Amyotrophic Lateral SclerosisPhase 1NCT01758510
Safety Study of HLA-haplo Matched Allogenic Bone Marrow Derived Stem Cell Treatment in Amyotrophic Lateral Sclerosis
A Phase 1 study testing HYNR-CS-Allo in people with Amyotrophic Lateral Sclerosis and Motor Neuron Disease, run by Hanyang University Seoul Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the safety of HLA-haplo matched Allogenic Bone Marrow Derived stem cells("HYNR-CS-Allo inj"), through intrathecal delivery for the treatment in patients with amyotrophic lateral sclerosis(ALS). Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Neuromuscular Disease
- What is being tested?
- HYNR-CS-Allo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2012to 10 Apr 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 25 and 80 years old
- Patients who have both signs of lower motor neuron(LMN) and upper motor neuron(UMN) degeneration by clinical, electrophysiological or neuropathologic examination
- Patients diagnosed as 'Probable' or 'Definite' ALS according to the World Federation of Neurology El Escorial criteria
- Patients whose duration of disease is within 5 years from the first diagnosis
- Patients with ALSFRS-R score within 21 to 46 at screening
- Patients who can visit to a hospital by walk personally or by protector's help
- Patients who provide the written consent by oneself or his/her legal representative
- Patients who has HLA-haplo matched Bone marrow donor
Who cannot join
- Patients who doesn't appropriate to the diagnostic criteria of ALS
- Patients who are diagnosed as primary lateral sclerosis(PLS) or progressive muscular atrophy(PMA)
- Patients suspected of adverse effect after stem cell injection(patients suspected of malignant tumor, risk group of psychogenic shock, patients with serious hypertension)
- Patients with ALSFRS-R score below 21 at screening
- Patients performed ventilator or tracheostomy at screening
- Patients performed gastrostomy at screening
Show all 21Show fewer
- Patients unable to assess the efficacy of this clinical trial due to unattainable Pulmonary Functional Test(PFT) or patients with suspected 40% or less of Forced vital capacity(FVC) at screening
- Patients with finding of myocardial infarction or angina pectoris according to ECG, patients who have been performed Stenting or Bypass operation at screening
- Patients who have taken any other drug for clinical trial within the past 3 months at screening entry
- Patients with epilepsy
- Patients with severe renal dysfunction(serum creatinine≥2.0mg/dl)
- Patients with severe liver dysfunction(ALT, AST, bilirubin≥upper limit of normal X 2)
- Pregnant woman, lactating woman, female patients who has a pregnancy planning or who doesn't agree with adoption of contraception methods proper medically, male patients who doesn't agree with adoption of contraception methods proper to his partner during participating this study
- Patients with hemorrhagic tendency at screening
- Patients with virus infection at screening
- Patients with a known history of hypersensitivity/allergy to penicillin and streptomycin
- Patients with previous stem cell therapy
- Patients diagnosed with cancer
- Patients who have taken any drug that can effect to bone marrow function
- Patients with any other neurological disease except ALS
- Patients with psychotic diseases
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hanyang University Seoul Hospital, Cell Therapy Center for Neurologic Disorders
Seoul, Haengdang-dong, Seongdong-gu, 133-792
About this study
Official title: An Open-label, Phase 1 Trial for Safety Study of HLA-haplo Matched Allogenic Bone Marrow Derived Stem Cell("HYNR-CS-Allo Inj") Treatment in Amyotrophic Lateral Sclerosis(ALS)
The purpose of this study is to evaluate the safety of HLA-haplo matched Allogenic Bone Marrow Derived stem cells("HYNR-CS-Allo inj"), through intrathecal delivery for the treatment in patients with amyotrophic lateral sclerosis(ALS).
This study is an open label, dose up and down study using the 3+3 design to assess the safety of HLA-haplo matched Allogenic Bone Marrow Derived stem cells("HYNR-CS-Allo inj")
Read the detailed description
Amyotrophic lateral sclerosis is a progressive neurodegenerative disease characterized by motor neuron loss. Despite of many trials for disease-modifying, no treatment has so far changed natural course of disease.
The investigators had performed the pre-clinical and clinical studies using autologous bone marrow-derived stem cells in ALS. In the investigators' results of clinical trial, intrathecal injection of autologous bone marrow-derived stem cells is safe and could slow down disease progression and might be used as a disease modifying strategy in patients with ALS.
In the new field, like cell therapy, it is an important issue whether a bone marrow derived mesenchymal stem cells can be used as an allograft. Many investigators had showed that the immunoprivileged and immunosuppressive properties of mesenchymal stem cells result from the absence of major histocompatibility class II antigens and the secretion of T helper type 2 cytokines.
One potential advantage of allogenic bone marrow derived cells could be avoiding the need for procedural delay before treatment. And it is also hypothesized that the function of autologous bone marrow derived cells could be impaired in patients with co-morbidities or advanced age.
This study is to evaluate safety of HYNR-CS-Allo inj(HLA-haplo matched Allogenic bone marrow-derived stem cells) in patients with ALS.
The patients enrolled in the trial will be successively allocated into three cohorts for HYNR-CS-Allo inj., 0.25 X 10^6 cells/kg, 0.5 X 10^6 cells/kg, 1 X 10^6 cells/kg, according to the 3+3, up and down protocol design. The first treatment cohort will be 0.5 X 106 cells/kg dose cohort. Only a maximum of six patients will be given a particular dosage.
The scheduled assessments and visits will be carried out over three periods: run-in period, treatment period, and follow-up period.
The run-in period includes the screening visit where a written informed consent is obtained and the screening period where patients are assessed for eligibility. It will be completed within 30 days prior to enrollment. The patients meeting inclusion criteria will start the treatment period.
During the treatment period, subjects will be administered HYNR-CS-Allo inj. 2 times by intrathecal administration with 28 days interval.
The Follow-up period starts once subjects complete the treatment period and will continue until the final follow-up visit.
- Conditions
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Neuromuscular Disease, Neurodegenerative Disease, Central Nervous System Disease
- Being tested
- HYNR-CS-Allo
- Keywords
- Amyotrophic Lateral Sclerosis, ALS, Neurodegenerative disease, Motor Neuron Disease, Central Nervous System Disease, Neuromuscular Disease, Bone marrow derived stem cell, stem cell therapy, intrathecal injection
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Neuromuscular Diseases, Neurodegenerative Diseases, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HYNR-CS-AlloGenetic
The patients enrolled in the trial will be successively allocated into three cohorts for HYNR-CS-Allo inj., 0.25 X 10^6 cells/kg, 0.5 X 10^6 cells/kg, 1 X 10^6 cells/kg, according to the 3+3, up and down protocol design. The first treatment cohort will be 0.5 X 10^6 cells/kg dose cohort.
| Study group | Role | What they receive |
|---|---|---|
| HYNR-CS-Allo | Experimental | HYNR-CS-Allo inj. 2 times by intrathecal administration with 28 days interval. Receives: Genetic: HYNR-CS-Allo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Events(SAE)
The Incidence of any treatment related serious adverse events(SAE)
Measured: 6 months
Secondary outcomes (2)
ALS-Functional rating scales(ALS-FRS)
Changes in ALS-Functional rating scales(ALS-FRS)
Measured: 6 months
Adverse Events(AE)
Incidence \& Degree of Adverse Events(AE)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startDec 2012
- Primary completion10 Apr 2017
- Study completion10 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanyang University Seoul Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Corestemchemon, Inc.
- Responsible party
- Principal investigator, Seung Hyun Kim, Hanyang University Seoul Hospital
- Investigators
- Seung Hyun Kim, M.D., Ph.D, Principal investigator, Hanyang University Seoul Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758510
- Sponsor's protocol ID
- HYNR-CS-Allo-01
- Status last verified
- May 2019
- First submitted
- 10 Dec 2012
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kwon MJ, Baek W, Ki CS, Kim HY, Koh SH, Kim JW, Kim SH. Screening of the SOD1, FUS, TARDBP, ANG, and OPTN mutations in Korean patients with familial and sporadic ALS. Neurobiol Aging. 2012 May;33(5):1017.e17-23. doi: 10.1016/j.neurobiolaging.2011.12.003. Epub 2012 Jan 15.
PubMed 22244934Koh SH, Baik W, Noh MY, Cho GW, Kim HY, Kim KS, Kim SH. The functional deficiency of bone marrow mesenchymal stromal cells in ALS patients is proportional to disease progression rate. Exp Neurol. 2012 Jan;233(1):472-80. doi: 10.1016/j.expneurol.2011.11.021. Epub 2011 Nov 19.
PubMed 22119626Koh SH, Huh YM, Noh MY, Kim HY, Kim KS, Lee ES, Ko HJ, Cho GW, Yoo AR, Song HT, Hwang S, Lee K, Haam S, Frank JA, Suh JS, Kim SH. beta-PIX is critical for transplanted mesenchymal stromal cell migration. Stem Cells Dev. 2012 Jul 20;21(11):1989-99. doi: 10.1089/scd.2011.0430. Epub 2012 Jan 26.
PubMed 22087847Choi MR, Kim HY, Park JY, Lee TY, Baik CS, Chai YG, Jung KH, Park KS, Roh W, Kim KS, Kim SH. Selection of optimal passage of bone marrow-derived mesenchymal stem cells for stem cell therapy in patients with amyotrophic lateral sclerosis. Neurosci Lett. 2010 Mar 19;472(2):94-8. doi: 10.1016/j.neulet.2010.01.054. Epub 2010 Feb 1.
PubMed 20117176Cho GW, Noh MY, Kim HY, Koh SH, Kim KS, Kim SH. Bone marrow-derived stromal cells from amyotrophic lateral sclerosis patients have diminished stem cell capacity. Stem Cells Dev. 2010 Jul;19(7):1035-42. doi: 10.1089/scd.2009.0453.
PubMed 20030561Kim H, Kim HY, Choi MR, Hwang S, Nam KH, Kim HC, Han JS, Kim KS, Yoon HS, Kim SH. Dose-dependent efficacy of ALS-human mesenchymal stem cells transplantation into cisterna magna in SOD1-G93A ALS mice. Neurosci Lett. 2010 Jan 14;468(3):190-4. doi: 10.1016/j.neulet.2009.10.074. Epub 2009 Oct 29.
PubMed 19879334Kwon MS, Noh MY, Oh KW, Cho KA, Kang BY, Kim KS, Kim YS, Kim SH. The immunomodulatory effects of human mesenchymal stem cells on peripheral blood mononuclear cells in ALS patients. J Neurochem. 2014 Oct;131(2):206-18. doi: 10.1111/jnc.12814. Epub 2014 Jul 31.
PubMed 24995608Oh KW, Moon C, Kim HY, Oh SI, Park J, Lee JH, Chang IY, Kim KS, Kim SH. Phase I trial of repeated intrathecal autologous bone marrow-derived mesenchymal stromal cells in amyotrophic lateral sclerosis. Stem Cells Transl Med. 2015 Jun;4(6):590-7. doi: 10.5966/sctm.2014-0212. Epub 2015 May 1.
PubMed 25934946Kim HY, Kim H, Oh KW, Oh SI, Koh SH, Baik W, Noh MY, Kim KS, Kim SH. Biological markers of mesenchymal stromal cells as predictors of response to autologous stem cell transplantation in patients with amyotrophic lateral sclerosis: an investigator-initiated trial and in vivo study. Stem Cells. 2014 Oct;32(10):2724-31. doi: 10.1002/stem.1770.
PubMed 24966156
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase 1 Trial for Safety Study of HLA-haplo Matched Allogenic Bone Marrow Derived Stem Cell("HYNR-CS-Allo Inj") Treatment in Amyotrophic Lateral Sclerosis(ALS)
- ClinicalTrials.gov ID
- NCT01758510
- Acronym / sponsor ID
- HYNR-CS-Allo-01
- Conditions
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Neuromuscular Disease, Neurodegenerative Disease, Central Nervous System Disease
- Keywords
- Amyotrophic Lateral Sclerosis, ALS, Neurodegenerative disease, Motor Neuron Disease, Central Nervous System Disease, Neuromuscular Disease, Bone marrow derived stem cell, stem cell therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Hanyang University Seoul HospitalUniversity, hospital or other
- Collaborators
- Corestemchemon, Inc.
- Study start
- Dec 2012 (actual)
- Primary completion
- 10 Apr 2017 (actual)
- Study completion
- 10 Apr 2017 (actual)
- First posted
- 1 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety of HLA-haplo matched Allogenic Bone Marrow Derived stem cells("HYNR-CS-Allo inj"), through intrathecal delivery for the treatment in patients with amyotrophic lateral sclerosis(ALS).
This study is an open label, dose up and down study using the 3+3 design to assess the safety of HLA-haplo matched Allogenic Bone Marrow Derived stem cells("HYNR-CS-Allo inj")
Detailed description
Amyotrophic lateral sclerosis is a progressive neurodegenerative disease characterized by motor neuron loss. Despite of many trials for disease-modifying, no treatment has so far changed natural course of disease.
The investigators had performed the pre-clinical and clinical studies using autologous bone marrow-derived stem cells in ALS. In the investigators' results of clinical trial, intrathecal injection of autologous bone marrow-derived stem cells is safe and could slow down disease progression and might be used as a disease modifying strategy in patients with ALS.
In the new field, like cell therapy, it is an important issue whether a bone marrow derived mesenchymal stem cells can be used as an allograft. Many investigators had showed that the immunoprivileged and immunosuppressive properties of mesenchymal stem cells result from the absence of major histocompatibility class II antigens and the secretion of T helper type 2 cytokines.
One potential advantage of allogenic bone marrow derived cells could be avoiding the need for procedural delay before treatment. And it is also hypothesized that the function of autologous bone marrow derived cells could be impaired in patients with co-morbidities or advanced age.
This study is to evaluate safety of HYNR-CS-Allo inj(HLA-haplo matched Allogenic bone marrow-derived stem cells) in patients with ALS.
The patients enrolled in the trial will be successively allocated into three cohorts for HYNR-CS-Allo inj., 0.25 X 10^6 cells/kg, 0.5 X 10^6 cells/kg, 1 X 10^6 cells/kg, according to the 3+3, up and down protocol design. The first treatment cohort will be 0.5 X 106 cells/kg dose cohort. Only a maximum of six patients will be given a particular dosage.
The scheduled assessments and visits will be carried out over three periods: run-in period, treatment period, and follow-up period.
The run-in period includes the screening visit where a written informed consent is obtained and the screening period where patients are assessed for eligibility. It will be completed within 30 days prior to enrollment. The patients meeting inclusion criteria will start the treatment period.
During the treatment period, subjects will be administered HYNR-CS-Allo inj. 2 times by intrathecal administration with 28 days interval.
The Follow-up period starts once subjects complete the treatment period and will continue until the final follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HYNR-CS-Allo | Experimental | Genetic: HYNR-CS-AlloHYNR-CS-Allo inj. 2 times by intrathecal administration with 28 days interval. |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients between 25 and 80 years old
- Patients who have both signs of lower motor neuron(LMN) and upper motor neuron(UMN) degeneration by clinical, electrophysiological or neuropathologic examination
- Patients diagnosed as 'Probable' or 'Definite' ALS according to the World Federation of Neurology El Escorial criteria
- Patients whose duration of disease is within 5 years from the first diagnosis
- Patients with ALSFRS-R score within 21 to 46 at screening
Key exclusion criteria (21 listed)
- Patients who doesn't appropriate to the diagnostic criteria of ALS
- Patients who are diagnosed as primary lateral sclerosis(PLS) or progressive muscular atrophy(PMA)
- Patients suspected of adverse effect after stem cell injection(patients suspected of malignant tumor, risk group of psychogenic shock, patients with serious hypertension)
- Patients with ALSFRS-R score below 21 at screening
- Patients performed ventilator or tracheostomy at screening
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 |
|---|---|---|
| HYNR-CS-AlloThe patients enrolled in the trial will be successively allocated into three cohorts for HYNR-CS-Allo inj., 0.25 X 10^6 cells/kg, 0.5 X 10^6 cells/kg, 1 X 10^6 cells/kg, according to the 3+3, up and down protocol design. The first treatment cohort will be 0.5 X 10^6 cells/kg dose cohort. | Genetic | HYNR-CS-Allo |
Primary outcome
Serious Adverse Events(SAE)
Time frame: 6 months
The Incidence of any treatment related serious adverse events(SAE)
2 secondary outcomes
ALS-Functional rating scales(ALS-FRS)
Time frame: 6 months
Adverse Events(AE)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2019.
- Background: PubMed 22244934Kwon MJ, Baek W, Ki CS, Kim HY, Koh SH, Kim JW, Kim SH. Screening of the SOD1, FUS, TARDBP, ANG, and OPTN mutations in Korean patients with familial and sporadic ALS. Neurobiol Aging. 2012 May;33(5):1017.e17-23. doi: 10.1016/j.neurobiolaging.2011.12.003. Epub 2012 Jan 15.
- Background: PubMed 22119626Koh SH, Baik W, Noh MY, Cho GW, Kim HY, Kim KS, Kim SH. The functional deficiency of bone marrow mesenchymal stromal cells in ALS patients is proportional to disease progression rate. Exp Neurol. 2012 Jan;233(1):472-80. doi: 10.1016/j.expneurol.2011.11.021. Epub 2011 Nov 19.
- Background: PubMed 22087847Koh SH, Huh YM, Noh MY, Kim HY, Kim KS, Lee ES, Ko HJ, Cho GW, Yoo AR, Song HT, Hwang S, Lee K, Haam S, Frank JA, Suh JS, Kim SH. beta-PIX is critical for transplanted mesenchymal stromal cell migration. Stem Cells Dev. 2012 Jul 20;21(11):1989-99. doi: 10.1089/scd.2011.0430. Epub 2012 Jan 26.
- Background: PubMed 20117176Choi MR, Kim HY, Park JY, Lee TY, Baik CS, Chai YG, Jung KH, Park KS, Roh W, Kim KS, Kim SH. Selection of optimal passage of bone marrow-derived mesenchymal stem cells for stem cell therapy in patients with amyotrophic lateral sclerosis. Neurosci Lett. 2010 Mar 19;472(2):94-8. doi: 10.1016/j.neulet.2010.01.054. Epub 2010 Feb 1.
- Background: PubMed 20030561Cho GW, Noh MY, Kim HY, Koh SH, Kim KS, Kim SH. Bone marrow-derived stromal cells from amyotrophic lateral sclerosis patients have diminished stem cell capacity. Stem Cells Dev. 2010 Jul;19(7):1035-42. doi: 10.1089/scd.2009.0453.
- Background: PubMed 19879334Kim H, Kim HY, Choi MR, Hwang S, Nam KH, Kim HC, Han JS, Kim KS, Yoon HS, Kim SH. Dose-dependent efficacy of ALS-human mesenchymal stem cells transplantation into cisterna magna in SOD1-G93A ALS mice. Neurosci Lett. 2010 Jan 14;468(3):190-4. doi: 10.1016/j.neulet.2009.10.074. Epub 2009 Oct 29.
- Background: PubMed 24995608Kwon MS, Noh MY, Oh KW, Cho KA, Kang BY, Kim KS, Kim YS, Kim SH. The immunomodulatory effects of human mesenchymal stem cells on peripheral blood mononuclear cells in ALS patients. J Neurochem. 2014 Oct;131(2):206-18. doi: 10.1111/jnc.12814. Epub 2014 Jul 31.
- Background: PubMed 25934946Oh KW, Moon C, Kim HY, Oh SI, Park J, Lee JH, Chang IY, Kim KS, Kim SH. Phase I trial of repeated intrathecal autologous bone marrow-derived mesenchymal stromal cells in amyotrophic lateral sclerosis. Stem Cells Transl Med. 2015 Jun;4(6):590-7. doi: 10.5966/sctm.2014-0212. Epub 2015 May 1.
- Background: PubMed 24966156Kim HY, Kim H, Oh KW, Oh SI, Koh SH, Baik W, Noh MY, Kim KS, Kim SH. Biological markers of mesenchymal stromal cells as predictors of response to autologous stem cell transplantation in patients with amyotrophic lateral sclerosis: an investigator-initiated trial and in vivo study. Stem Cells. 2014 Oct;32(10):2724-31. doi: 10.1002/stem.1770.
- collaborator and stem cell providerLink provided by the sponsor.
- Hanyang University Medical centerLink provided by the sponsor.
- home page of dementia center in Seoul Seongdong-guLink 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.
Seung Hyun Kim, M.D., Ph.D principal investigator
Hanyang University Seoul Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HYNR-CS-Allo in people with Amyotrophic Lateral Sclerosis and Motor Neuron Disease, run by Hanyang University Seoul Hospital at 1 site in South Korea.
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 8 inclusion and 21 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 16 May 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 South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Adverse Events(SAE) (time frame: 6 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 NCT01758510, which also lists 9 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 16 May 2019.