Cerebral PalsyPhase 1/2NCT01763255
Multiple Transplantation of Bone Marrow Derived CD133 Cell in Cerebral Palsy
A Phase 1/2 study testing stem cell intrathecal injection in people with Cerebral Palsy, run by Royan Institute at 1 site in Iran.
Trial summary
Cerebral palsy (CP) is condition, sometimes thought of as a group of disorders that can involve brain and nervous system functions such as movement, learning, hearing, seeing, and thinking.Cerebral palsy is caused by injuries or abnormalities of the brain. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- stem cell intrathecal injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteIran
- Study dates
- Apr 2012to Apr 2014
- Phase
- Phase 1/2
- 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosis of spastic quadriplegic CP Children must be between the ages of 4 and 12 years Children must be cleared by an orthopedic surgeon for risk of hip subluxation or dislocation and cannot have significant scoliosis (curvature > 40 degrees) Children must be seizure-free or seizure controlled
Who cannot join
- Children who have a diagnosis of "mixed" types of CP (i.e. athetosis) or other movement disorders (i.e. ataxia) Children who have had a selective dorsal rhizotomy, are presently are receiving intrathecal Baclofen, or have changed their spasticity medications in the past 6 months.
- Children who have a metallic or electrical implants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Safety of Multiple Intrathecal Injection of Bone Marrow Derived CD133 Cells in Patients With Cerebral Palsy
Cerebral palsy (CP) is condition, sometimes thought of as a group of disorders that can involve brain and nervous system functions such as movement, learning, hearing, seeing, and thinking.Cerebral palsy is caused by injuries or abnormalities of the brain. Most of these problems occur as the baby grows in the womb, but they can happen at any time during the first 2 years of life, while the baby's brain is still developing.Bone marrow derived stem cells are known as a effective therapy.
In this study the investigators evaluate the side effect of multiple intrathecal injection of bone marrow stem cell in patients with cerebral palsy.
Read the detailed description
In this study,we evaluate the safety of multiple transplantation of bone marrow derived stem cells.the children(4-12years)with definite diagnose of cerebral palsy enroll to the study.first of all all the physical exam,laboratory test,EEG and MRI is done.after hospital admission,the patient underwent bone marrow transplantation.In laboratory,the cells are separated and prepared for injection.after 24hours the neurosurgeon inject the cells(intrathecal).the patient would be under observed for 48hours.If no allergic reaction or abnormal neurological symptoms accrued,patients can be discharged and would be followed up 1,3 and 6months after injection.at the end of the 6months,the patients would receive second injection as same as the previous process.then they are followed at 1,3 immediate local and systemic side effect(fever,respiratory distress,erythema,rash,increase of heart rate or blood pressure)and neurological symptoms:motor dysfunction,sensory dysfunction,sphincter dysfunction,nausea,vomiting,head ache.EEG,MRI,GMFM66
- Conditions
- Cerebral Palsy
- Being tested
- stem cell intrathecal injection
- Keywords
- cerebral palsy CD133 cells intrathecal injection
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stem cell intrathecal injectionBiological
Also called Stem cell transplantation
Intrathecal injection of Bone marrow derived CD133 cells
| Study group | Role | What they receive |
|---|---|---|
| CD133 transplantation | Experimental | The patients with cerebral palsy that underwent CD133 transplantation. Receives: Biological: stem cell intrathecal injection |
| Control | No intervention | The patients with cerebral palsy that underwent regular observation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
motor dysfunction
Evaluation the motor dysfunction 6months after intrathecal injection.
Measured: 6months
sensory dysfunction
Evaluation the sensory dysfunction after intrathecal injection of CD133 cells.
Measured: 6months
unconsciousness
Evaluation the rate of unconsciousness during 48hours after cell transplantation.
Measured: 48hours
fever
Evaluation the symptom of infection like fever 48hours after cell transplantation.
Measured: 48hours
Secondary outcomes (3)
motor improvement
Measure the improvement of motor system by GMFM66.
Measured: 6months
Balance improvement
Measure the balance improvement by BBS.
Measured: 6months
Spasm
Evaluation the improvement of spasm after stem cell transplantation.
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2013 (estimated)
- Study startApr 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hamid Gourabi, PhD, Study chair, Head of Royan InstituteNasser Aghdami, MD,PhD, Study director, Head of Royan department of degenerative medicine,Head of Royan celltherapy centerAli Reza Zali, MD, Study director, Head of Neurosurgery research center of Shahid Beheshti University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763255
- Sponsor's protocol ID
- Royan-Nerve-003
- Status last verified
- Jan 2011
- First submitted
- 25 Dec 2012
- Last updated
- 25 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety of Multiple Intrathecal Injection of Bone Marrow Derived CD133 Cells in Patients With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT01763255
- Acronym / sponsor ID
- Royan-Nerve-003
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy CD133 cells intrathecal injection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Study start
- Apr 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 8 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.
Cerebral palsy (CP) is condition, sometimes thought of as a group of disorders that can involve brain and nervous system functions such as movement, learning, hearing, seeing, and thinking.Cerebral palsy is caused by injuries or abnormalities of the brain. Most of these problems occur as the baby grows in the womb, but they can happen at any time during the first 2 years of life, while the baby's brain is still developing.Bone marrow derived stem cells are known as a effective therapy.
In this study the investigators evaluate the side effect of multiple intrathecal injection of bone marrow stem cell in patients with cerebral palsy.
Detailed description
In this study,we evaluate the safety of multiple transplantation of bone marrow derived stem cells.the children(4-12years)with definite diagnose of cerebral palsy enroll to the study.first of all all the physical exam,laboratory test,EEG and MRI is done.after hospital admission,the patient underwent bone marrow transplantation.In laboratory,the cells are separated and prepared for injection.after 24hours the neurosurgeon inject the cells(intrathecal).the patient would be under observed for 48hours.If no allergic reaction or abnormal neurological symptoms accrued,patients can be discharged and would be followed up 1,3 and 6months after injection.at the end of the 6months,the patients would receive second injection as same as the previous process.then they are followed at 1,3 immediate local and systemic side effect(fever,respiratory distress,erythema,rash,increase of heart rate or blood pressure)and neurological symptoms:motor dysfunction,sensory dysfunction,sphincter dysfunction,nausea,vomiting,head ache.EEG,MRI,GMFM66
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CD133 transplantation | Experimental | Biological: stem cell intrathecal injectionThe patients with cerebral palsy that underwent CD133 transplantation. |
| Control | No intervention | –The patients with cerebral palsy that underwent regular observation. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- diagnosis of spastic quadriplegic CP Children must be between the ages of 4 and 12 years Children must be cleared by an orthopedic surgeon for risk of hip subluxation or dislocation and cannot have significant scoliosis (curvature > 40 degrees) Children must be seizure-free or seizure controlled
Key exclusion criteria (2 listed)
- Children who have a diagnosis of "mixed" types of CP (i.e. athetosis) or other movement disorders (i.e. ataxia) Children who have had a selective dorsal rhizotomy, are presently are receiving intrathecal Baclofen, or have changed their spasticity medications in the past 6 months.
- Children who have a metallic or electrical implants
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 |
|---|---|---|
| stem cell intrathecal injectionAlso: Stem cell transplantationIntrathecal injection of Bone marrow derived CD133 cells | Biological | CD133 transplantation |
Primary outcome
motor dysfunction
Time frame: 6months
Evaluation the motor dysfunction 6months after intrathecal injection.
sensory dysfunction
Time frame: 6months
Evaluation the sensory dysfunction after intrathecal injection of CD133 cells.
unconsciousness
Time frame: 48hours
Evaluation the rate of unconsciousness during 48hours after cell transplantation.
fever
Time frame: 48hours
Evaluation the symptom of infection like fever 48hours after cell transplantation.
3 secondary outcomes
motor improvement
Time frame: 6months
Balance improvement
Time frame: 6months
Spasm
Time frame: 6months
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 25 Apr 2014.
- Related InfoLink 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.
Hamid Gourabi, PhD study chair
Head of Royan Institute
Nasser Aghdami, MD,PhD study director
Head of Royan department of degenerative medicine,Head of Royan celltherapy center
Ali Reza Zali, MD study director
Head of Neurosurgery research center of Shahid Beheshti 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 stem cell intrathecal injection in people with Cerebral Palsy, run by Royan Institute at 1 site in Iran.
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 1 inclusion and 2 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 25 Apr 2014. 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 Iran. 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?
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?
motor dysfunction (time frame: 6months). The study lists 4 primary outcomes in all. 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 25 Apr 2014.