Management of of retinitis pigmentosa by Wharton’s jelly derived mesenchymal stem cells: preliminary clinical results
The intention of this study is to find out if the stem cells living inside Wharton’s Jelly in the umbilical cord would have positive properties on vision (eyesight).
Material and Methods
This phase 3 clinical trial took place between April 2019, and October 2019 in Turkey, at Ankara University Faculty of Medicine Department of Ophthalmology. 32 participants were part of this study. After stem cells from Wharton’s Jelly were placed on the participants’ eyes. They were monitored closely for 6 months, followed by consistent evaluation of examinations. Everyone went through a thorough eye exam, corrections on visual acuity, optical angiography, and procedures related to visual field, multi-focal, and full field electroretinography. Statistical data was gathered over the course of the 6 month examination and monitoring period.
Statistics were used in calculating data over a course of 6 months during this clinical trial. During follow up monitoring, no serious side effects were found having to do with the 2 surgical procedures involved (multi-focal and full field flicker electroretinography), nor the application of stem cells from Wharton’s Jelly.
Retinitis Pigmentosa (RP), a genetic vision disease, may lead to blindness, having to do with outer retinal degeneration. No matter what type of genetic mutation this is, stem cells derived from Wharton’s Jelly in the umbilical cord, appeared to be a sound and safe alternative. During the 6 month monitoring period, no serious side effects showed up. Though long term side effects are still unknown, these stem cells from the umbilical cord (Wharton’s Jelly) is a good way to provide treatment while avoiding injection. Closer studies show that consistent long term monitoring is necessary to see if there is duration of efficacy and application frequency.
Background on Retinis Pigmentosa
This disease affects the retinal pigment epithelium (RPE). It forms the outer blood retinal barrier between photo receptor cells and choroidal blood cells. Photo receptor cells are absolutely important for the RPE. The RPE is where glucose gets changed to ATP, protein making, and metabolic wastes take place. The RPE is where many protein factors and receptors are made in the RPE. The making of protein factors (peptide fragments), is the work of more than 260 genes in the RPE. Any gene mutations can lead to retinal damage. Retinal damage can come from genetics, such as retintis pigmentosa, Stargardt’s disease, choroideremia, vitelliform dystrophy and Bietti’s crystalline dystrophy. People can also get retinal damage by genetic mechanisms, such as macular degeneration due to aging. With retinal damage, gradual loss of RPE and photo receptors takes place, irrespective of the cause or origin.
Stem cells from the umbilical cord, using Wharton’s Jelly, has proven to show paracrine and immunomodulatory advantages. This type of stem cell therapy produces trophic factors that trigger RPE, or similar properties made by RPE. In animal experiments, this type of regenerative medicine has proven to be effective in slowing down retinal damage progression, and saving photo receptors that are laying in the dormant phase. This stem cell therapy has been proven to inhibit chronic inflammation and minimize apoptosis in animal studies that have neurodegenerative and ischemic retinal disorders. They also stimulate progenitor cells in the retina region and are responsible for independent repairing mechanisms.
The goal of this clinical study, is to examine Wharton’s Jelly / umbilical cord stem cell therapy as a regenerative medicine alternative on treating retinitis pigmentosa, leading to “outer retinal degeneration”. Microperimetry, electrophysiology and spectral domain optical coherence tomography (SD-OCT) were used as specific procedures on closely looking into the functional and structural properties. According to the team leading this clinical study, this is the first clinical study that is relying on a variants of (RP) to this degree.