Critical Limb IschemiaPhase 1/2NCT02145897
To Evaluate the Safety and Efficacy of IM and IV Administration of Autologous ADMSCs for Treatment of CLI
A Phase 1/2 study testing Autologous Stromal Vascular Fraction (SVF) and Autologous Adipose Derieved MSCs in people with Critical Limb Ischemia, run by Kasiak Research Pvt. Ltd. at 1 site in India.
Trial summary
Various preclinical animal studies have shown the potential of stem cells in re-vascularising ischemic limbs and promoting collateral vessel formation. SVF have the potential to facilitate the formation of new blood vessels and skeletal muscle. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- Autologous Stromal Vascular Fraction (SVF) and Autologous Adipose Derieved MSCs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2014to Aug 2015
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Critical limb ischemia (rest pain, un-healing wound/ulcer lasting more than 4 weeks)
- 2. Category 4 \& 5 Rutherford-Becker peripheral vascular disease affecting at least one limb with or without un-healing ulcer/wound of grade I or II on the Wagner scale
- 3. Ankle -brachial index <0.6
- 4. TcpO2 < 45 mm Hg measured at toe
- 5. Life expectancy more than 2 years
- 6. Subjects (male and female), aged 18 to 65 years (both inclusive)
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- 7. Glycosylated hemoglobin (HbA1C) ≤7 %
- 8. INR value of below 2 before liposuction procedure
- 9. Subject should be compliant to the treatment regimen follow like insulin, anti-diabetic drugs for the entire duration of the clinical study
- 10. Subject who are not currently on or have discontinued treatment with immune-suppressants and/or corticosteroids within at least 20 days prior to screening
- 11. Subject willing to give Informed Consent
Who cannot join
- Uncontrolled high blood pressure
- Uncontrolled diabetes with Glycosylated hemoglobin (HbA1C) > 7%
- Severe cardiac insufficiency (Ejection fraction < 35%)
- Frank infected ulcers with purulent discharge resulting in excessive infections, ulcers with exposed bone, fascia, joints, ligaments or tendons (Category 6 Rutherford-Becker peripheral vascular disease)
- Subject diagnosed with cancer undergoing chemotherapy.
- Poor nutritional status as measured by serum albumin <3.0 g/dL.
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- Severe anemia Hb < 7g/dl.
- Subject had a leg revascularization surgery or history of amputation within the last 6 months or be a candidate for revascularization surgery during the course of the study.
- Other unusual or rare forms of diabetes mellitus, or history of diabetic ketoacidosis or osteomyletis.
- Subject unfit to undergo lipoaspiration as determined by the surgeon.
- Subject has a history of bleeding disorder or clotting disorder
- Have any condition, disease, disorder, or clinically significant laboratory abnormality that, in the opinion of the Investigator, would jeopardize the subjects' appropriate participation in this study or obscure the effects of treatment.
- Pregnant or lactating women or women of child-bearing potential not using medically acceptable methods of contraception or women with positive urine pregnancy test (UPT) at screening
- Subjects unwilling or unable to comply with the study procedures
- Have received treatment with any investigational product (IP) or participated in any investigational study within 30 days or 5 half-lives of the IP, whichever is longer, before the Screening Visit.
- -
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Kasiak Research Pvt Ltd
Thane, Maharashtra, 400 610
Pankaj A Thakur, PhD, +91-(022)-411 73461 ext. 461, pankaj.thakur@kasiakresearch.com
Yogesh H Patil, BHMS, +91-(022)-411 73461 ext. 461, yogesh.patil@kasiakresearch.com
About this study
Official title: A Prospective, Multicentric, Phase I/II, Open Label, Randomized, Interventional Study to Evaluate the Safety and Efficacy of Intramuscular and Intravenous Administration of Autologous ADMSCS for Treatment of Critical Limb Ischemia (CLI).
Various preclinical animal studies have shown the potential of stem cells in re-vascularising ischemic limbs and promoting collateral vessel formation. SVF have the potential to facilitate the formation of new blood vessels and skeletal muscle. Early pilot clinical studies indicate that stem-cell transplantation is feasible and may have beneficial effects in CLI. Injury or inflammation is a prerequisite for the participation of circulating stem cells to home and differentiate on to this microenvironment. The increased vascular permeability and expression of adhesion proteins like integrin assist in stem cell homing. The migratory capacity of stem cells is dependent on natural growth factors such as vascular endothelial growth factor (VEGF), Stromal cell derived factor (SDFI) and stem cell factor (SCF). The expression of VEGF, SDFI and SCF is highly unregulated in the hypoxic muscular tissue and is responsible for the recruitment of the stem cells to assist in the repair mechanism and consequent improvement in limb function.
In addition to the above regenerating potential of SVF, they have several advantages; they can be easily isolated without further culturing it. Most importantly SVF have shown to have significantly highest expression of pluripotent markers similar to that of human embryonic stem cells and yet they are non-tumorogenic and safe.
Read more
MSCs are having angiogenic activity and hence may be excellent source to develop neo-vasculature and hence could be explored for their therapeutic potential for treating Critical Limb Ischemia. MSC's also display membrane-bound and insoluble secreted molecules involved with cell attachment to neighbouring cells and to the extra cellular matrix19 Adipose derived Stromal vascular fraction and Mesenchymal Stem Cells has been found in preclinical studies to be safe and effective.
The current Phase I/II study of adipose derived stromal vascular fraction and Mesenchymal stem cells is conducted with the broad objective of establishing safety and efficacy.
Read the detailed description
Adipose Derived Stromal Vascular Fraction (ADSVF) Stromal Vascular Fraction (SVF) obtained from tumescent liposuction. The SVF contains a variety of cells such as pre-adipocytes, endothelial cells, smooth muscle cells, pericytes, fibroblasts, and adult stem cells (ASCs). In addition, the SVF also contains blood cells from the capillaries supplying the fat cells. These include erythrocytes or red blood cells, B and T cells, macrophages, monocytes, mast cells, natural killer (NK) cells, hematopoietic stem cells and endothelial progenitor cells, to name a few. It also contains growth factors such as transforming growth factor beta (TGF-β), platelet-derived growth factor (PDGF), and fibroblast growth factor (FGF), among others. This is consistent with the secretions of cells in the presence of an extracellular matrix. The SVF also contains the various proteins present in the adipose tissue extracellular matrix of which laminin is of interest due to its ability to help in neural regeneration.Entire procedure for SVF preparation and isolation of SVF cells will be carried out in cGMP compliance clean room.
Pure stromal vascular fraction to the tune of 99% will be isolated for this clinical trial eliminating other unnecessary cells such as RBC and leukocytes.
Adipose Derived Mesenchymal Stem Cells (ADMSC) Human mesenchymal stem cells (MSCs) are present as a rare population of cells in adipose tissue which is almost 30-40% of the nucleated cells, but they can rapidly grow in culture without losing their stemness. MSCs can be expanded in vitro ≥ 2 million -fold and retain their ability to differentiate into several mesenchymal lineages. MSCs have several characteristics such as Ease of isolation, High expansion potential,Genetic stability,Reproducible attributes from isolate to isolate,Reproducible characteristics, Compatibility with tissue engineering principles, Potential to enhance repair in many vital tissues, Uniform dose and Better quality control and release criteria.
Beside autologous use MSC can also be used for allogenic therapy. Several studies have used allo-MSC in vivo and experience suggests that the allo-MSCs are not rejected and many have positive effects on engraftment.MSC's can be isolated from various tissues, cultured ex vivo, and expanded many fold.18 Cultured-expanded MSC's appear to represent a homogeneous population by flow cytometric measures of cell-surface markers. These cell retain the ability to undergo in vitro differentiation to osteogenic, adipogenic and chondrogenic lineages, even when clonally expanded.19 Human adipose tissue derived MSCs are capable of differentiating into endothelial cells in vitro and later form capillary-like structures in semisolid medium and suggest differentiation potential of MSCs is not restricted to mesodermal lineages but also transdifferentiation of MSCs into other lineages like endothelial could be realized in vitro and in vivo8 MSCs are known to give rise to limb-bud mesoderm (osteoblasts, chondrocytes, adipocytes, stroma cells, and skeletal myoblasts) and can also differentiate into cells of visceral mesoderm (endothelial cells).9 MSCs can facilitate vasculogenesis by increasing vascular endothelial growth factor (VEGF) levels. After MSCs are intramyocardially injected into the infarct zone, local VEGF levels rise, vascular density and regional blood flow increases, and contractility improves.
MSCs are having anti-fibrotic activity and hence may be excellent source to tackle pulmonary fibrosis and hence could be explored for their therapeutic potential for treating Idiopathic pulmonary fibrosis. MSC's also display membrane-bound and insoluble secreted molecules involved with cell attachment to neighboring cells and to the extra cellular matrix.18 This cell surface configuration may enable mesenchymal stem cells to home from bloodstream to mesenchymal tissue.
- Conditions
- Critical Limb Ischemia
- Being tested
- Autologous Stromal Vascular Fraction (SVF), Autologous Adipose Derieved MSCs, Control
- Keywords
- CLI
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Stromal Vascular Fraction (SVF)Biological
Also called Autologous Stromal Vascular Fraction
Study arm A subjects will receive single dose of autologous adipose derived Stromal Vascular Fraction (SVF) SVF divided in two fraction and infused intravenously and intramuscularly
Autologous Adipose Derieved MSCsBiological
Study arm B subjects will receive one dose of 1 million per kg body weight adipose tissue derived Ex-vivo expanded Mesenchymal stem cells (MSC) intravenously and one dose of 1 million per kg body weight adipose tissue derived Ex-vivo expanded Mesenchymal stem cells (MSC) intramuscularly
ControlOther
| Study group | Role | What they receive |
|---|---|---|
| Autologous Stromal Vascular Fraction | Experimental | single dose of autologous adipose derived Stromal Vascular Fraction (SVF) SVF divided in two fraction and infused intravenously and intramuscularly Receives: Biological: Autologous Stromal Vascular Fraction (SVF) |
| Autologous Adipose Derived MSCs | Experimental | One dose of 1 million per kg body weight adipose tissue derived Ex-vivo expanded Mesenchymal stem cells (MSC) intravenously and one dose of 1 million per kg body weight adipose tissue derived Ex-vivo expanded Mesenchymal stem cells (MSC) intramuscularly Receives: Biological: Autologous Adipose Derieved MSCs |
| Control | Active comparator | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety
The Incidence of treatment emergent Adverse Event (AE) in the study.
Measured: 9 months
Secondary outcomes (1)
To assess the efficacy
To explore the efficacy by assessing the potential of autologous adipose derived stromal vascular fraction and ex vivo expanded mesenchymal stem cells in alleviating the symptom of Critical Limb Ischemia (CLI)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasiak Research Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Arun B Bal, M.B.B.S.M.S., Principal investigator, SL Raheja HospitalDr. Ashish S Johari, M.B.B.S.M.S., Principal investigator, Jaslok Hospital and Research CentreDr. Meena Kumar, M.B.B.S.M.S., Principal investigator, L T M C and L T M M General Hospital ,SionR Shekhar, M.B.B.S.M.S., Principal investigator, Kokilaben Dhirubai Ambani Hospital and Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145897
- Sponsor's protocol ID
- KRPL/CLI/11-12/001
- Status last verified
- May 2014
- First submitted
- 8 May 2014
- Last updated
- 23 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicentric, Phase I/II, Open Label, Randomized, Interventional Study to Evaluate the Safety and Efficacy of Intramuscular and Intravenous Administration of Autologous ADMSCS for Treatment of Critical Limb Ischemia (CLI).
- ClinicalTrials.gov ID
- NCT02145897
- Acronym / sponsor ID
- KRPL/CLI/11-12/001
- Conditions
- Critical Limb Ischemia
- Keywords
- CLI
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kasiak Research Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Aug 2015 (estimated)
- First posted
- 23 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Various preclinical animal studies have shown the potential of stem cells in re-vascularising ischemic limbs and promoting collateral vessel formation. SVF have the potential to facilitate the formation of new blood vessels and skeletal muscle. Early pilot clinical studies indicate that stem-cell transplantation is feasible and may have beneficial effects in CLI. Injury or inflammation is a prerequisite for the participation of circulating stem cells to home and differentiate on to this microenvironment. The increased vascular permeability and expression of adhesion proteins like integrin assist in stem cell homing. The migratory capacity of stem cells is dependent on natural growth factors such as vascular endothelial growth factor (VEGF), Stromal cell derived factor (SDFI) and stem cell factor (SCF). The expression of VEGF, SDFI and SCF is highly unregulated in the hypoxic muscular tissue and is responsible for the recruitment of the stem cells to assist in the repair mechanism and consequent improvement in limb function.
In addition to the above regenerating potential of SVF, they have several advantages; they can be easily isolated without further culturing it. Most importantly SVF have shown to have significantly highest expression of pluripotent markers similar to that of human embryonic stem cells and yet they are non-tumorogenic and safe.
MSCs are having angiogenic activity and hence may be excellent source to develop neo-vasculature and hence could be explored for their therapeutic potential for treating Critical Limb Ischemia. MSC's also display membrane-bound and insoluble secreted molecules involved with cell attachment to neighbouring cells and to the extra cellular matrix19 Adipose derived Stromal vascular fraction and Mesenchymal Stem Cells has been found in preclinical studies to be safe and effective.
The current Phase I/II study of adipose derived stromal vascular fraction and Mesenchymal stem cells is conducted with the broad objective of establishing safety and efficacy.
Detailed description
Adipose Derived Stromal Vascular Fraction (ADSVF) Stromal Vascular Fraction (SVF) obtained from tumescent liposuction. The SVF contains a variety of cells such as pre-adipocytes, endothelial cells, smooth muscle cells, pericytes, fibroblasts, and adult stem cells (ASCs). In addition, the SVF also contains blood cells from the capillaries supplying the fat cells. These include erythrocytes or red blood cells, B and T cells, macrophages, monocytes, mast cells, natural killer (NK) cells, hematopoietic stem cells and endothelial progenitor cells, to name a few. It also contains growth factors such as transforming growth factor beta (TGF-β), platelet-derived growth factor (PDGF), and fibroblast growth factor (FGF), among others. This is consistent with the secretions of cells in the presence of an extracellular matrix. The SVF also contains the various proteins present in the adipose tissue extracellular matrix of which laminin is of interest due to its ability to help in neural regeneration.Entire procedure for SVF preparation and isolation of SVF cells will be carried out in cGMP compliance clean room.
Pure stromal vascular fraction to the tune of 99% will be isolated for this clinical trial eliminating other unnecessary cells such as RBC and leukocytes.
Adipose Derived Mesenchymal Stem Cells (ADMSC) Human mesenchymal stem cells (MSCs) are present as a rare population of cells in adipose tissue which is almost 30-40% of the nucleated cells, but they can rapidly grow in culture without losing their stemness. MSCs can be expanded in vitro ≥ 2 million -fold and retain their ability to differentiate into several mesenchymal lineages. MSCs have several characteristics such as Ease of isolation, High expansion potential,Genetic stability,Reproducible attributes from isolate to isolate,Reproducible characteristics, Compatibility with tissue engineering principles, Potential to enhance repair in many vital tissues, Uniform dose and Better quality control and release criteria.
Beside autologous use MSC can also be used for allogenic therapy. Several studies have used allo-MSC in vivo and experience suggests that the allo-MSCs are not rejected and many have positive effects on engraftment.MSC's can be isolated from various tissues, cultured ex vivo, and expanded many fold.18 Cultured-expanded MSC's appear to represent a homogeneous population by flow cytometric measures of cell-surface markers. These cell retain the ability to undergo in vitro differentiation to osteogenic, adipogenic and chondrogenic lineages, even when clonally expanded.19 Human adipose tissue derived MSCs are capable of differentiating into endothelial cells in vitro and later form capillary-like structures in semisolid medium and suggest differentiation potential of MSCs is not restricted to mesodermal lineages but also transdifferentiation of MSCs into other lineages like endothelial could be realized in vitro and in vivo8 MSCs are known to give rise to limb-bud mesoderm (osteoblasts, chondrocytes, adipocytes, stroma cells, and skeletal myoblasts) and can also differentiate into cells of visceral mesoderm (endothelial cells).9 MSCs can facilitate vasculogenesis by increasing vascular endothelial growth factor (VEGF) levels. After MSCs are intramyocardially injected into the infarct zone, local VEGF levels rise, vascular density and regional blood flow increases, and contractility improves.
MSCs are having anti-fibrotic activity and hence may be excellent source to tackle pulmonary fibrosis and hence could be explored for their therapeutic potential for treating Idiopathic pulmonary fibrosis. MSC's also display membrane-bound and insoluble secreted molecules involved with cell attachment to neighboring cells and to the extra cellular matrix.18 This cell surface configuration may enable mesenchymal stem cells to home from bloodstream to mesenchymal tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Autologous Stromal Vascular Fraction | Experimental | Biological: Autologous Stromal Vascular Fraction (SVF)single dose of autologous adipose derived Stromal Vascular Fraction (SVF) SVF divided in two fraction and infused intravenously and intramuscularly |
| Autologous Adipose Derived MSCs | Experimental | Biological: Autologous Adipose Derieved MSCsOne dose of 1 million per kg body weight adipose tissue derived Ex-vivo expanded Mesenchymal stem cells (MSC) intravenously and one dose of 1 million per kg body weight adipose tissue derived Ex-vivo expanded Mesenchymal stem cells (MSC) intramuscularly |
| Control | Active comparator | Other: Control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1. Critical limb ischemia (rest pain, un-healing wound/ulcer lasting more than 4 weeks)
- 2. Category 4 \& 5 Rutherford-Becker peripheral vascular disease affecting at least one limb with or without un-healing ulcer/wound of grade I or II on the Wagner scale
- 3. Ankle -brachial index <0.6
- 4. TcpO2 < 45 mm Hg measured at toe
- 5. Life expectancy more than 2 years
Key exclusion criteria (16 listed)
- Uncontrolled high blood pressure
- Uncontrolled diabetes with Glycosylated hemoglobin (HbA1C) > 7%
- Severe cardiac insufficiency (Ejection fraction < 35%)
- Frank infected ulcers with purulent discharge resulting in excessive infections, ulcers with exposed bone, fascia, joints, ligaments or tendons (Category 6 Rutherford-Becker peripheral vascular disease)
- Subject diagnosed with cancer undergoing chemotherapy.
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 Stromal Vascular Fraction (SVF)Also: Autologous Stromal Vascular FractionStudy arm A subjects will receive single dose of autologous adipose derived Stromal Vascular Fraction (SVF) SVF divided in two fraction and infused intravenously and intramuscularly | Biological | Autologous Stromal Vascular Fraction |
| Autologous Adipose Derieved MSCsStudy arm B subjects will receive one dose of 1 million per kg body weight adipose tissue derived Ex-vivo expanded Mesenchymal stem cells (MSC) intravenously and one dose of 1 million per kg body weight adipose tissue derived Ex-vivo expanded Mesenchymal stem cells (MSC) intramuscularly | Biological | Autologous Adipose Derived MSCs |
| Control | Other | Control |
Primary outcome
To assess the safety
Time frame: 9 months
The Incidence of treatment emergent Adverse Event (AE) in the study.
1 secondary outcome
To assess the efficacy
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2014.
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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.
Dr. Arun B Bal, M.B.B.S.M.S. principal investigator
SL Raheja Hospital
Dr. Ashish S Johari, M.B.B.S.M.S. principal investigator
Jaslok Hospital and Research Centre
Dr. Meena Kumar, M.B.B.S.M.S. principal investigator
L T M C and L T M M General Hospital ,Sion
1 site 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 Stromal Vascular Fraction (SVF) and Autologous Adipose Derieved MSCs in people with Critical Limb Ischemia, run by Kasiak Research Pvt. Ltd. at 1 site in India.
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 11 inclusion and 16 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 23 May 2014. 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 India. 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?
Contact Pankaj A Thakur, PhD (+91-(022)-411 73463 ext. 463, pankaj.thakur@kasiakresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety (time frame: 9 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 23 May 2014.