Osteochondral Fracture of TalusPhase 3OLTNCT03905824
The Effectiveness of Adding Allogenic Stem Cells After Traditional Treatment of Osteochondral Lesions of the Talus
A Phase 3 study testing Allogenic stromal mesenchymal cells derived from the umbilical cord and Debridement and microfracture in people with Osteochondral Fracture of Talus, run by University of Chile at 1 site in Chile.
Trial summary
Randomized, multicentric, prospective, double-blind study: effectiveness of adding allogenic stem cells to a platelet-poor plasma scaffold after arthroscopic debridement and microfractures in patients with osteochondral lesions of the talus Osteochondral lesions of the talus (LOC), affects the ankle cartilage, which… Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Osteochondral Fracture of Talus
- What is being tested?
- Allogenic stromal mesenchymal cells derived from the umbilical cord and Debridement and microfracture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChile
- Study dates
- 15 Jan 2019to 31 Dec 2024
- Phase
- Phase 3
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with a symptomatic osteochondral lesion of the Talus.
- Magnetic resonance of the ankle showing osteochondral injury of a single talus, with perilesional oedema
Who cannot join
- Recurrent osteochondral lesions of the talus
- Multiple osteochondral lesions
- Severe ankle instability, requiring open repair
- History of a previous foot or ankle surgery of the ipsilateral foot
- Rheumatoid arthritis
- Inability to return to the surgery site to practice long-term follow-up evaluations or lack of readiness to complete the indicated evaluation forms.
- Patients with a qualitative or quantitative commitment that prevents consent or assent their participation in the study.
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Universidad de Chile Clinical Hospital
Santiago, Independencia, 8380456
Aaron Cortes, PhD, +56942255914, aacortes@hcuch.cl
Manuel Pellegrini, MD
About this study
Official title: Randomized, Multicentric, Prospective, Double-blind Study: Effectiveness of Adding Allogenic Stem Cells to a Platelet-poor Plasma Scaffold After Arthroscopic Debridement and Microfractures in Patients With Osteochondral Lesions of the Talus
Randomized, multicentric, prospective, double-blind study: effectiveness of adding allogenic stem cells to a platelet-poor plasma scaffold after arthroscopic debridement and microfractures in patients with osteochondral lesions of the talus Osteochondral lesions of the talus (LOC), affects the ankle cartilage, which it seems to have less repair capacity than that of other joints such as the knee of the hip. The LOC can be an important source of pain and affects comparatively younger, working age and athletically active patients.
Although there are several therapeutic strategies, debridement and microfractures performed arthroscopically are the most frequent procedures. After this surgery, it is expected that fibrocartilage will form that covers the osteochondral lesion. Though good results have been reported, this fibrocartilage presents histological characteristics of lower quality to those of the native articular cartilage.
Read more
Based on previous studies in different joints, it is hypothesized that the augmentation treatment of osteochondral lesions of the talus with mesenchymal allogeneic stromal cells derived from the umbilical cord produces better clinical and imaging results than standard treatment with debridement and microfractures only.
Therefore, the present study seeks to compare the effectiveness of traditional debridement and microfracture treatment versus adding a platelet-poor plasma (PPP) scaffold embedded in allogeneic mesenchymal stromal cells derived from the umbilical cord in patients with osteochondral lesions of the talus.
Read the detailed description
As with other major joints of the lower limb that carry weight (hip, knee), the osteochondral lesion (LOC) of the talus, can be a major source of pain and disability for the affected patient. The LOC of the talus can appear after one (or repeated) traumatic injury, compromises the bone and adjacent cartilage, being able to cause blisters in the cartilage layers, lesions similar to a cyst within the bone under the cartilage, or fracture of the cartilage and the bony layers.
The ankle joint supports multiple loads of the corporal weight in the daily activities, the reason why the properties of the cartilage in the ankle are different from those that appear in the hip and the knee. In the absence of an injury, the cartilage of the ankle has better resistance and tension properties to face the increase of forces than the hip or knee throughout life.
However, once an injury appears, the cartilage of the ankle appears to have less repair capacity compared to the hip or knee. Since the most common cause of LOC of the talus is post-traumatic, the average age of these patients is comparatively lower than that of patients affected by injuries to other joints.
Osteochondral injuries have an incidence of 27 per 10,0000 inhabitants in the USA. They are injuries that usually affect the working population and active sportsperson, producing pain, functional limitation and that probably contribute towards the evolution of an accelerated joint degeneration. Currently, there are multiple treatment modalities used by ankle and foot surgeons. These include debridement and microfractures of the subchondral plaque, utilization of totipotential cells, osteochondral autograft/allograft, tibiotalar arthrodesis, and partial/total ankle arthroplasty. However, no treatment offers a clear superiority over the others.
Debridement and microfractures performed arthroscopically is the most frequently used procedure and involves; the removal of degenerated cartilage and subchondral bone; obtaining firm lesional edges that prevent the spread of the lesion; and finally the stimulation of the bone marrow talar by performing microfractures of the subchondral plate. This with the hope that fibrocartilage will form that covers the osteochondral lesion. Although this fibrocartilage has histological characteristics different from those of native articular cartilage, good results have been reported in 82% of the cases when combining good quality studies in this regard.
The standard technique is not able to generate a replacement articular cartilage strong enough to support the joint loads to which the ankle is exposed. Therefore, clinical trials seek to increase the traditional treatment of debridement and microfractures with the intra-articular use of totipotent cells at the end of the procedure. Although the results of these series are promising and comparable at least to those of traditional treatment, the absence of comparative studies between them complicates the choice of treatment for both the patient and the surgeon. For this reason, the investigators have designed a prospective, comparative, double-blind study that will allow elucidating which of these interventions is the best alternative for our patients.
General Objective:
To compare the effectiveness of traditional debridement and microfracture treatment versus adding a platelet-poor plasma (PPP) scaffold embedded in allogenic stromal mesenchymal cells derived from the umbilical cord in patients with osteochondral lesions of the talus.
Specific Objectives:
- To compare functional and radiological results before versus post-surgery within each group studied (control and experimental)
- To compare functional results after surgery of the groups in traditional treatment versus traditional treatment plus mesenchymal stromal cells (MSC).
- To compare the quality of repair of the tissues of the groups in traditional treatment versus traditional treatment plus mesenchymal stromal cells (MSC).
Work hypothesis:
The augmentation treatment of the osteochondral lesions of the talus with mesenchymal cells produces better clinical and imaging results than standard treatment with only debridement and microfractures.
- Conditions
- Osteochondral Fracture of Talus
- Being tested
- Allogenic stromal mesenchymal cells derived from the umbilical cord, Debridement and microfracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogenic stromal mesenchymal cells derived from the umbilical cordBiological
Platelet-poor plasma (PPP) scaffold embedded in allogenic stromal mesenchymal cells derived from the umbilical cord added to the traditional treatment for osteochondral lesions of the talus
Debridement and microfractureProcedure or surgery
Debridement and microfracture in LOC is the traditional treatment for osteochondral lesions of the talus
| Study group | Role | What they receive |
|---|---|---|
| Debridement and microfracture in LOC + Cells | Experimental | Traditional debridement and microfracture treatment adding a platelet-poor plasma (PPP) scaffold embedded in allogenic stromal mesenchymal cells derived from the umbilical cord in patients with osteochondral lesions of the talus. Receives: Biological: Allogenic stromal mesenchymal cells derived from the umbilical cord; Procedure: Debridement and microfracture |
| Debridement and microfracture in LOC | Active comparator | Traditional debridement and microfracture treatment in patients with osteochondral lesions of the talus. Receives: Procedure: Debridement and microfracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on tissue reparation quality
Magnetic resonance observation of cartilage repair tissue (MOCART). The MOCART classification is one of the most frequently used MR score for postoperative cartilage repair tissue evaluation. The MOCART score is a 9-part and 29-item scoring system, also resulting in a final cartilage repair tissue score between 0 and 100 points; 0 points represent the worst imaginable score, 100 points represent the best imaginable score.
Measured: Baseline and 1 year follow up
Change over time of general health status
The MOS SF-36, It is a generic scale to evaluate health/disease status. It comprises 36 items divided into two components: Physical Health (PH) and Mental Health (MH). PH includes four subscales: Physical Function (PF), Role Physical (RP), Bodily Pain (BP), and General Health (GH). MH includes four subscales: Vitality (V), Social functioning (SF), Role Emotional (RE), and General Health (GH).
Each component (PH and MH) and each of the eight subscale scores are transformed into a 0-to-100 scale. Higher scores represent better health status
Measured: Baseline, 1 year and 2 years follow up
Change over time of functional limitations of foot and ankle.
The Foot and Ankle Outcome Score (FAOS) evaluates functional limitations related to foot and ankle issues. Consist in 42 items that cover 5 dimensions: Symptoms (S: 7 items), Pain (P: 9 items), Activities of Daily Living (ADL: 17 items), Sport and Recreation Activities (SRA: 5 items), and foot and ankle related Quality of Life (QoL: 4 items). Raw scores of each sub-scales results of the sum of each item score.
These raw scores are standardised into a 0 to 100 scale; higher scores mean higher dysfunction due to foot/ankle condition.
Measured: Baseline, 1 year and 2 years follow up
Change over time of functionality of musculoskeletal ankle and foot pathology
The Foot and Ankle Ability Measure (FAAM) scale aims to evaluate overtime changes in the functionality of the same patient in musculoskeletal ankle and foot pathology. It is a survey that consists of 21 items about activities of daily living, and 8 items about sports skills.
Raw scores of each sub-scales are standardised into a 0 to 100 scale; higher scores mean higher dysfunction due to foot/ankle condition.
Measured: Baseline, 1 year and 2 years follow up
Change on declared pain
Visual Analog Scale for Pain (VAS-Pain): a pain rating scale based on self-reported measures of symptoms. A 10cm line numbered from 0 to 10 represents a continuum between "no pain" (zero) and "worst pain" (ten).
It can also be interpreted as a 0-to-100 points score.
Measured: Baseline, 1 year and 2 years follow up
Secondary outcomes (3)
Surgical time
Duration (in minutes) of the surgery
Measured: During surgery
Complication rate
Including the number of participants with:
- post-surgery infections
- temporal or permanent damage of nerve as a result of pressure or hematoma
- with venose thrombosis, pulmonary embolism or heart stroke
Measured: Two years follow up from baseline (surgery)
Cost-effective comparative analysis
Comparison of the overall costs and results of both groups
Measured: Two years follow up from baseline (surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start15 Jan 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteochondral Fracture of TalusStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel J Pellegrini, University of Chile
- Investigators
- Manuel Pellegrini, MD, Principal investigator, Universidad de Chile Clinical Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905824
- Sponsor's protocol ID
- OLT Protocol
- Acronym
- OLT
- Status last verified
- Apr 2019
- First submitted
- 29 Mar 2019
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multicentric, Prospective, Double-blind Study: Effectiveness of Adding Allogenic Stem Cells to a Platelet-poor Plasma Scaffold After Arthroscopic Debridement and Microfractures in Patients With Osteochondral Lesions of the Talus
- ClinicalTrials.gov ID
- NCT03905824
- Acronym / sponsor ID
- OLT / OLT Protocol
- Conditions
- Osteochondral Fracture of Talus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Apr 2019 (actual)
- 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.
Randomized, multicentric, prospective, double-blind study: effectiveness of adding allogenic stem cells to a platelet-poor plasma scaffold after arthroscopic debridement and microfractures in patients with osteochondral lesions of the talus Osteochondral lesions of the talus (LOC), affects the ankle cartilage, which it seems to have less repair capacity than that of other joints such as the knee of the hip. The LOC can be an important source of pain and affects comparatively younger, working age and athletically active patients.
Although there are several therapeutic strategies, debridement and microfractures performed arthroscopically are the most frequent procedures. After this surgery, it is expected that fibrocartilage will form that covers the osteochondral lesion. Though good results have been reported, this fibrocartilage presents histological characteristics of lower quality to those of the native articular cartilage.
Based on previous studies in different joints, it is hypothesized that the augmentation treatment of osteochondral lesions of the talus with mesenchymal allogeneic stromal cells derived from the umbilical cord produces better clinical and imaging results than standard treatment with debridement and microfractures only.
Therefore, the present study seeks to compare the effectiveness of traditional debridement and microfracture treatment versus adding a platelet-poor plasma (PPP) scaffold embedded in allogeneic mesenchymal stromal cells derived from the umbilical cord in patients with osteochondral lesions of the talus.
Detailed description
As with other major joints of the lower limb that carry weight (hip, knee), the osteochondral lesion (LOC) of the talus, can be a major source of pain and disability for the affected patient. The LOC of the talus can appear after one (or repeated) traumatic injury, compromises the bone and adjacent cartilage, being able to cause blisters in the cartilage layers, lesions similar to a cyst within the bone under the cartilage, or fracture of the cartilage and the bony layers.
The ankle joint supports multiple loads of the corporal weight in the daily activities, the reason why the properties of the cartilage in the ankle are different from those that appear in the hip and the knee. In the absence of an injury, the cartilage of the ankle has better resistance and tension properties to face the increase of forces than the hip or knee throughout life.
However, once an injury appears, the cartilage of the ankle appears to have less repair capacity compared to the hip or knee. Since the most common cause of LOC of the talus is post-traumatic, the average age of these patients is comparatively lower than that of patients affected by injuries to other joints.
Osteochondral injuries have an incidence of 27 per 10,0000 inhabitants in the USA. They are injuries that usually affect the working population and active sportsperson, producing pain, functional limitation and that probably contribute towards the evolution of an accelerated joint degeneration. Currently, there are multiple treatment modalities used by ankle and foot surgeons. These include debridement and microfractures of the subchondral plaque, utilization of totipotential cells, osteochondral autograft/allograft, tibiotalar arthrodesis, and partial/total ankle arthroplasty. However, no treatment offers a clear superiority over the others.
Debridement and microfractures performed arthroscopically is the most frequently used procedure and involves; the removal of degenerated cartilage and subchondral bone; obtaining firm lesional edges that prevent the spread of the lesion; and finally the stimulation of the bone marrow talar by performing microfractures of the subchondral plate. This with the hope that fibrocartilage will form that covers the osteochondral lesion. Although this fibrocartilage has histological characteristics different from those of native articular cartilage, good results have been reported in 82% of the cases when combining good quality studies in this regard.
The standard technique is not able to generate a replacement articular cartilage strong enough to support the joint loads to which the ankle is exposed. Therefore, clinical trials seek to increase the traditional treatment of debridement and microfractures with the intra-articular use of totipotent cells at the end of the procedure. Although the results of these series are promising and comparable at least to those of traditional treatment, the absence of comparative studies between them complicates the choice of treatment for both the patient and the surgeon. For this reason, the investigators have designed a prospective, comparative, double-blind study that will allow elucidating which of these interventions is the best alternative for our patients.
General Objective:
To compare the effectiveness of traditional debridement and microfracture treatment versus adding a platelet-poor plasma (PPP) scaffold embedded in allogenic stromal mesenchymal cells derived from the umbilical cord in patients with osteochondral lesions of the talus.
Specific Objectives:
- To compare functional and radiological results before versus post-surgery within each group studied (control and experimental)
- To compare functional results after surgery of the groups in traditional treatment versus traditional treatment plus mesenchymal stromal cells (MSC).
- To compare the quality of repair of the tissues of the groups in traditional treatment versus traditional treatment plus mesenchymal stromal cells (MSC).
Work hypothesis:
The augmentation treatment of the osteochondral lesions of the talus with mesenchymal cells produces better clinical and imaging results than standard treatment with only debridement and microfractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Debridement and microfracture in LOC + Cells | Experimental | Biological: Allogenic stromal mesenchymal cells derived from the umbilical cord, Procedure: Debridement and microfractureTraditional debridement and microfracture treatment adding a platelet-poor plasma (PPP) scaffold embedded in allogenic stromal mesenchymal cells derived from the umbilical cord in patients with osteochondral lesions of the talus. |
| Debridement and microfracture in LOC | Active comparator | Procedure: Debridement and microfractureTraditional debridement and microfracture treatment in patients with osteochondral lesions of the talus. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with a symptomatic osteochondral lesion of the Talus.
- Magnetic resonance of the ankle showing osteochondral injury of a single talus, with perilesional oedema
Key exclusion criteria (7 listed)
- Recurrent osteochondral lesions of the talus
- Multiple osteochondral lesions
- Severe ankle instability, requiring open repair
- History of a previous foot or ankle surgery of the ipsilateral foot
- Rheumatoid arthritis
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 |
|---|---|---|
| Allogenic stromal mesenchymal cells derived from the umbilical cordPlatelet-poor plasma (PPP) scaffold embedded in allogenic stromal mesenchymal cells derived from the umbilical cord added to the traditional treatment for osteochondral lesions of the talus | Biological | Debridement and microfracture in LOC + Cells |
| Debridement and microfractureDebridement and microfracture in LOC is the traditional treatment for osteochondral lesions of the talus | Procedure or surgery | Debridement and microfracture in LOC, Debridement and microfracture in LOC + Cells |
Primary outcome
Change on tissue reparation quality
Time frame: Baseline and 1 year follow up
Magnetic resonance observation of cartilage repair tissue (MOCART). The MOCART classification is one of the most frequently used MR score for postoperative cartilage repair tissue evaluation. The MOCART score is a 9-part and 29-item scoring system, also resulting in a final cartilage repair tissue score between 0 and 100 points; 0 points represent the worst imaginable score, 100 points represent the best imaginable score.
Change over time of general health status
Time frame: Baseline, 1 year and 2 years follow up
The MOS SF-36, It is a generic scale to evaluate health/disease status. It comprises 36 items divided into two components: Physical Health (PH) and Mental Health (MH). PH includes four subscales: Physical Function (PF), Role Physical (RP), Bodily Pain (BP), and General Health (GH). MH includes four subscales: Vitality (V), Social functioning (SF), Role Emotional (RE), and General Health (GH). Each component (PH and MH) and each of the eight subscale scores are transformed into a 0-to-100 scale. Higher scores represent better health status
Change over time of functional limitations of foot and ankle.
Time frame: Baseline, 1 year and 2 years follow up
The Foot and Ankle Outcome Score (FAOS) evaluates functional limitations related to foot and ankle issues. Consist in 42 items that cover 5 dimensions: Symptoms (S: 7 items), Pain (P: 9 items), Activities of Daily Living (ADL: 17 items), Sport and Recreation Activities (SRA: 5 items), and foot and ankle related Quality of Life (QoL: 4 items). Raw scores of each sub-scales results of the sum of each item score. These raw scores are standardised into a 0 to 100 scale; higher scores mean higher dysfunction due to foot/ankle condition.
Change over time of functionality of musculoskeletal ankle and foot pathology
Time frame: Baseline, 1 year and 2 years follow up
The Foot and Ankle Ability Measure (FAAM) scale aims to evaluate overtime changes in the functionality of the same patient in musculoskeletal ankle and foot pathology. It is a survey that consists of 21 items about activities of daily living, and 8 items about sports skills. Raw scores of each sub-scales are standardised into a 0 to 100 scale; higher scores mean higher dysfunction due to foot/ankle condition.
Change on declared pain
Time frame: Baseline, 1 year and 2 years follow up
Visual Analog Scale for Pain (VAS-Pain): a pain rating scale based on self-reported measures of symptoms. A 10cm line numbered from 0 to 10 represents a continuum between "no pain" (zero) and "worst pain" (ten). It can also be interpreted as a 0-to-100 points score.
3 secondary outcomes
Surgical time
Time frame: During surgery
Complication rate
Time frame: Two years follow up from baseline (surgery)
Cost-effective comparative analysis
Time frame: Two years follow up from baseline (surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Manuel Pellegrini, MD principal investigator
Universidad de Chile Clinical Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Allogenic stromal mesenchymal cells derived from the umbilical cord and Debridement and microfracture in people with Osteochondral Fracture of Talus, run by University of Chile at 1 site in Chile.
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 2 inclusion and 7 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 9 Apr 2019. 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 Chile. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Manuel Pellegrini, DM (+56997795613, mpellegrini@hcuch.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on tissue reparation quality (time frame: Baseline and 1 year follow up). The study lists 5 primary outcomes in all. 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 9 Apr 2019.