Celution

Paracrine Receives FDA Approval to Launch a U.S. Pivotal Trial in Patients With Hand Dysfunction Due to Diffuse Cutaneous Scleroderma

Retrieved on: 
Tuesday, January 25, 2022
Technology, FDA, Other Technology, Clinical Trials, Stem Cells, Biotechnology, Health, Pharmaceutical, General Health, Randomness, Disability, Inflammatory arthritis, Joint, University, STAR, Finger, Blood, Quality of life, Skin, Patient, Systemic scleroderma, Placebo-controlled study, FDA, RP, Adipose tissue, Contracture, Calcinosis, Multimedia, Hand, Pivotal trial, Hospital for Special Surgery, Vasculitis, Weill Cornell Medicine, Hospital, PMA, Medicine, Woman, Investigational device exemption, Skin discoloration, Technology, III, Physician, Safety, Inflammation, Disease, CEO, IDE, Pharmaceutical industry, Rheumatology, Scleroderma, Paracrine, Celution, Diffuse Scleroderma, PARACRINE, CELUTION, DIFFUSE SCLERODERMA

View the full release here: https://www.businesswire.com/news/home/20220125005813/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20220125005813/en/
    The STAR II Trial is a Pivotal Trial designed to provide a robust data set on the safety and efficacy of adipose derived regenerative cells (ADRCs) in the treatment of patients with hand dysfunction due to diffuse cutaneous scleroderma.
  • STAR II is a large, well-designed pivotal phase III trial that assesses the clinical benefits of Celution-processed ADRCs in patients with diffuse cutaneous scleroderma and hand dysfunction, a large unmet need, continued Dr. Khanna.
  • Paracrine, Inc. is a biotechnology company developing the worlds first device-based disease modifying cell therapy platform to treat debilitating chronic conditions.
  • An estimated 40,000 patients have diffuse cutaneous SSc, the more severe disease with significant hand dysfunction.

Paracrine Receives Full FDA Approval of Investigational Device Exemption (IDE) to Launch a U.S. Pivotal Trial in Patients With Diabetic Foot Ulcers

Retrieved on: 
Wednesday, November 17, 2021
Health, FDA, Medical Devices, Diabetes, Clinical Trials, Pharmaceutical, Biotechnology, Patient, Investigational device exemption, IDE, Sale, Safety, DFU, Technology, Diabetes, Adipose tissue, PMA, American Diabetes Association, Foot, Diabetic foot ulcer, Physician, Treatment, Risk, Biotechnology, Randomness, Pivotal trial, FDA, Ulcer, Pharmaceutical industry, Paracrine, Celution, Diabetic Foot Ulcers, PARACRINE, CELUTION, DIABETIC FOOT ULCERS

The ASCEND Trial is a Pivotal Trial designed to provide a robust data set on the safety and efficacy of ADRCs in the treatment of patients with DFUs.

Key Points: 
  • The ASCEND Trial is a Pivotal Trial designed to provide a robust data set on the safety and efficacy of ADRCs in the treatment of patients with DFUs.
  • The trial will include up to 291 patients at 25 clinical sites in the U.S. Trial results will be submitted in a Premarket Approval (PMA) application to the FDA to support regulatory approval.
  • Paracrine, Inc. is a biotechnology company developing the worlds first device-based autologous multifactorial cell therapy platform to treat debilitating chronic conditions.
  • Diabetic foot ulcers (DFUs) are responsible for more hospital admissions than any other diabetic complication.