Stem Cell and Conditioned Medium for Cerebral Palsy

A currently recruiting study using intrathecal injections of UC-MSCs and conditioned medium along with standard physiotherapy in order to improve gross motor function, cognitive function, and chemical factors for patients with cerebral palsy. Only for children ages 6 months- 3 years old. This study is in phase 2 and is estimated to be completed at the end of this year 2020.


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

An active but not recruiting trial in phase 2 designs a study where three separate groups receive intrathecal injections of different treatment to compare the effects of each: hematopoietic stem cells derived from an umbilical cord, mesenchymal stem cells derived from an umbilical cord, and a control group receiving no injection. This study is for children with cerebral palsy ages 4-14 in hopes to improve developmental functions, gross motor function, and spasticity.


Bone Marrow-Derived Stem Cell Transplantation for the Treatment of Cerebral Palsy

Another active but not recruiting study in phases 1 and 2 uses intravenous and intrathecal injections of purified autologous bone marrow derived stem cells and mesenchymal stem cells in children ages 2-12 in hopes of improving gross motor function, and improvement of white matter. This is a single group assignment so each patient will receive the same treatment of both injections. The study intended on being completed in January of 2021.


Improvement in Gross Motor Function and Muscle Tone in Children with Cerebral Palsy Related to Neonatal Icterus

A completed study in phase 2 looks to alleviate neonatal icterus (jaundice), which is commonly found in children with cerebral palsy, by using autologous bone marrow mononuclear stem cells in intrathecal injections. The patients received one injection at the start of the trial, and another six months after. The outcome of this study is to improve gross motor function and muscle tone, both of which can are affected by neonatal icterus. The results show that no severe events happened during the study. 12 patients did experience a fever without infections and nine patients had vomiting which was managed through medications. Gross motor function and muscle spasticity showed improvement three months and six months after first transplantation. The researchers concluded that the treatment resulted in a safe and effective therapy for patients with cerebral palsy.


Mechanism of Allogeneic UCB Therapy in Cerebral Palsy

This is an active, but not yet recruiting study that is piloted off of a previous study investigating the same thing. In phases 1 and 2, this study aims to investigate how protein expression changes in response to factors regarding the umbilical cord blood transplantation (number of transplanted cells, serum levels of immunosuppressant, etc.) for children with cerebral palsy. The researchers’ target proteins they want to examine are pentraxin, TLR4, and ubiquitine due to the immune functions these proteins are responsible for. This is a single group assignment where the treatment involves an intravenous infusion of umbilical cord blood containing total nucleated cell count with three HLA mismatch; this is due to the findings that 3 HLA mismatches has significant effects on patients using UCB therapy. The study will examine gross motor function as well as chemical levels with changes in protein expression.


Neuroregenerative Potential of Intravenous G-CSF and Autologous Peripheral Blood Stem Cells


This completed study in phases 1 and 2 is a cross-over study examining the effects of an infusion of G-CSF (granulocyte colony-stimulating factor) which is a glycoprotein responsible for producing granulocytes for the immune system and stem cells and then releasing them into the bloodstream. The study follows with using an infusion of autologous mobilized peripheral blood mononuclear cells (mPBMCs), all to help improve the neurological function in children with cerebral palsy. mPBMCs are precursor cells for MSC’s, so this study takes a different route in terms of normal stem cell therapy for treatment that the researchers believe is a better way to treat children with CP. The treatment involves administering G-CSF for 5 days, then collecting mPBMCs from all patients. Patients are then randomized to receive either an injection of mPBMCs or a placebo drug. Six months after, a cross over will happen where the two groups will switch treatments. The results concluded to be very good: no adverse effects to treatment, and 42.6% of patients responded with higher neurodevelopmental scores after the trial ended. The researchers concluded that using G-CSF was the main factor that caused improved neurodevelopmental function, and that more studies need to be done to examine how the two infusions can make more of an impact.


Safety and Effectiveness of Banked Cord Blood or Bone Marrow Stem Cells in Children with Cerebral Palsy (CP). (ACT for CP)

This completed study in phase 2 examines how using banked cord blood is different than using bone marrow stem cells for treatment in children with CP. There will be a third group that receives a placebo drug. The placebo group can opt to receive either or treatment of stem cells a year after the study began. The goal of this study is to determine which type of stem cells is more efficient in treating kids with CP. No results have been posted for this study.



Multiple Transplantation of Bone Marrow Derived CD133 Cell in Cerebral Palsy

This completed study in phases 1 and 2 looks into using several transplantations of autologous bone marrow derived stem cells for children with CP. After the first set of injections, the patients will be accessed for six months until the next set of injections. The focus is to measure motor improvement, sensory dysfunction, balance improvement, and spasms. The results had been posted to the sponsor’s website The Royal Institute. They concluded that no adverse effects happened after treatment and that motor and cognitive functions improved after both injections.

GMFM; Gross Motor Functional Measurement, FIM+FAM; Functional Independence Measure+
Functional Assessment Measure in patients who are treated with bone marrow derived CD133 cells (before, 0 and six months 6, after intrathecal injection)


Outcomes of Stem Cells for Cerebral Palsy

This completed trial in phase 2 looks into using autologous bone marrow mononuclear stem cells for patients with cerebral palsy. This is a single group assignment where the treatment involves 2 intrathecal injections of the stem cells, one at baseline and the next injection three months after. The main focus of this study is to evaluate gross motor function, changes in muscle tone, developmental changes, adverse events, and overall quality of life. After the study ended, the researchers found that 95% of the patients showed improvement. PET-CT scans reveal high metabolic improvement six months after treatment to where the researchers could conclude that “The results of this study demonstrate that cellular therapy may accelerate the development, reduce disability, and improve the quality of life of patients with cerebral palsy”.

“Improvements in PET-CT scan brain: PET-CT scan images of (A) pre- and (B) postintervention showing increased metabolic activity in various areas. Blue areas indicate hypometabolism, green areas indicate normal metabolism, yellow areas indicate slightly high metabolism, and red areas indicate high metabolism”




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