Generate Life Sciences Details Data Presented at the 2021 Annual ASRM and AABB Meetings

LOS ANGELES, Oct. 21, 2021 /PRNewswire/ -- Generate Life Sciences recently presented data from its research programs during this year's American Society for Reproductive Medicine (ASRM) Scientific Congress & Expo and the AABB (formerly known as the American Association of Blood Banks) Annual Meeting. Each of the data presentations highlight the company's belief in the potential of newborn stem cells to move regenerative medicine research forward, as well as improving industry standards to maintain high-quality reproductive and genetics services for families.

"Constantly moving the research field forward is imperative for improving reproductive health services," said Kate Brown, Ph.D., Senior Director of Science at Generate. "As such, we choose to focus on key areas that have an immediate impact on the families we serve, including the potential use of mesenchymal stem cells, or MSCs, derived from umbilical cord tissue to treat diseases, quality of sperm collected from donors during the pandemic, and the utility and advantages of a modular cleanroom for use in the isolation and expansion of MSCs. All of our presented studies addressed fundamental questions that are vital for setting up future research."

Key data and highlights from the ASRM oral presentation are detailed below:

Semen Analysis Parameters do not Change During Active Covid Infection in Qualified Sperm Donors

• When comparing collected sperm samples prior to, during and after COVID-19 infection, there were no significant differences in sperm concentration, percent motility, or ejaculate volume.
• Sperm samples from healthy donors who contracted COVID-19 are not adversely affected by the SARS-CoV-2 virus.

Key data and highlights from the AABB and ASRM poster presentations are detailed below:

Establishment of a Modular Cleanroom for cGMP Production of Cord Tissue MSCs Intended for Clinical Use

• A modular, off-the-shelf cleanroom and gowning chamber received ISO Class 7 and 8 certifications, respectively, within two months.
• Biweekly environmental monitoring showed no breach of action limits for viable air sampling, including for periods during which cell processing activities were performed.
• Measurements for air changes per hour and airborne particulate counts taken during the certification process indicated that the cleanroom could receive ISO Class 5 certification, if required.
• A modular cleanroom was shown to be a suitable alternative to a hardwall cleanroom for stem cell research.

Characterization of Umbilical Cord Tissue Mesenchymal Stem Cells Based on Donor Sex for Premature Ovarian Insufficiency

• No significant difference in cell yield, viability, and immunologic characteristics between MSCs derived from the umbilical cord MSCs between male and female newborns was found.
• Although donor-to-donor variability was observed, secretion of IL-6, FGF2, and TGF-β were similar in samples from male and female donors; VEGF secretion trended higher for female donors but was not statistically significant.

Clinical Experience With Sperm Donor Qualification Based on Expanded Carrier Screening Results

• Expanded carrier screening of sperm donor applicants led to 17 out of 803 total donors to be disqualified from participation in the donor program based on their results.
• Eight applicants were found to be either heterozygous or hemizygous for conditions that may convey significant health risks to carriers, and eight applicants were found to be either compound heterozygous or homozygous for autosomal recessive conditions.
• The eight applicants with two mutations for autosomal recessive disorders reportedly did not have any symptoms related to their genotype, highlighting a use case scenario well suited for expanded screening.

Comparison of Four National Reproductive Genetics Lab PGT-A Results From Vitrified Donor Eggs

• Controlling for oocyte quality, some preimplantation genetic testing for aneuploidies (PGT-A) labs report a significant difference in euploid blastocyst rate (EBR), which suggests that the genetics lab may be an important factor in EBR and pregnancy outcomes.
• Mosaic rate was significantly different between labs, while implantation rate and miscarriage rates remained the same.

Sixteen-year Longitudinal Study of U.S. Sperm Donors Continues to Demonstrate Declining Sperm Count and Motility

• Over the 16-year study period, there was a significant decline in average concentration, percent sperm motility and total motile sperm of sperm samples collected from 3,532 unique donors.
• There were significant decreases in sperm analysis parameters, except for ejaculate volume, within all geographic regions that could be examined.

Presentations and posters are available for viewing online at https://asrmcongress.org/ and https://www.aabb.org/annual-meeting.

About Generate Life Sciences

Generate Life Sciences™ is a global life sciences company helping families setting out to grow and protect their future, through guidance anchored in scientific advancements and services ranging from preconception into adulthood. Our longstanding brands — which include CBR® (Cord Blood Registry®), Insception Lifebank, Cells for Life, Cell Care, California Cryobank™, Donor Egg Bank USA™, NW Cryobank™, ReadyGen™, Kitazato USA™, and Donor Application™ — are pioneering leaders that have helped nearly one million families through reproductive, newborn stem cell, genetic screening, medical device, and healthcare technology services. Headquartered in Los Angeles, Generate operates facilities spanning from the United States and Canada to Australia, alongside frozen donor gamete distribution to more than 40 countries. Generate is a portfolio company of GI Partners, a private investment firm based in San Francisco.

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