NCT03078621

Brief Summary

This study is a single arm, single center trial to study the safety and efficacy of purified autologous bone marrow derived stem cells and mesenchymal stem cells for the treatment of children with cerebral palsy.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2016

Longer than P75 for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 13, 2017

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

4.1 years

First QC Date

February 25, 2017

Last Update Submit

March 15, 2020

Conditions

Cerebral Palsy

Keywords

stem cells

Outcome Measures

Primary Outcomes (1)

  • Changes in Motor Performance.

    GMPM (Gross Motor Performance Measure) as a standard measurement tool for assessing quality of movement.

    6 months

Secondary Outcomes (2)

  • Motor function studies

    1 year

  • Specific white matter tract analysis using MRI

    6 months

Study Arms (1)

Stem Cells

EXPERIMENTAL

Intravenous and Intrathecal transplantation of specific populations of purified bone marrow-derived stem cells and mesenchymal stem cells.

Biological: Stem Cell Therapy

Interventions

Stem Cell TherapyBIOLOGICAL

Intravenous and Intrathecal transplantation of purified autologous bone marrow-derived stem cells and mesenchymal stem cells.

Stem Cells

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Clinical evidence of a non-progressive motor disability due to brain dysfunction.
  • Willing to comply with all study procedures.
  • Gross Motor Function Classification Score level II-V

You may not qualify if:

  • Known history of:
  • Intractable seizures
  • Traumatic brain injury
  • Genetic disorder
  • Current Infection
  • Renal insufficiency
  • Hepatic disease
  • HIV+ (as demonstrated by positive blood test)
  • Immunosuppression
  • Infectious related neurological injury
  • Other etiologies such as degenerative, mitochondrial, and metabolic disorders
  • Normal brain MRI
  • Evidence of acute illness such as fever (temperature \> 37.5 C), vomiting, diarrhea, wheezing or crackles
  • Progressing neurological disease (Batten Disease, Leukodystrophies, Neurotransmitter disorders)
  • Microcephaly, macrocephaly, cortical malformations, or genetic disorders of dysgenesis
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2017

First Posted

March 13, 2017

Study Start

September 1, 2016

Primary Completion

October 1, 2020

Study Completion

January 1, 2021

Last Updated

March 17, 2020

Record last verified: 2020-03