Neurodegenerative DisordersNCT00874783
Development of IPS from Donated Somatic Cells of Patients with Neurological Diseases
An observational study of Neurodegenerative Disorders, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Human fibroblasts and possibly other human somatic cells may be reprogrammed into induced pluripotent stem (iPS) cells by the forced expression of transcription factors (1-5). The iPS cells seem to share many properties with human embryonic stem cells. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neurodegenerative Disorders
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2009to 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: 120 donors to cover 10 different neurodegenerative disorders (previously specified) based on 10 donors per disorder and 20 healthy control donors.
Who may be able to join
- Donors suffering from different (specified) neurodegenerative disorders scheduled to undergo surgery for medical reasons or will donate a single or a few hairs--to be removed intact from the scull or other areas in the body.
- Healthy donors scheduled to undergo surgery for medical reasons or will donate a single or a few hairs--to be removed intact from the scull or other areas in the body.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Ein Kerem
Jerusalem, Israel, 9112100
Benjamin E Reubinoff, Professor, 972-2-6776424/5, benr@hadassah.org.il
Shelly E Tannenbaum, MSQA, 972-2-6775700, stannenbaum@hadassah.org.il
About this study
Official title: Derivation of Induced Pluripotent Stem Cells from Somatic Cells Donated by Patients with Neurological Diseases for the Study of the Pathogenesis of the Disorders and Development of Novel Therapies
Human fibroblasts and possibly other human somatic cells may be reprogrammed into induced pluripotent stem (iPS) cells by the forced expression of transcription factors (1-5). The iPS cells seem to share many properties with human embryonic stem cells.
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 cell cultures from skin biopsies or the patient's hair. The iPS cells will be developed primarily for modeling diseases and drug discovery as well as basic research, and for developing the technology that may eventually allow the use of iPS cells for future transplantation therapy. The iPS cells developed in the course of this application are not intended for use in transplantation therapy. Future development of iPS cells for clinical transplantation therapies will be subjected to the appropriate authorization by ethical and regulatory committees.
Read the detailed description
The derivation of human iPS cells (1-5) open new avenues to model human diseases since it may now be possible to develop iPS cells from the fibroblasts or other somatic cells of patients with various conditions. These iPS cells may be directed to differentiate into the cells which are affected in specific conditions. Abnormalities in the development of the affected cells as well as altered survival or function of the cells may be studied. Thus iPS cells may serve as an invaluable model for the study of the pathogenesis of human diseases and may also serve for the development of new drugs, and high throughput screening of molecules for toxic or therapeutic effects.
In addition to the great potential of iPS cells for disease modelling and transplantation therapy, the cells may have broad applications in basic research in various areas such as reprogramming, basic development and others.
At present, it is still unclear whether the properties of iPS cells are identical to those of hESCs. Initial data suggest that human iPS cells are indeed similar to hESCs in their phenotype, epigenetic status of pluripotent self-specific genes, telomerase activity, gene expression profile and in their capability to differentiate into progeny of the three germ layers both in vitro and in vivo in teratomas (2, 3, 5). In the mouse system, directed differentiation of iPS cells into bone marrow repopulating hematopoietic stem cells and functional dopaminergic neurons was demonstrated (6, 7). However, incomplete silencing of the constitutive expression of the transcription factors that were used to induce reprogramming can probably interfere with differentiation (1). Further studies are required to confirm that the developmental potential and biological properties of iPS cells are identical to hESC.
Currently, retroviral vectors are most commonly used to introduce and express the transgenes which reprogram the somatic nucleus (1-5). The use of retroviral vectors, which integrate into the host cell genome, may cause hazardous insertion mutagenesis. Moreover, the use of potentially oncogenic transcription factors, such as c-Myc, significantly limits the clinical use of human iPS cells for future cell therapy. However, successful derivation of iPS cells was demonstrated without the forced expression of c-Myc. The decreased efficiency of reprogramming, in the absence of overexpressed c-Myc, may be improved by molecules which act via epigenetic mechanisms. Moreover, successful derivation of iPS cells was recently reported with the use of non-integrating adeno viral vectors or repeated transfections. Thus it appears that with further developments, it may be possible in the future to safely induce pluripotent cells from somatic cells for therapeutic applications.
- Conditions
- Neurodegenerative Disorders
- Keywords
- Amyotrophic Lateral Sclerosis, Familial Dysautonomia, Parkinson's Disease, Alzheimer's Disease, Age Related Macular Degeneration, Retinitis Pigmentosa, Huntington's Disease, Machado - Joseph Disease, SMA - Spinal Muscular Atrophy, Ataxia Telangiectasia
- Medical subject headings
- Neurodegenerative Diseases, Amyotrophic Lateral Sclerosis, Dysautonomia, Familial, Parkinson Disease, Alzheimer Disease, Macular Degeneration, Retinitis Pigmentosa, Huntington Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study startApr 2009
- 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 Neurodegenerative DisordersStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin E Reubinoff, MD, PhD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00874783
- Sponsor's protocol ID
- 0599-08-HMO-CTIL
- Status last verified
- Mar 2025
- First submitted
- 2 Apr 2009
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Yu J, Vodyanik MA, Smuga-Otto K, Antosiewicz-Bourget J, Frane JL, Tian S, Nie J, Jonsdottir GA, Ruotti V, Stewart R, Slukvin II, Thomson JA. Induced pluripotent stem cell lines derived from human somatic cells. Science. 2007 Dec 21;318(5858):1917-20. doi: 10.1126/science.1151526. Epub 2007 Nov 20.
PubMed 18029452
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Derivation of Induced Pluripotent Stem Cells from Somatic Cells Donated by Patients with Neurological Diseases for the Study of the Pathogenesis of the Disorders and Development of Novel Therapies
- ClinicalTrials.gov ID
- NCT00874783
- Acronym / sponsor ID
- 0599-08-HMO-CTIL
- Conditions
- Neurodegenerative Disorders
- Keywords
- Amyotrophic Lateral Sclerosis, Familial Dysautonomia, Parkinson's Disease, Alzheimer's Disease, Age Related Macular Degeneration, Retinitis Pigmentosa, Huntington's Disease, Machado - Joseph Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Apr 2009 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 3 Apr 2009 (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.
Human fibroblasts and possibly other human somatic cells may be reprogrammed into induced pluripotent stem (iPS) cells by the forced expression of transcription factors (1-5). The iPS cells seem to share many properties with human embryonic stem cells.
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 cell cultures from skin biopsies or the patient's hair. The iPS cells will be developed primarily for modeling diseases and drug discovery as well as basic research, and for developing the technology that may eventually allow the use of iPS cells for future transplantation therapy. The iPS cells developed in the course of this application are not intended for use in transplantation therapy. Future development of iPS cells for clinical transplantation therapies will be subjected to the appropriate authorization by ethical and regulatory committees.
Detailed description
The derivation of human iPS cells (1-5) open new avenues to model human diseases since it may now be possible to develop iPS cells from the fibroblasts or other somatic cells of patients with various conditions. These iPS cells may be directed to differentiate into the cells which are affected in specific conditions. Abnormalities in the development of the affected cells as well as altered survival or function of the cells may be studied. Thus iPS cells may serve as an invaluable model for the study of the pathogenesis of human diseases and may also serve for the development of new drugs, and high throughput screening of molecules for toxic or therapeutic effects.
In addition to the great potential of iPS cells for disease modelling and transplantation therapy, the cells may have broad applications in basic research in various areas such as reprogramming, basic development and others.
At present, it is still unclear whether the properties of iPS cells are identical to those of hESCs. Initial data suggest that human iPS cells are indeed similar to hESCs in their phenotype, epigenetic status of pluripotent self-specific genes, telomerase activity, gene expression profile and in their capability to differentiate into progeny of the three germ layers both in vitro and in vivo in teratomas (2, 3, 5). In the mouse system, directed differentiation of iPS cells into bone marrow repopulating hematopoietic stem cells and functional dopaminergic neurons was demonstrated (6, 7). However, incomplete silencing of the constitutive expression of the transcription factors that were used to induce reprogramming can probably interfere with differentiation (1). Further studies are required to confirm that the developmental potential and biological properties of iPS cells are identical to hESC.
Currently, retroviral vectors are most commonly used to introduce and express the transgenes which reprogram the somatic nucleus (1-5). The use of retroviral vectors, which integrate into the host cell genome, may cause hazardous insertion mutagenesis. Moreover, the use of potentially oncogenic transcription factors, such as c-Myc, significantly limits the clinical use of human iPS cells for future cell therapy. However, successful derivation of iPS cells was demonstrated without the forced expression of c-Myc. The decreased efficiency of reprogramming, in the absence of overexpressed c-Myc, may be improved by molecules which act via epigenetic mechanisms. Moreover, successful derivation of iPS cells was recently reported with the use of non-integrating adeno viral vectors or repeated transfections. Thus it appears that with further developments, it may be possible in the future to safely induce pluripotent cells from somatic cells for therapeutic applications.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 120 donors to cover 10 different neurodegenerative disorders (previously specified) based on 10 donors per disorder and 20 healthy control donors.
Key inclusion criteria (2 listed)
- Donors suffering from different (specified) neurodegenerative disorders scheduled to undergo surgery for medical reasons or will donate a single or a few hairs--to be removed intact from the scull or other areas in the body.
- Healthy donors scheduled to undergo surgery for medical reasons or will donate a single or a few hairs--to be removed intact from the scull or other areas in the body.
Key exclusion criteria (1 listed)
- None
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 4 Mar 2025.
- Background: PubMed 18029452Yu J, Vodyanik MA, Smuga-Otto K, Antosiewicz-Bourget J, Frane JL, Tian S, Nie J, Jonsdottir GA, Ruotti V, Stewart R, Slukvin II, Thomson JA. Induced pluripotent stem cell lines derived from human somatic cells. Science. 2007 Dec 21;318(5858):1917-20. doi: 10.1126/science.1151526. Epub 2007 Nov 20.
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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
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurodegenerative Disorders, run by Hadassah Medical Organization at 1 site 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 4 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 1 site 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, MD 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 NCT00874783, 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 4 Mar 2025.