Amyotrophic Lateral SclerosisPhase 1/2NCT01363401

Safety and Efficacy Study of Autologous Bone Marrow Derived Stem Cell Treatment in Amyotrophic Lateral Sclerosis

A Phase 1/2 study testing HYNR-CS inj in people with Amyotrophic Lateral Sclerosis and ALS, run by Corestemchemon, Inc. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the safety and efficacy of autologous bone marrow-derived stem cells("HYNR-CS inj"), through intrathecal delivery for the treatment in patients with ALS. This study consists of 2 steps. Read more about this study

Who is it for?: Ages 25 to 75 years
Conditions the study is for: Amyotrophic Lateral Sclerosis, ALS
What is being tested?: HYNR-CS inj
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteSouth Korea
Study dates: Feb 2011to Aug 2013
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients between 25 and 75 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 who have taken Rilutek at stable background dose from 3 months ago at least before screening entry
Patients whose duration of disease is within 5 years from the first diagnosis
Patients with ALSFRS-R score within 31 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

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 30 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 PFT(Pulmonary Functional Test) or patients with suspected 40% or less of 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 thag 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 Hospital
Seoul, 133-792

Other trials in South Korea

About this study

Official title: An Open-label, Phase I/II Trial for Safety and Efficacy Study of Autologous Bone Marrow Derived Stem Cell Treatment in Amyotrophic Lateral Sclerosis

The purpose of this study is to evaluate the safety and efficacy of autologous bone marrow-derived stem cells("HYNR-CS inj"), through intrathecal delivery for the treatment in patients with ALS.

This study consists of 2 steps. First step is a safety study of the intrathecal(IT) injection of "HYNR-CS inj" in 8 patients with ALS. In this phase 1 study, AE, laboratory test, physical examination, vital signs, Electrocardiogram, and Chest X-Ray examination were evaluated in terms of safety.

Second step is to compare the efficacy and safety between test group and control group of total 64 patients with ALS.

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.

We have performed the pre-clinical and clinical studies using autologous bone marrow-derived stem cells in ALS. We could get the evidence that autologous bone marrow-derived stem cells have dose-dependent effects on SOD1 mice via intrathecal injection. In our results of clinical trial, intrathecal injection of autologous bone marrow-derived stem cells could slow down disease progression and might be used as a disease modifying strategy in patients with ALS.

This study was designed as a single center, randomized, open-label, parallel-group, 2-stage study, and targeted at patients diagnosed with Amyotrophic Lateral Sclerosis(Lou Gehrig's disease). The study consisted of Stage-1 study for safety evaluation and Stage-2 study for efficacy and safety evaluation of the study drug, and at Stage 1, 7 subjects eligible for the inclusion/exclusion criteria received safety evaluation for 28 days of study drug administration in twice under the protocol, and then followed Stage 2. To decide whether the study can be proceeded in 2 stages, ADR(CTCAE Version 3.0, ≥grade 3) should not appear in initial 7 subjects.

Data obtained from subjects of this study were analyzed into three: Safety Analysis, ITT(Intent-To-Treat) Analysis, and PP(Per Protocol) Analysis. However, in case of phase 1, only safety analysis was conducted, and in case of phase 2, all of safety, ITT, and PP analyses were conducted.

For ITT Analysis, all the subjects whose data on primary efficacy endpoint could be obtained following the administration of investigational drug were analyzed in analysis among subjects who were administered the investigational drug once at least. Also, Modified ITT Analysis, including 7 subjects at Stage 1, was carried out.

Conditions: Amyotrophic Lateral Sclerosis, ALS
Being tested: HYNR-CS inj, Control group
Keywords: Amyotrophic lateral sclerosis, ALS, Motor neuron disease, MND, HYNR-CS inj, Autologous bone marrow derived stem cell, Intrathecal injection
Medical subject headings: Amyotrophic Lateral Sclerosis, Motor Neuron Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HYNR-CS injBiological
Intrathecal injection with 1ml/10kg of body weight at an interval of 26 days.
Control groupOther
No treatment of HYNR-CS inj

Study groups in NCT01363401
Study group	Role	What they receive
Test group	Experimental	Treatment group with HYNR-CS inj. Receives: Biological: HYNR-CS inj
Control group	Experimental	No treatment with HYNR-CS inj. Receives: Other: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

The Difference in the Changes of Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) Between Treatment Groups and Control Groups.
ALSFRS-R is ordinal rating scale questionnaire (rating 0-4 for each question, 4 is most functional, 0-48 total) of 12 functional activities. The most functional total score is 48. ALSFRS-R was evaluated at baseline and week 28.(The first injection was performed at 0 week) ALSFRS-R total score variation baseline(Visit 5) and week 16(Visit 9)
Measured: baseline(Visit 5) and week 16(Visit 9)

Secondary outcomes (3)

Change in Appel Scale
To evaluate the disease change, Appel scale will be assessed. Appel scale is a test tool, which is devised to evaluate the functional condition and variation of ALS(Lou Gehrig's disease) patients (rating 6 to between 30 and 36 points for each of 5 functional conditions, 30-164 total).
The higher the total score presents more severe disability. This was done at Visit 1, Visit 5 and Visit 9 (week -12,0,16). The first injection was performed at 0 week(Visit 5) Appel scale total score variation baseline(Visit 5) and week 16(Visit 9)
Measured: baseline(Visit 5) and week 16(Visit 9)
Change in Forced Vital Capacity (FVC) (Percent of Predicted Normal)
Secondary efficacy was measured by comparing the rate of decline of mean FVC by treatment group.
FVC which is a clinical scale to observe variation in patient's respiratory competence, was conducted at Visit 1, Visit 5 and Visit 9. (week -12,0,16) The first injection was performed at 0 week. FVC variation baseline(Visit 5) and week 16(Visit 9)
Measured: baseline(Visit 5) and week 16(Visit 9)
Change in SF-36 (The Short Form (36) Health Survey is a 36 Item)
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score presents more severe disability. The higher the score presents less disability.
This was measured at Visit 5 and Visit 9. (week 0,16) The first injection was performed at 0 week.
The score variation baseline(Visit 5) and week 16(Visit 9)
Measured: baseline(Visit 5) and week 16(Visit 9)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2011Aug 2013

First posted1 Jun 2011 (estimated)
Study startFeb 2011
Primary completionMay 2013
Study completionAug 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01363401
Sponsor's protocol ID: HYNR_CS_ALS201
Status last verified: Sep 2018
First submitted: 30 May 2011
Last updated: 17 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Kim 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 19879334
Choi 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 20117176
Kim 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
Oh 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 25934946
Oh KW, Noh MY, Kwon MS, Kim HY, Oh SI, Park J, Kim HJ, Ki CS, Kim SH. Repeated Intrathecal Mesenchymal Stem Cells for Amyotrophic Lateral Sclerosis. Ann Neurol. 2018 Sep;84(3):361-373. doi: 10.1002/ana.25302. Epub 2018 Aug 31.
PubMed 30048006

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Amyotrophic Lateral Sclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Phase I/II Trial for Safety and Efficacy Study of Autologous Bone Marrow Derived Stem Cell Treatment in Amyotrophic Lateral Sclerosis
ClinicalTrials.gov ID: NCT01363401
Acronym / sponsor ID: HYNR_CS_ALS201
Conditions: Amyotrophic Lateral Sclerosis, ALS
Keywords: Amyotrophic lateral sclerosis, ALS, Motor neuron disease, MND, HYNR-CS inj, Autologous bone marrow derived stem cell, Intrathecal injection
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Corestemchemon, Inc.Industry (pharma, biotech, devices)
Study start: Feb 2011
Primary completion: May 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 1 Jun 2011 (estimated)
Results: Posted 20 Jul 2016

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 and efficacy of autologous bone marrow-derived stem cells("HYNR-CS inj"), through intrathecal delivery for the treatment in patients with ALS.

Second step is to compare the efficacy and safety between test group and control group of total 64 patients with ALS.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Test group	Experimental	Biological: HYNR-CS injTreatment group with HYNR-CS inj.
Control group	Experimental	Other: Control groupNo treatment with HYNR-CS inj.

Who may qualify

Ages: 25 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Patients between 25 and 75 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 who have taken Rilutek at stable background dose from 3 months ago at least before screening entry
Patients whose duration of disease is within 5 years from the first diagnosis

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 30 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 injIntrathecal injection with 1ml/10kg of body weight at an interval of 26 days.	Biological	Test group
Control groupNo treatment of HYNR-CS inj	Other	Control group

Primary outcome

The Difference in the Changes of Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) Between Treatment Groups and Control Groups.
Time frame: baseline(Visit 5) and week 16(Visit 9)
ALSFRS-R is ordinal rating scale questionnaire (rating 0-4 for each question, 4 is most functional, 0-48 total) of 12 functional activities. The most functional total score is 48. ALSFRS-R was evaluated at baseline and week 28.(The first injection was performed at 0 week) ALSFRS-R total score variation baseline(Visit 5) and week 16(Visit 9)

3 secondary outcomes

Change in Appel Scale
Time frame: baseline(Visit 5) and week 16(Visit 9)
Change in Forced Vital Capacity (FVC) (Percent of Predicted Normal)
Time frame: baseline(Visit 5) and week 16(Visit 9)
Change in SF-36 (The Short Form (36) Health Survey is a 36 Item)
Time frame: baseline(Visit 5) and week 16(Visit 9)

Results and safety

Results posted to the registry on 20 Jul 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HYNR-CS Inj.	41	39
No Treatment	31	27

Primary outcome: The Difference in the Changes of Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) Between Treatment Groups and Control Groups.

Time frame: baseline(Visit 5) and week 16(Visit 9). Mean (Standard Deviation). Unit: score on a scale

Measure	HYNR-CS Inj. n = 39	No Treatment n = 27
Value	-1.36 (2.39)	-4.67 (3.25)

Population analysed: The ALSFRS-R score was assessed by all the subjects in Phase 1/2 clinical trials.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected for the duration of the study period: March 2011 to May 2013. Each subject was followed for AEs from consent signing to the end of their study participation.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HYNR-CS Inj.	3 of 41 (7.3%)	28 of 41 (68.3%)	Not reported
No Treatment	3 of 31 (9.7%)	22 of 31 (71%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 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 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.
Results publication: 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.
Results publication: PubMed 30048006Oh KW, Noh MY, Kwon MS, Kim HY, Oh SI, Park J, Kim HJ, Ki CS, Kim SH. Repeated Intrathecal Mesenchymal Stem Cells for Amyotrophic Lateral Sclerosis. Ann Neurol. 2018 Sep;84(3):361-373. doi: 10.1002/ana.25302. Epub 2018 Aug 31.
Hanyang University Medical CenterLink provided by the sponsor.
Corestem Inc.Link provided by the sponsor.
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.

Seung Hyun Kim, M.D., Ph.D. principal investigator

Hanyang University

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 HYNR-CS inj in people with Amyotrophic Lateral Sclerosis and ALS, run by Corestemchemon, Inc. 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 17 Mar 2022. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Difference in the Changes of Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) Between Treatment Groups and Control Groups. (time frame: baseline(Visit 5) and week 16(Visit 9)). 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 NCT01363401, which also lists 5 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 17 Mar 2022.