POLARISE

• Research type

  Research Study

• Full title

  A single arm, multi-centre, phase II basket trial investigating the safety and activity of the use of ORBCEL-C™ in the treatment of patients with Primary Sclerosing Cholangitis, Rheumatoid Arthritis, Lupus Nephritis and Crohn’s Disease

• IRAS ID

  272535

• Contact name

  Philip Newsome

• Contact email

  P.N.Newsome@bham.ac.uk

• Sponsor organisation

  University of Birmingham

• Eudract number

  2019-003404-13

• Duration of Study in the UK

  3 years, 0 months, 1 days

• Research summary

  We want to see if patients with Primary Sclerosing Cholangitis (PSC), Rheumatoid Arthritis (RA), Lupus Nephritis or Crohn's Disease can potentially be treated safely with two doses of ORBCEL-C™. Specifically, we want to see if ORBCEL-C™ can restore the balance between certain immune cell types in the blood. Although patients may not directly benefit from taking part in this trial, they will help to see if ORBCEL-C™ can be used in the future as a new or alternative treatment.
  ORBCEL-C™ is made from Mesenchymal Stromal Cells (MSC). MSC are thought to play a role in the repair and renewal of tissue as well as reducing inflammation. When MSC have been used as a cell therapy in patients with inflammatory diseases, they have been shown to reduce damage and inflammation to tissue. Tests within our laboratory have shown ORBCEL-C™ to be safe. This is the first time this form and dose of ORBCEL-C™ has been used in a clinical trial.
  A total of 60 patients with either PSC, RA, Lupus Nephritis or recurrent Crohn’s Disease (15 from each) will be recruited to the trial. The trial will be offered at a number of hospitals across the UK. Patients will be involved in the trial for 13 months, and will be required to attend clinic an extra 8/ 9 times additional to their normal treatment, disease cohort dependent. Trial visits will last between 2 and 5 hours, and include the collection of health history, heart rhythm scan (or Electrocardiogram [ECG]), body systems exam, disease specific measures, blood test, pregnancy tests (if applicable), medication reviews, patient questionnaires and possible symptom & side-effect review. In addition, patients with RA or Crohn’s Disease will have two biopsy samples collected. Patients will have the option to complete patient questionnaires either electronically, or in a paper booklet.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  21/LO/0475

• Date of REC Opinion

  17 Aug 2021

• REC opinion

  Further Information Favourable Opinion