Altamonte Springs, FL, October 29, 2021 — Cord for Life®, a full-service cord blood bank with over 25 years of experience, today announced plans to conduct a clinical trial to treat lower back pain arising from the Sacroiliac Joint (SIJ) using a biological therapeutic derived from umbilical cord blood.
The company has received FDA authorization of an Investigational New Drug (IND) Application for a Phase 1a, open label, dose ranging study to assess the safety, tolerability, preliminary efficacy and dose effect of its allogeneic individual donor umbilical cord blood-derived stem cell product in patients with lower back pain of the Sacroiliac Joint (SIJ).
The Clinical Trial arrangements are being finalized with expectation of an early 2022 enrollment start. The initial trial includes nine patients with lower back pain, who will receive a range of dosing regimens using the company’s PREMIERMAXCB® product. Following injection, patients will be monitored for 12 months.
“Having been involved in the release of over 2,200 cord blood units for transplants, research, and clinical trials, Cord for Life® is excited about the potential for cord blood in therapeutic medicine,” commented Donald L. Hudspeth, BSCLS, MT (ASCP) General Manager and Director of International Projects for Cord for Life®. “We are committed to supporting research that can unlock the role of cord blood in the safe and effective treatment for both chronic and acute conditions that can improve the quality of life for individuals in need.”
PREMIERMAXCB® is a newly developed investigational biological therapeutic derived from umbilical cord blood. The PREMIERMAXCB® product line is ideal for smaller, localized treatments. The PREMIERMAXCB® PLATINUM product contains 1mL of a cellular and protein mixture, with an average of 30 million nucleated cells, that has demonstrated promising results in early research testing.
Manufactured under cGMP conditions in the company’s state of the art clean room facility, the products are tested to the highest standards for safety, quality, identity, purity and potency. PREMIERMAXCB® is currently available for research use only.
About Cord for Life®
Since 1995, Cord for Life® has been a leader in cord blood collection, processing, and storage. We were the first cord blood bank to accept both private storage and publicly donated cord blood collections from anywhere in the continental United States. Our team of scientists and cord blood banking professionals are leaders in the cord blood collection community who have helped clients around the world successfully launch and grow their organization’s cord blood collections. Our team members are passionate about our mission to Save Lives.
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For information pertaining to Cord for Life®, visit: www.cordforlife.com