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Leap forward in cell therapy manufacturing: data reveals highly reproducible stem cell expansion in 10L bioreactors, with exponential growth and preserved quality

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TreeFrog Therapeutics announces the results of two runs of hiPSC amplification in 10L bioreactors at the Annual Meeting of the International Society for Stem Cell Research.

BORDEAUX, France, Jun. 21, 2021 — Today, French cell therapy company TreeFrog Therapeutics released data showing the mass production of human induced pluripotent stem cells (hiPSC) produced with their proprietary C-Stem™ technology in 10L bioreactors at the 2021 Annual Meeting of the International Society for Stem Cell Research (ISSCR). The data shows the output from two batches with indistinguishable expansion curves, demonstrating a high degree of reproducibility, while cell analysis showed conservation of stem cell quality. [Read more…]

Kite and Shoreline Biosciences to Develop iPSC-Derived Cellular Immunotherapeutics

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Kite and Shoreline Biosciences Enter Into Strategic Partnership to Develop Novel Allogeneic Cell Therapies
Partnership Follows Kite’s Investment in Shoreline’s Recent Series A Financing

June 17, 2021, SANTA MONICA, Calif. & SAN DIEGO — Kite, a Gilead Company (Nasdaq: GILD), and Shoreline Biosciences, Inc. (Shoreline), a biotechnology company developing intelligently designed allogeneic off-the-shelf, standardized and targeted natural killer (NK) and Macrophage cellular immunotherapies derived from induced pluripotent stem cells (iPSC) for cancer and other serious diseases, today announced a strategic partnership to develop novel cell therapies across a variety of cancer targets. [Read more…]

Organicell Announces Positive Results Of Their Expanded Access Trial For The Treatment Of Mild To Moderate COVID-19 Using Zofin™

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Miami, FL (June 15th, 2021) – Organicell Regenerative Medicine, Inc. (OTCMKTS: BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, today announced the outcome of their expanded access (EA) intermediate size patient population trial (NCT04657406) which: [Read more…]

Regenerative Outcomes Establishes Newest Location – Regenerative Outcomes Miami, Announces Appointment Of Maharaj as Clinical Trial Management Head

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Regenerative Outcomes Miami now offers affordable Clinical Trial Management Support service options, provided by its expert team based in Miami, Florida.

Nashville, TN, and Miami, FL, JUNE 15, 2021 — Regenerative Outcomes LLC, a Tennessee-based company providing regulatory application and translational development services to regenerative medicine biotechnology companies, expands operations outside of Nashville facilitates to its new location at popular South Beach, Miami, Florida.

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Direct Biologics Receives FDA Approval to Proceed with Second ExoFlo IND for Post-Acute COVID-19 Syndrome and Chronic Post-COVID-19 Syndrome

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  • Extracellular Vesicle Isolate Product ExoFlo Shows Strong Potential to Treat COVID-19, Post-Acute COVID-19 Syndrome, and Chronic Post-COVID-19 Syndrome
  • 60-patient trial to be conducted nationally at ambulatory infusion sites

AUSTIN, Texas, June 9, 2021 – Direct Biologics, a market-leading innovator and cGMP manufacturer of regenerative biologic products, announced today that it has received FDA approval to initiate a Phase I/II trial under an Investigational New Drug (IND) protocol for the use of ExoFlo™ in the treatment of Post-Acute COVID-19 Syndrome. This trial is Direct Biologics’ second approved IND, and it represents the first IND ever approved by FDA for the use of extracellular vesicles (EVs) to treat Post-Acute COVID-19 syndrome, Chronic Post-COVID-19 syndrome, or any post-viral syndrome. [Read more…]

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