FDA Approves 2nd Parkinson’s Disease Trial Testing Effects of Stem Cells on Quality of Life
The United States Food and Drug Administration (FDA) has approved a Phase 3 trial to test multiple infusions of fat-derived mesenchymal stem cells – those obtained from healthy donors – in people with Parkinson’s disease.
The Hope Biosciences Stem Cell Research Foundation (HBSCRF), which received authorization, already has a similar study underway that examines the effectiveness of such infusions using the patients’ own fat-derived mesenchymal stem cells.
This Phase 2 study (NCT04928287) – which is underway at HBSCRF, Sugar Land, Texas, and is currently recruiting participants – is testing a patient’s own (autologous) mesenchymal stem cells in parallel against a placebo. . Up to 24 patients will be able to enroll in this study; More information is available here.
In the new phase 3 trial, up to 60 men and women, aged 45 to 80, will be recruited. Eligible participants will have been diagnosed with mild to moderate Parkinson’s disease within the past two years. Those interested in learning more about this essay can call 346-900-0340.
The new trial will test the safety and efficacy of mesenchymal stem cells derived from donor fat, given as an intravenous infusion (into the vein), to improve a patient’s ability to conduct daily activities and improve its quality. of life.
Stem cells derived from adipose tissue, i.e. derived from fat, are advantageous to use because they can be acquired through a minimally invasive procedure called lipectomy, a surgical procedure aimed at removing fat from the body.
“We need to explore all facets of how fatty tissue-derived mesenchymal stem cells work in this disease,” said Donna Chang, founder of HBSCRF, in a press release.
Cells can be acquired from the patient – autologous – or from a donor, in which case it is called allogeneic. While a patient’s own stem cells have obvious advantages, such as a lower risk of transplant rejection, acquiring the number needed for infusion is often a major limitation. Additionally, cells need to be isolated, grown in the lab, and frozen for future use, which can be a timely process.
“Our main research focus has always been on autologous stem cells, but in COVID, for example, when we did three simultaneous prevention and treatment studies, we encountered a situation where people needed cells but no ‘didn’t have their stem cells in the bank,’ Chang mentioned.
The use of donor-derived cells circumvents some of these limitations because they are more readily available.
“To serve these patients, we entered the world of allogeneic studies and found safety intact,” Chang said.
“We recognize that there is a population of patients who need help immediately and could benefit from the use of allogeneic cells,” she said. “We see it as our responsibility to explore the possibilities, and we hope that these trials will provide valuable information individually and as a research body.”