Amyotrophic Lateral SclerosisPhase 2/3NCT01933321
Effect of Intrathecal Administration of Hematopoietic Stem Cells in Patients With Amyotrophic Lateral Sclerosis (ALS)
A Phase 2/3 study testing Intrathecal autologous stem cell in people with Amyotrophic Lateral Sclerosis, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
Trial summary
Autologous cell therapy in patients with ALS can stimulate neuroplasticity, modifying the neurodegenerative process and stops the clinical progression of disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Intrathecal autologous stem cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteMexico
- Study dates
- Sep 2012to Jun 2014
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with a confirmed diagnosis of ALS according to El Escorial criteria. Diagnosis-time less than four years.
- Over 18 years old. Forced vital capacity ≥ 40%.
- One year of evolution.
- Adequate nutritional state
Who cannot join
- Severe bulbar ALS involucre.
- Inadequate nutritional status.
- Spondylotic myelopathy, or abnormalities in imaging study.
- Having concomitant neurological or psychiatric disease.
- Systemic disease with poor-control.
- History of treatment with steroids or immunoglobulins in the last year.
Show all 12Show fewer
- Participate in the past three months in a Clinical Trial.
- History of malignancy or cancer today.
- Intracranial hypertension.
- Clinical suggestive data of infection in the site of lumbar puncture.
- Tracheostomy.
- Use of mechanical ventilation. Forced vital capacity less than 40%. HIV-seropositive or presence of antibodies against hepatitis B or C in the serological studies.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Servicio Hematología Hospital Universitario
Monterrey, Nuevo León, 64460
About this study
Autologous cell therapy in patients with ALS can stimulate neuroplasticity, modifying the neurodegenerative process and stops the clinical progression of disease.
Read the detailed description
There is no more extensive information
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Intrathecal autologous stem cell
- Keywords
- ALS, stem cells
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal autologous stem cellBiological
Mobilization and collection of stem cells for intravenous and intrathecal administration
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal autologous stem cells | Experimental | Intrathecal stem cells will be administered to patients that fulfill the inclusion criteria. Receives: Biological: Intrathecal autologous stem cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of autologous intrathecal administration of hematopoietic stem cells in patients with ALS.
Measured: up to 12 months
Secondary outcomes (1)
To evaluate the safety of intrathecal administration of hematopoietic stem cells in patients with ALS.
Measured: During the procedure and at 1st, 2nd, 3rd, 6th and 12 th month after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study startSep 2012
- Primary completionJan 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez
- Investigators
- David Gomez-Almaguer, MD, Principal investigator, Hospital Universitario "Dr. José Eleuterio González"Jose C Jaime-Pérez, MD PhD, Study director, Hospital Universitario "Dr. José Eleuterio González"Héctor R Martínez-Rodríguez, MD PhD, Study chair, Hospital Universitario "Dr. José Eleuterio González"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933321
- Sponsor's protocol ID
- ALS and stem cell therapy
- Status last verified
- Apr 2015
- First submitted
- 28 Sep 2012
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intrathecal Administration of Hematopoietic Stem Cells in Patients With Amyotrophic Lateral Sclerosis (ALS)
- ClinicalTrials.gov ID
- NCT01933321
- Acronym / sponsor ID
- ALS and stem cell therapy
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- ALS, stem cells
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 2 Sep 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.
Autologous cell therapy in patients with ALS can stimulate neuroplasticity, modifying the neurodegenerative process and stops the clinical progression of disease.
Detailed description
There is no more extensive information
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intrathecal autologous stem cells | Experimental | Biological: Intrathecal autologous stem cellIntrathecal stem cells will be administered to patients that fulfill the inclusion criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with a confirmed diagnosis of ALS according to El Escorial criteria. Diagnosis-time less than four years.
- Over 18 years old. Forced vital capacity ≥ 40%.
- One year of evolution.
- Adequate nutritional state
Key exclusion criteria (12 listed)
- Severe bulbar ALS involucre.
- Inadequate nutritional status.
- Spondylotic myelopathy, or abnormalities in imaging study.
- Having concomitant neurological or psychiatric disease.
- Systemic disease with poor-control.
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 |
|---|---|---|
| Intrathecal autologous stem cellMobilization and collection of stem cells for intravenous and intrathecal administration | Biological | Intrathecal autologous stem cells |
Primary outcome
Evaluation of autologous intrathecal administration of hematopoietic stem cells in patients with ALS.
Time frame: up to 12 months
1 secondary outcome
To evaluate the safety of intrathecal administration of hematopoietic stem cells in patients with ALS.
Time frame: During the procedure and at 1st, 2nd, 3rd, 6th and 12 th month after the procedure
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 3 Apr 2015.
Related trials for Amyotrophic Lateral Sclerosis
RecruitingPhase 1/2
Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS
Amyotrophic Lateral Sclerosis
Not yet recruiting
A Study on the Addition of Alsum30 for the Treatment of Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS), Bacillus Coagulans
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Not yet recruitingPhase 1
Safety, Tolerability, and Pharmacodynamic Exploration of Orelabrutinib in Patients With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
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.
David Gomez-Almaguer, MD principal investigator
Hospital Universitario "Dr. José Eleuterio González"
Jose C Jaime-Pérez, MD PhD study director
Hospital Universitario "Dr. José Eleuterio González"
Héctor R Martínez-Rodríguez, MD PhD study chair
Hospital Universitario "Dr. José Eleuterio González"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intrathecal autologous stem cell in people with Amyotrophic Lateral Sclerosis, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
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 4 inclusion and 12 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 3 Apr 2015. 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 Mexico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Evaluation of autologous intrathecal administration of hematopoietic stem cells in patients with ALS. (time frame: up to 12 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 3 Apr 2015.