Clinical Trials of KNF

Cerebral palsy (CP) is a clinical condition that causes paralysis, resulting in functional disabilities and developmental issues in children. This clinical condition can limit daily functional abilities and disrupt the child's quality of life related to health. It can even lead to death if there is a deterioration in the clinical condition and simultaneous clinical complications, such as complications. neurologis, kardiovaskular or breathing (Ashrafi et al., 2018).

Most physical disabilities can be improved through rehabilitation therapy; additionally, some medications are indicated to alleviate seizures and movement difficulties (Delgado et al., 2010). In some cases, neurosurgical and orthopedic interventions can help to enhance recovery. However, the success of these therapies is limited as there is no treatment targeting brain injuries (Kiasatdolatabadi et al., 2017). Therefore, new therapy options are needed to further improve physical function and quality of life for patients.

Lately, stem cell therapy has become a healing-targeted treatment strategy. Stem cells originating from human umbilical cord tissue, commonly known as umbilical cord mesenchymal stem cells (UCMSCs) are a type of stem cell that offers ease of accessibility, low immunogenicity, and immunosuppressive potential compared to other types of stem cells, thereby reducing the risk of rejection (Gu et al., 2020). Animal studies on UCMSCs in cerebral palsy (CP) have shown functional improvement with a reduction in brain lesions detected after transplantation (Morioka et al., 2017; Zhou et al., 2015; Zhang et al., 2014). Meanwhile, clinical case reports have indicated improved gross motor and cognitive functions following transplantation (Okur et al., 2018).

Currently, ProSTEM along with the research team led by Prof. Dr. dr. Hardiono D Pusponegoro, Sp.A (K), is conducting a clinical trial titled "Clinical Trial of Therapy Allogenic Umbilical Cord Mesenchymal Stem Cells  Conditioning Media (UCMSCs-CM) and Allogenic Umbilical Cord Mesenchymal Stem Cells (UCMSCs)" in children with Cerebral Palsy at the National Brain Center Hospital and Columbia Asia Hospital, Jakarta, with the approved ethical clearance number: No.UM.01.05/12/056/2019, is expected to enhance services in the field of neurology, particularly in therapy cerebral palsy

Refrences :

1 Ashrafi F, Zali AR, Pakdaman H, Behnam B, Ahmadi MA, Harandi A, et al. 2018. A review on stem cell therapy in cerebral palsy with a focus on motor function improvement. Arch Neurosci. 5(1):e59387.

2 Delgado MR, Hirtz D, Aisen M, Ashwal S, Fehlings DL, McLaughlin J, et al. 2010. Practice parameter: pharmacologic treatment of spasticity in children and adolescents with cerebral palsy (an evidence-base review). American Academy of Neurology. 74: 336-343.

3 Gu J, Huang L, Zhang C, Wang Y, Zhang R, Tu Z, et al. 2020. Therapeutic evidence of umbilical cord-derived mesenchymal stem cell transplantation for cerebral palsy: a randomized, controlled trial. Stem Cell Research & Therapy. 11:43.

4 Kiasatdolatabadi A, Lotfibakhshaiesh N, Yazadankhah M, Barough SA, Jafarabadi M, Ai A, et al. 2017. The role of stem cells in the treatment of cerebral palsy: a review. Mol Neurobiol. 54(7): 4963-4972

For research criteria and registration details, you can access the following link :

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