Amyotrophic Lateral SclerosisNCT00801333
Derivation of Induced Pluripotent Stem Cells From an Existing Collection of Human Somatic Cells
An observational study of Amyotrophic Lateral Sclerosis, run by Hadassah Medical Organization at 2 sites in Israel.
Trial summary
Induced pluripotent stem cells potentially may be useful in the future as an unlimited source of cells for transplantation. The major goal of the project is to develop human iPS cells from various types of cell cultures or lines from existing collections. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- How many people
- 25 participants
- Where
- 2 sitesIsrael
- Study dates
- Nov 2008to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We will use human somatic cells from existing collections.
Who may be able to join
- Volunteers
- Male and Female
Who cannot join
- Below the official age of consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Israel2 sites, 2 recruiting
- Recruiting
Hadassah Medical Organization - Ein Kerem Campus
Jerusalem, 91120
Hadas Lemberg, PhD, 011-972-2-677-6095, Lhadas@hadassah.org.il
- Recruiting
Hadassah Ein Kerem
Jerusalem, 9112100
Benjamin E Reubinoff, Professor, 972-2-6776424/5, benr@hadassah.org.il
Shelly E Tannenbaum, MSQA, 972-2-6777945, stannenbaum@hadassah.org.il
About this study
Induced pluripotent stem cells potentially may be useful in the future as an unlimited source of cells for transplantation.
The major goal of the project is to develop human iPS cells from various types of cell cultures or lines from existing collections. The IPS cells will be developed for modeling diseases, for developing the technology that may eventually allow the use of IPS cells for transplantation therapy, and for basic research.
Read the detailed description
The potential to reprogram somatic cells into an embryonic state raises multiple basic research questions related both to the process of reprogramming and the properties of iPS cells. We will use various approaches to study the molecular mechanisms and processes that occur during reprogramming. We will use various experimental systems to characterize and study the properties of the iPS cells, their biology, developmental potential, capability to give rise to functional differentiated progeny etc.
We will induce the differentiation of the iPS cells towards specific cell lineages and the progeny can be used to study the pathogenesis of diseases. They will be used for developing new therapeutic approaches and for high throughput screening of factors for potential toxic or therapeutic effects.
All samples will be non-identified.
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- ALS
- Medical subject headings
- Amyotrophic Lateral Sclerosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Reubinoff, Hadassah Medical Organization
- Investigators
- Benjamin E Reubinoff, MD PhD, Principal investigator, Chairman of Department of Obstetrics & Gynecology/IVF, Hadassah Ein Kerem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801333
- Sponsor's protocol ID
- 0511-08-HMO
- Status last verified
- Mar 2025
- First submitted
- 2 Dec 2008
- Last updated
- 5 Mar 2025
- Results posted
- No
Publications
Dimos JT, Rodolfa KT, Niakan KK, Weisenthal LM, Mitsumoto H, Chung W, Croft GF, Saphier G, Leibel R, Goland R, Wichterle H, Henderson CE, Eggan K. Induced pluripotent stem cells generated from patients with ALS can be differentiated into motor neurons. Science. 2008 Aug 29;321(5893):1218-21. doi: 10.1126/science.1158799. Epub 2008 Jul 31.
PubMed 18669821
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Derivation of Induced Pluripotent Stem Cells From an Existing Collection of Human Somatic Cells
- ClinicalTrials.gov ID
- NCT00801333
- Acronym / sponsor ID
- 0511-08-HMO
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- ALS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Nov 2008 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 3 Dec 2008 (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.
Induced pluripotent stem cells potentially may be useful in the future as an unlimited source of cells for transplantation.
The major goal of the project is to develop human iPS cells from various types of cell cultures or lines from existing collections. The IPS cells will be developed for modeling diseases, for developing the technology that may eventually allow the use of IPS cells for transplantation therapy, and for basic research.
Detailed description
The potential to reprogram somatic cells into an embryonic state raises multiple basic research questions related both to the process of reprogramming and the properties of iPS cells. We will use various approaches to study the molecular mechanisms and processes that occur during reprogramming. We will use various experimental systems to characterize and study the properties of the iPS cells, their biology, developmental potential, capability to give rise to functional differentiated progeny etc.
We will induce the differentiation of the iPS cells towards specific cell lineages and the progeny can be used to study the pathogenesis of diseases. They will be used for developing new therapeutic approaches and for high throughput screening of factors for potential toxic or therapeutic effects.
All samples will be non-identified.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We will use human somatic cells from existing collections.
Key inclusion criteria (2 listed)
- Volunteers
- Male and Female
Key exclusion criteria (1 listed)
- Below the official age of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Background: PubMed 18669821Dimos JT, Rodolfa KT, Niakan KK, Weisenthal LM, Mitsumoto H, Chung W, Croft GF, Saphier G, Leibel R, Goland R, Wichterle H, Henderson CE, Eggan K. Induced pluripotent stem cells generated from patients with ALS can be differentiated into motor neurons. Science. 2008 Aug 29;321(5893):1218-21. doi: 10.1126/science.1158799. Epub 2008 Jul 31.
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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.
Benjamin E Reubinoff, MD PhD principal investigator
Chairman of Department of Obstetrics & Gynecology/IVF, Hadassah Ein Kerem
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis, run by Hadassah Medical Organization at 2 sites in Israel.
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 1 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: looking for participants now, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin E. Reubinoff, M.D. PhD. (011-972-2-677-4569, benjaminr@ekmd.huji.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00801333, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.