatment of knee osteoarthritis. J Transl Med. 2020 Sep 18;18(1):356. doi: 10.1186/s12967-020-02530-6.
- University clinic of navarre trial informationLink 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.
José Lamo-Espinosa, MD principal investigator
Clinica Universidad de Navarra
Felipe Prosper, MD, PhD study director
Clinica Universidad de Navarra, Universidad de Navarra
Juan Blanco, MD; PhD principal investigator
Complejo Universitario de Salamanca
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 100 million Bone marrow mesenchimal stem cells and Platelet Rich plasma (PRGF) in people with Knee Osteoarthritis, run by Clinica Universidad de Navarra, Universidad de Navarra 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 7 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 24 Oct 2017. 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?
Results are not available in the source record.
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?
Baseline Visual analogue scale (VAS) Baseline Visual analogue scale (VAS) (time frame: Day 1). The study lists 16 primary outcomes in all. 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 NCT02365142, 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 Oct 2017.