Efficacy of Allogeneic Umbilical Cord Derived Hematopoietic and Mesenchymal Stem Cells in Cerebral Palsy

NCT03795974 | Unknown Phase 2 DMC

• 1 other identifier: IRCT201706176907N13
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 4

Brief Summary

Cerebral palsy(CP) consisted of a group of developmental disability in the field of motor function and is one of the major problems of pediatric neurology and at the present time there is no standard curative medical or surgical treatment for it .Stem cell therapy is one of a new and hopeful therapeutic methods of therapy for CP .This double blind study designed for the evaluation of safety and therapeutic effects of intrathecal hematopoietic and mesenchymal stem cells derived from allogenic umbilical cord in change and probable improvement of developmental functions of spastic CP participants between 4-14 years old and comparing with control group of CP participants without cell therapy . 108 cases recruited and randomly divided to 3 groups of 36 cases : hematopoietic stem cells derived from allogenic umbilical cord , Mesenchymal cells derived from allogenic umbilical cord and control group without injection and appearance simulating lumbar puncture without awareness of the patients and evaluators . Developmental functions and spasticity evaluated before intervention and will be done 1 , 3 , 6 and 12 months after injection . During this period neuro rehabilitation will be continued . Brain neuroimaging were done at the recruitment time and will be repeated after 12 months .

Conditions

Cerebral Palsy, Spastic

Keywords

Quadriparetic CP, Diparetic CP, Spastic

Outcome Measures

Primary Outcomes (21)

• Change from baseline Gross Motor Function Classification System (GMFCS)

  The Gross Motor Function Classification System (GMFCS) for cerebral palsy is based on self-initiated movement, with emphasis on sitting, transfers, and mobility. When defining a five-level classification system, our primary criterion has been that the distinctions between levels must be meaningful in daily life. Distinctions are based on functional limitations, the need for hand-held mobility devices (such as walkers, crutches, or canes) or wheeled mobility, and to a much lesser extent, quality of movement. LEVEL I - Walks without Limitations LEVEL II - Walks with Limitations LEVEL III - Walks Using a Hand-Held Mobility Device LEVEL IV - Self-Mobility with Limitations; May Use Powered Mobility LEVEL V - Transported in a Manual Wheelchair We enrolled the patients with GMFCS more than class II and evaluate for change of this scale during the follow up period . Lower scores demonstrate better gross motor function of children .

  Baseline

• Change from baseline Gross Motor Function Classification System (GMFCS)

  The Gross Motor Function Classification System (GMFCS) for cerebral palsy is based on self-initiated movement, with emphasis on sitting, transfers, and mobility. When defining a five-level classification system, our primary criterion has been that the distinctions between levels must be meaningful in daily life. Distinctions are based on functional limitations, the need for hand-held mobility devices (such as walkers, crutches, or canes) or wheeled mobility, and to a much lesser extent, quality of movement. LEVEL I - Walks without Limitations LEVEL II - Walks with Limitations LEVEL III - Walks Using a Hand-Held Mobility Device LEVEL IV - Self-Mobility with Limitations; May Use Powered Mobility LEVEL V - Transported in a Manual Wheelchair We enrolled the patients with GMFCS more than class II and evaluate for change of this scale during the follow up period . Lower scores demonstrate better gross motor function of children .

  "month" 3

• Change from baseline Gross Motor Function Classification System (GMFCS)

  The Gross Motor Function Classification System (GMFCS) for cerebral palsy is based on self-initiated movement, with emphasis on sitting, transfers, and mobility. When defining a five-level classification system, our primary criterion has been that the distinctions between levels must be meaningful in daily life. Distinctions are based on functional limitations, the need for hand-held mobility devices (such as walkers, crutches, or canes) or wheeled mobility, and to a much lesser extent, quality of movement. LEVEL I - Walks without Limitations LEVEL II - Walks with Limitations LEVEL III - Walks Using a Hand-Held Mobility Device LEVEL IV - Self-Mobility with Limitations; May Use Powered Mobility LEVEL V - Transported in a Manual Wheelchair We enrolled the patients with GMFCS more than class II and evaluate for change of this scale during the follow up period . Lower scores demonstrate better gross motor function of children .

  "month" 6

• Change from baseline Gross Motor Function Classification System (GMFCS)

  The Gross Motor Function Classification System (GMFCS) for cerebral palsy is based on self-initiated movement, with emphasis on sitting, transfers, and mobility. When defining a five-level classification system, our primary criterion has been that the distinctions between levels must be meaningful in daily life. Distinctions are based on functional limitations, the need for hand-held mobility devices (such as walkers, crutches, or canes) or wheeled mobility, and to a much lesser extent, quality of movement. LEVEL I - Walks without Limitations LEVEL II - Walks with Limitations LEVEL III - Walks Using a Hand-Held Mobility Device LEVEL IV - Self-Mobility with Limitations; May Use Powered Mobility LEVEL V - Transported in a Manual Wheelchair We enrolled the patients with GMFCS more than class II and evaluate for change of this scale during the follow up period . Lower scores demonstrate better gross motor function of children .

  "month" 12

• Change from baseline GROSS MOTOR FUNCTION MEASURE (GMFM66)

  The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. GMFM 66 contained 66 item and each item include 4 score (0-3) SCORING KEY 0 = does not initiate 1 = initiates 2 = partially completes 3 = completes We are using validated Persian version of GMFM 66 in this research. Higher scores demonstrate better gross motor function of children.

  Baseline

• Change from baseline GROSS MOTOR FUNCTION MEASURE (GMFM66)

  The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. GMFM 66 contained 66 item and each item include 4 score (0-3) SCORING KEY 0 = does not initiate 1 = initiates 2 = partially completes 3 = completes We are using validated Persian version of GMFM 66 in this research. Higher scores demonstrate better gross motor function of children.

  "month" 1

• Change from baseline GROSS MOTOR FUNCTION MEASURE (GMFM66)

  The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. GMFM 66 contained 66 item and each item include 4 score (0-3) SCORING KEY 0 = does not initiate 1 = initiates 2 = partially completes 3 = completes We are using validated Persian version of GMFM 66 in this research. Higher scores demonstrate better gross motor function of children.

  "month" 3

• Change from baseline GROSS MOTOR FUNCTION MEASURE (GMFM66)

  The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. GMFM 66 contained 66 item and each item include 4 score (0-3) SCORING KEY 0 = does not initiate 1 = initiates 2 = partially completes 3 = completes We are using validated Persian version of GMFM 66 in this research. Higher scores demonstrate better gross motor function of children.

  "month" 6

• Change from baseline GROSS MOTOR FUNCTION MEASURE (GMFM66)

  The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. GMFM 66 contained 66 item and each item include 4 score (0-3) SCORING KEY 0 = does not initiate 1 = initiates 2 = partially completes 3 = completes We are using validated Persian version of GMFM 66 in this research. Higher scores demonstrate better gross motor function of children.

  "month" 12

• Change from baseline Manual Ability Classification System for Children with Cerebral Palsy (MACS)

  The Manual Ability Classification System (MACS)describes how children with cerebral palsy (CP)use their hands to handle objects in daily activities. MACS describes five levels. The levels are based on the children's self-initiated ability to handle objects and their need for assistance or adaptation to perform manual activities in everyday life. 1. Handle objects easily and successfully 2. Handles most objects but with somewhat reduced quality and/or speed of achievement 3. Handle objects with difficulty; needs help to prepare and/or modify activities 4. Handles a limited selection of easily managed objects in adapted situations 5. Does not handle objects and has severely limited ability to perform even simple actions Level I include children with minor limitations, while children with severe functional limitations will usually be found at levels IV and V. We are using validated Persian classification system.

  Baseline

• Change from baseline Manual Ability Classification System for Children with Cerebral Palsy (MACS)

  The Manual Ability Classification System (MACS)describes how children with cerebral palsy (CP)use their hands to handle objects in daily activities. MACS describes five levels. The levels are based on the children's self-initiated ability to handle objects and their need for assistance or adaptation to perform manual activities in everyday life. 1. Handle objects easily and successfully 2. Handles most objects but with somewhat reduced quality and/or speed of achievement 3. Handle objects with difficulty; needs help to prepare and/or modify activities 4. Handles a limited selection of easily managed objects in adapted situations 5. Does not handle objects and has severely limited ability to perform even simple actions Level I include children with minor limitations, while children with severe functional limitations will usually be found at levels IV and V. We are using validated Persian classification system.

  "month" 3

• Change from baseline Manual Ability Classification System for Children with Cerebral Palsy (MACS)

  The Manual Ability Classification System (MACS)describes how children with cerebral palsy (CP)use their hands to handle objects in daily activities. MACS describes five levels. The levels are based on the children's self-initiated ability to handle objects and their need for assistance or adaptation to perform manual activities in everyday life. 1. Handle objects easily and successfully 2. Handles most objects but with somewhat reduced quality and/or speed of achievement 3. Handle objects with difficulty; needs help to prepare and/or modify activities 4. Handles a limited selection of easily managed objects in adapted situations 5. Does not handle objects and has severely limited ability to perform even simple actions Level I include children with minor limitations, while children with severe functional limitations will usually be found at levels IV and V. We are using validated Persian classification system.

  "month" 6

• Change from baseline Manual Ability Classification System for Children with Cerebral Palsy (MACS)

  The Manual Ability Classification System (MACS)describes how children with cerebral palsy (CP)use their hands to handle objects in daily activities. MACS describes five levels. The levels are based on the children's self-initiated ability to handle objects and their need for assistance or adaptation to perform manual activities in everyday life. 1. Handle objects easily and successfully 2. Handles most objects but with somewhat reduced quality and/or speed of achievement 3. Handle objects with difficulty; needs help to prepare and/or modify activities 4. Handles a limited selection of easily managed objects in adapted situations 5. Does not handle objects and has severely limited ability to perform even simple actions Level I include children with minor limitations, while children with severe functional limitations will usually be found at levels IV and V. We are using validated Persian classification system.

  "month" 12

• Change from baseline Pediatric Evaluation of Disability Inventory (PEDI)

  The PEDI contains items to measure functional capability, and also items to measure the performance in three content domains: Self Care (SC), Mobility (M) and Social Function (SF), Capability is measured by the assessment of the functional skills of which the child has shown mastery. The items in the FSS are discrete and are accompanied by scoring criteria and sometimes examples of behavior to help clarify scoring decisions. The items can be scored 0 or 1. 0 = unable or limited in capability to perform item in most situations 1 = capable of performing item in most situations, or item has been previously mastered and functional skills have progressed beyond this level. We are using validated Persian version of this Questionnaire. Higher scores demonstrate better functional capability.

  Baseline

• Change from baseline Pediatric Evaluation of Disability Inventory (PEDI)

  The PEDI contains items to measure functional capability, and also items to measure the performance in three content domains: Self Care (SC), Mobility (M) and Social Function (SF), Capability is measured by the assessment of the functional skills of which the child has shown mastery. The items in the FSS are discrete and are accompanied by scoring criteria and sometimes examples of behavior to help clarify scoring decisions. The items can be scored 0 or 1. 0 = unable or limited in capability to perform item in most situations 1 = capable of performing item in most situations, or item has been previously mastered and functional skills have progressed beyond this level. We are using validated Persian version of this Questionnaire. Higher scores demonstrate better functional capability.

  "month" 6

• Change from baseline Pediatric Evaluation of Disability Inventory (PEDI)

  The PEDI contains items to measure functional capability, and also items to measure the performance in three content domains: Self Care (SC), Mobility (M) and Social Function (SF), Capability is measured by the assessment of the functional skills of which the child has shown mastery. The items in the FSS are discrete and are accompanied by scoring criteria and sometimes examples of behavior to help clarify scoring decisions. The items can be scored 0 or 1. 0 = unable or limited in capability to perform item in most situations 1 = capable of performing item in most situations, or item has been previously mastered and functional skills have progressed beyond this level. We are using validated Persian version of this Questionnaire. Higher scores demonstrate better functional capability.

  "month" 12

• Change from baseline Modified Ashworth scale

  Scoring (taken from Bohannon and Smith, 1987): 0 No increase in muscle tone 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension ankle plantar flexion ,knee flexion ,hip flexion , wrist flexion , elbow flexion will be exam-ed by Modified Ashwotth scale and change in severity of spasticity ankle plantar flexion,knee flexion,hip flexion,wrist flexion,elbow flexion,Spasticity improvement of patients according to Modified Ashworth scale

  Baseline

• Change from baseline Modified Ashworth scale

  Scoring (taken from Bohannon and Smith, 1987): 0 No increase in muscle tone 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension ankle plantar flexion ,knee flexion ,hip flexion , wrist flexion , elbow flexion will be exam-ed by Modified Ashwotth scale and change in severity of spasticity ankle plantar flexion,knee flexion,hip flexion,wrist flexion,elbow flexion,Spasticity improvement of patients according to Modified Ashworth scale

  "month" 1

• Change from baseline Modified Ashworth scale

  Scoring (taken from Bohannon and Smith, 1987): 0 No increase in muscle tone 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension ankle plantar flexion ,knee flexion ,hip flexion , wrist flexion , elbow flexion will be exam-ed by Modified Ashwotth scale and change in severity of spasticity ankle plantar flexion,knee flexion,hip flexion,wrist flexion,elbow flexion,Spasticity improvement of patients according to Modified Ashworth scale

  "month" 3

• Change from baseline Modified Ashworth scale

  Scoring (taken from Bohannon and Smith, 1987): 0 No increase in muscle tone 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension ankle plantar flexion ,knee flexion ,hip flexion , wrist flexion , elbow flexion will be exam-ed by Modified Ashwotth scale and change in severity of spasticity ankle plantar flexion,knee flexion,hip flexion,wrist flexion,elbow flexion,Spasticity improvement of patients according to Modified Ashworth scale

  "month" 6

• Change from baseline Modified Ashworth scale

  Scoring (taken from Bohannon and Smith, 1987): 0 No increase in muscle tone 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension ankle plantar flexion ,knee flexion ,hip flexion , wrist flexion , elbow flexion will be exam-ed by Modified Ashwotth scale and change in severity of spasticity ankle plantar flexion,knee flexion,hip flexion,wrist flexion,elbow flexion,Spasticity improvement of patients according to Modified Ashworth scale

  "month" 12

Secondary Outcomes (6)

• Change from baseline acquired Brain Magnetic Resonance Imaging (MRI) findings

  Baseline

• Change from baseline acquired Brain Magnetic Resonance Imaging (MRI) findings

  "month" 12

• Change from baseline Brain Magnetic Resonance Spectroscopy (MRS)

  Baseline

• Change from baseline Brain Magnetic Resonance Spectroscopy (MRS)

  "month" 12

• Change from baseline Diffuse Tensor Imaging (DTI) fiber count of periventricular white matter

  Baseline

Study Arms (2)

MNC & MSC with Control

ACTIVE COMPARATOR

One intrathecal injection of Hematopoietic stem cells and Mesenchymal stem cells derived from allogenic umbilical cord for each group of 36 cases of spastic CP and neurorehabilitation during the 12 months of follow up of clinical evaluation of developmental functions and spasticity

Biological: MNC; Biological: MSC; Procedure: Control

MNC & MSC

EXPERIMENTAL

Comparison of effects of intrathecal injection of MNC and MSC on improvement of developmental functions and spasticity of CP patients

Biological: MNC; Biological: MSC

Interventions

MNC BIOLOGICAL

Hematopoietic stem cells derived from allogenic umbilical cord

Also known as: Hematopoietic stem cells

MNC & MSC; MNC & MSC with Control

MSC BIOLOGICAL

Mesenchymal cells derived from allogenic umbilical cord

Also known as: Mesenchymal stem cells

MNC & MSC; MNC & MSC with Control

Control PROCEDURE

control group without injection and appearance simulating lumbar puncture without awareness of the patients and evaluators , but rehabilitation continued .

MNC & MSC with Control

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Spastic cerebral palsy (Diparetic , Quadriparetic)
• Ages between 4 - 14 years
• Gross motor function classification ( GMFC) between 2 -5
• No seizure disorder or with controlled seizures
• Evidence of definite acquired abnormal imaging findings compatible with CP
• Informed consent is taken from their parents

You may not qualify if:

• Normal brain MRI
• Progressive neurologic disorders
• Congenital cortical malformations
• TORCH infections (Toxoplasmosis,Other,Rubella,Cytomegalovirus and Herpes infections)
• Other types of cerebral palsy including athetoid , atonic , ataxic , and mixed type
• Acute intercurrent infections such as Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), Human Immunodeficiency Virus (HIV) Malignancies
• Hemorrhagic diathesis
• Severe anemia ( Hemoglobin less than 8 g/dl )
• Ventilator dependent pulmonary diseases
• Renal insufficiency
• Severe liver dysfunction

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead
• Hormozgan University of Medical Sciences: collaborator

Study Sites (4)

Tehran University of Medical Sciences , Growth and Development Research Center- Children's Medical Center

Tehran, 1419733151, Iran

Location

Tehran University of Medical Sciences Chidren's Medical Center Radiology Department

Tehran, 1419733151, Iran

Location

Tehran University of Medical Sciences, Department of Pediatric Neurology , Children's Medical Center

Tehran, 1419733151, Iran

Location

ROYAN Stem Cell Technology Co

Tehran, 1665666311, Iran

Location

Related Publications (12)

• Papadopoulos KI, Low SS, Aw TC, Chantarojanasiri T. Safety and feasibility of autologous umbilical cord blood transfusion in 2 toddlers with cerebral palsy and the role of low dose granulocyte-colony stimulating factor injections. Restor Neurol Neurosci. 2011;29(1):17-22. doi: 10.3233/RNN-2011-0572.

  PMID: 21335665 BACKGROUND

• Feng M, Lu A, Gao H, Qian C, Zhang J, Lin T, Zhao Y. Safety of Allogeneic Umbilical Cord Blood Stem Cells Therapy in Patients with Severe Cerebral Palsy: A Retrospective Study. Stem Cells Int. 2015;2015:325652. doi: 10.1155/2015/325652. Epub 2015 Jul 8.

  PMID: 26236347 BACKGROUND

• Thomas B, Eyssen M, Peeters R, Molenaers G, Van Hecke P, De Cock P, Sunaert S. Quantitative diffusion tensor imaging in cerebral palsy due to periventricular white matter injury. Brain. 2005 Nov;128(Pt 11):2562-77. doi: 10.1093/brain/awh600. Epub 2005 Jul 27.

  PMID: 16049045 BACKGROUND

• Zali A, Arab L, Ashrafi F, Mardpour S, Niknejhadi M, Hedayati-Asl AA, Halimi-Asl A, Ommi D, Hosseini SE, Baharvand H, Aghdami N. Intrathecal injection of CD133-positive enriched bone marrow progenitor cells in children with cerebral palsy: feasibility and safety. Cytotherapy. 2015 Feb;17(2):232-41. doi: 10.1016/j.jcyt.2014.10.011. Epub 2014 Nov 1.

  PMID: 25593079 RESULT

• Bax M, Goldstein M, Rosenbaum P, Leviton A, Paneth N, Dan B, Jacobsson B, Damiano D; Executive Committee for the Definition of Cerebral Palsy. Proposed definition and classification of cerebral palsy, April 2005. Dev Med Child Neurol. 2005 Aug;47(8):571-6. doi: 10.1017/s001216220500112x.

  PMID: 16108461 RESULT

• Shevell MI, Dagenais L, Hall N; REPACQ CONSORTIUM*. The relationship of cerebral palsy subtype and functional motor impairment: a population-based study. Dev Med Child Neurol. 2009 Nov;51(11):872-7. doi: 10.1111/j.1469-8749.2009.03269.x. Epub 2009 Mar 11.

  PMID: 19416339 RESULT

• Ashwal S, Russman BS, Blasco PA, Miller G, Sandler A, Shevell M, Stevenson R; Quality Standards Subcommittee of the American Academy of Neurology; Practice Committee of the Child Neurology Society. Practice parameter: diagnostic assessment of the child with cerebral palsy [RETIRED]: report of the Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society. Neurology. 2004 Mar 23;62(6):851-63. doi: 10.1212/01.wnl.0000117981.35364.1b.

  PMID: 15037681 RESULT

• Wang X, Cheng H, Hua R, Yang J, Dai G, Zhang Z, Wang R, Qin C, An Y. Effects of bone marrow mesenchymal stromal cells on gross motor function measure scores of children with cerebral palsy: a preliminary clinical study. Cytotherapy. 2013 Dec;15(12):1549-62. doi: 10.1016/j.jcyt.2013.06.001. Epub 2013 Oct 5.

  PMID: 24100132 RESULT

• Romanov YA, Svintsitskaya VA, Smirnov VN. Searching for alternative sources of postnatal human mesenchymal stem cells: candidate MSC-like cells from umbilical cord. Stem Cells. 2003;21(1):105-10. doi: 10.1634/stemcells.21-1-105.

  PMID: 12529557 RESULT

• Crompton KE, Elwood N, Kirkland M, Clark P, Novak I, Reddihough D. Feasibility of trialling cord blood stem cell treatments for cerebral palsy in Australia. J Paediatr Child Health. 2014 Jul;50(7):540-4. doi: 10.1111/jpc.12618. Epub 2014 Jun 9.

  PMID: 24909743 RESULT

• Zarrabi M, Akbari MG, Amanat M, Majmaa A, Moaiedi AR, Montazerlotfelahi H, Nouri M, Hamidieh AA, Badv RS, Karimi H, Rabbani A, Mohebbi A, Rahimi-Dehgolan S, Rahimi R, Dehghan E, Vosough M, Abroun S, Shamsabadi FM, Tavasoli AR, Alizadeh H, Pak N, Zamani GR, Mohammadi M, Javadzadeh M, Ghofrani M, Hassanpour SH, Heidari M, Taghdiri MM, Mohseni MJ, Noparast Z, Masoomi S, Goudarzi M, Mohamadpour M, Shodjaee R, Samimi S, Mohammad M, Gholami M, Vafaei N, Koochakzadeh L, Valizadeh A, Malamiri RA, Ashrafi MR. The safety and efficacy of umbilical cord blood mononuclear cells in individuals with spastic cerebral palsy: a randomized double-blind sham-controlled clinical trial. BMC Neurol. 2022 Mar 29;22(1):123. doi: 10.1186/s12883-022-02636-y.

  PMID: 35351020 DERIVED

• Amanat M, Majmaa A, Zarrabi M, Nouri M, Akbari MG, Moaiedi AR, Ghaemi O, Zamani F, Najafi S, Badv RS, Vosough M, Hamidieh AA, Salehi M, Montazerlotfelahi H, Tavasoli AR, Heidari M, Mohebi H, Fatemi A, Garakani A, Ashrafi MR. Clinical and imaging outcomes after intrathecal injection of umbilical cord tissue mesenchymal stem cells in cerebral palsy: a randomized double-blind sham-controlled clinical trial. Stem Cell Res Ther. 2021 Aug 6;12(1):439. doi: 10.1186/s13287-021-02513-4.

  PMID: 34362453 DERIVED

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mahmoudreza Ashrafi, MD

  Tehran University of Medical Sciences, Children's Medical Center

  PRINCIPAL INVESTIGATOR

• Amirali Hamidieh, MD

  Tehran University of Medical Sciences , Children's Medical Center

  STUDY DIRECTOR

• Hadi Montazerlotfelahi, MD

  Alborz University of Medical Sciences

  STUDY DIRECTOR

• Anahita Majma, MD

  Tehran University of Medical Sciences Children's Medical Center

  STUDY DIRECTOR

• Masood Ghahvechi akbari, MD

  Tehran University of Medical Sciences ,Children's Medical Center

  STUDY DIRECTOR

• Ali Reza Moaeidi, MD

  Hormozgan University of Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: only one of the investigators knows the type of cell therapy for intervention group and simulation of intrathecal injection for control group .
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatric Neurology

Model Details: HLA typing were done for 150 cases of spastic CP with our inclusion criteria and 36 cases of class 6 matching of HLA selected for hematopoietic stem cells derived from allogenic umbilical cord and 72 cases were randomly divided to Mesenchymal cells derived from allogenic umbilical cord and control group .

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: January 8, 2019
• Study Start: July 23, 2017
• Primary Completion: October 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 8, 2019

Record last verified: 2019-01

Locations

IR (4)