InD application for treatment of rheumatoid arthritis in interstitial stem cell BX-U001, approved by FDA
Last Update: 2020-06-16
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Baylx announced that the U.SFood and Drug Administration (FDA) has approved a new research drug (IND) application for its fresh non-frozen human umbilical cord interstitial stem cell (hUC-MSC) product BX-U001 for clinical studies in patients with rheumatoid arthritis (RA)"We are pleased to have our first IND license in the U.S., and we look forward to working with researchers to advance Baylx's BX-U001 for the treatment of rheumatoid arthritis," said DrWenbin Liao, Chief Executive Officer of BaylxPrior to indiapproval in the United States, Baylx's strategic partner, Beijing Belle Biosciences Co., Ltd., has obtained IND approval from the National Drug Administration (NMPA) to conduct clinical testing of the stem cell product in RA patientsIt is also the first in China to approve IND in stem cell treatment for RA or autoimmune diseases"The difference between our stem cell candidates and other products is that stem cells are harvested shortly before injection to the recipient to keep the cells fresh and to keep them optimally active and biologically active without any cryopreservation agents (e.gDMSO)This is in line with our firm belief that the health of cells when administered is an important factor in their therapeutic effectivenessMsC is known to have a huge potential treatment for many inflammatory and other diseasesBaylx has also developed hUC-MSC products for use in other indications, including inflammatory bowel disease (IBD), multiple sclerosis, cirrhosis, stroke, etc"Current interventions do not prevent the development of injury in RA patientsWe believe that BX-U001 has the potential to suppress inflammation, reduce or prevent degenerative joint changes, so that patients can not only relieve symptoms, but also avoid disability caused by later-disease joint deterioration"
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