Side Effects of Bone Marrow Derived CD133 Transplantation in Cerebral Palsy
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| ClinicalTrials.gov Identifier: NCT01404663 |
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Recruitment Status :
Completed
First Posted : July 28, 2011
Last Update Posted : March 7, 2018
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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 bone marrow stem cell transplantation in patients with cerebral palsy.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cerebral Palsy | Biological: CD133 stem cell injection | Phase 1 |
Our study evaluate the side effects of bone marrow derived CD133 cells transplantation in 4-12years old patients with cerebral palsy.first all the patients undergone a comprehensive evaluation(physical exam, serology tests,EEG,MRI,GMFM66).
After bone marrow aspiration,autologous stem cells prepare for each patient. In operation room ,the cells are transplanted by intrathecal injection. all the patients would be under observed to notice acute side effects and 3,6,9 and 12 months after injection they will be followed and evaluate by comprehensive tests.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 12 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Evaluation the Side Effects of Bone Marrow Derived CD133 Cells Transplantation in Cerebral Palsy Patients |
| Study Start Date : | October 2011 |
| Actual Primary Completion Date : | April 2012 |
| Actual Study Completion Date : | May 2012 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: stem cell recipients
The 4-12 years old patients with cerebral palsy who undergone bone marrow derived CD133 transplantation
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Biological: CD133 stem cell injection
Bone marrow derived CD133 stem cell witch are transplanted by intrathecal injection
Other Name: stem cell transplantation |
- allergic reaction [ Time Frame: 1 month ]evaluation the side effects of bone marrow derived CD133 transplantation in cerebral palsy patients
- local infection [ Time Frame: 1 month ]infections in site of injection
- encephalitis [ Time Frame: 1 month ]encephalitis due to cell transplantation
- meningitis [ Time Frame: 1 month ]meningitis due to cell trnsplantation
- paralysis or sensory loss [ Time Frame: 6 months ]paralysis or sensory loss below the level of the injection site
- speech [ Time Frame: 6 months ]evaluation the effect of bone marrow derived CD133 cells transplantation to improve speech ability in patients with cerebral palsy
- motion [ Time Frame: 6 months ]evaluation the effect of bone marrow derived CD133 transplantation to improve motion disability in patients with cerebral palsy
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| Ages Eligible for Study: | 4 Years to 12 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- A 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
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01404663
| Iran, Islamic Republic of | |
| Royan Institute | |
| Tehran, Iran, Islamic Republic of | |
| Study Chair: | Hamid Gourabi, PhD | Head of Royan Institute | |
| Study Director: | Nasser Aghdami, MD,PhD | Head of Cell therapy Center | |
| Principal Investigator: | AliReza Zaali, MD | Head of Research center of neurosurgery | |
| Principal Investigator: | Leila Arab, MD | Department of regenerative medicine,Royan Institute |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Royan Institute |
| ClinicalTrials.gov Identifier: | NCT01404663 History of Changes |
| Other Study ID Numbers: |
Royan-nerve-002 |
| First Posted: | July 28, 2011 Key Record Dates |
| Last Update Posted: | March 7, 2018 |
| Last Verified: | August 2010 |
Keywords provided by Royan Institute:
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bone marrow CD133 transplantation side effects side effects |
Additional relevant MeSH terms:
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Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases |