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About ORBCEL-C™
The POLARISE study is investigating a cell therapy called ORBCEL-C™ in people with PSC.
ORBCEL-C™ is a cell therapy made of Mesenchymal Stromal Cells (MSC). MSC are found in every part of our body, and 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. In this trial the research team want to see if patients with PSC can be treated safely with this therapy and specifically, they want to see if ORBCEL-C™ can restore the balance between certain immune cell types in the blood.
| Trial Name | POLARISE: A single arm, multi-centre, phase II multi-disease 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. |
| ISRCTN registry number | ISRCTN80103507 |
| Phase | II |
| Intervention | Infusion |
| Recruiting now? (or start date) | Fully recruited |
| Liver disease diagnosis | Primary Sclerosing Cholangitis (PSC) |
| Age | Age ≥ 18 years at Visit 1a (screening) |
| Females: can I be pregnant? | No |
| Is IBD allowed? | Yes – specific PSC with IBD eligibility criteria |
| Is there an ALP (alkaline phosphatase) requirement? | Yes |
| Can I take UDCA (Urso)? | Yes – no modifications to UDCA dose allowed during the trial or in the 90 days prior to trial entry |
| Can I take part if I have a stent? | No |
| Are recent acute cholangitis attacks allowed? | Patients are not allowed in the trial if there is documented evidence of cholangitis within 90 days of Visit 1a (screening), or if they have required antibiotics for presumed cholangitis
Patients are also excluded if they are taking prophylactic antibiotics for recurrent cholangitis |
| Can I take part if I have had a liver transplant? | No |
| Is cirrhosis allowed? | Patients with decompensated chronic liver disease are excluded. |
| Previous studies and information | MERLIN Trial – Phase IIa clinical trials using ORBCEL-C™ PSC and autoimmune hepatitis (AIH)
|
| Travel expenses? | When you come into hospital for your trial visits, reasonable travel expenses incurred by you and/or you companion/carers can be reimbursed. A value of up to £30 per visit can be repaid on production of receipts. If you travel to hospital by car, travel will be reimbursed at the standard NHS patient reimbursement rate of your local NHS trust |
| Procedures and tests include: | Heart rhythm scan (electrocardiogram (ECG) - Visit 1a only)
Blood tests Medication review Symptom and side-effects review Body system exam (vitals and physical examination) Pregnancy tests (if applicable) Liver scan (FibroScan®) QoL Questionnaires/IBD Diaries (where applicable) |
| How many Study Visits? How long will each study visit be? | 12 Visits (2 treatment visits; 10 follow-up visits) and 2 Telephone Calls. Treatment visits will take up to 6 hours to complete. All other visits will take up to 2 hours. |
| Duration of Study (treatment duration/follow-up) | 24 months |
| Basic design of study eg placebo etc | All patients will be given two doses of ORBCEL-C, one at Visit 2 and one at Visit 4. |
| Patient Information
How is this intervention thought to work and what is it thought to do? |
ORBCEL-C™ is a cell therapy made of Mesenchymal Stromal Cells (MSC). MSC are found in every part of our body, and 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. In this trial the research team wants to see if patients with PSC can be treated safely with this therapy and specifically, they want to see if ORBCEL-C™ can restore the balance between certain immune cell types in the blood. |
| Link to Sponsor | https://www.birmingham.ac.uk/research/crctu/about-us.aspx |
| Trial Name (and trial nickname) | POLARISE: A single arm, multi-centre, phase II multi-disease 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. |
| ClinicalTrials.gov Identifier | This trial is in the process of being registered on the ISRCTN website |
| Phase | II |
| Intervention | Infusion |
| Recruiting now? (or start date) | Yes |
| Participating Centres and Contact (if possible) | Queen Elizabeth Hospital, Birmingham (Open)
Queens Medical Centre, Nottingham (In Set Up) Additional sites to be added |
| Central Contact of individual contacts unavailable | polarise@trials.bham.ac.uk |
| Liver disease diagnosis | Primary Sclerosing Cholangitis (PSC) |
| Age | Age ≥ 18 years at Visit 1a (screening) |
| Females: can I be pregnant? | No |
| Is IBD allowed? | Yes – specific PSC with IBD eligibility criteria |
| Is there an ALP (alkaline phosphatase) requirement? | Yes |
| Can I take UDCA (Urso)? | Yes – no modifications to UDCA dose allowed during the trial or in the 90 days prior to trial entry |
| Can I take part if I have a stent? | No |
| Are recent acute cholangitis attacks allowed? | Patients are not allowed in the trial if there is documented evidence of cholangitis within 90 days of Visit 1a (screening), or if they have required antibiotics for presumed cholangitis
Patients are also excluded if they are taking prophylactic antibiotics for recurrent cholangitis |
| Can I take part if I have had a liver transplant? | No |
| Is cirrhosis allowed? | Patients with decompensated chronic liver disease are excluded. |
| Previous studies and information | MERLIN Trial – Phase IIa clinical trials using ORBCEL-C™ PSC and autoimmune hepatitis (AIH)
|
| Travel expenses? | When you come into hospital for your trial visits, reasonable travel expenses incurred by you and/or you companion/carers can be reimbursed. A value of up to £30 per visit can be repaid on production of receipts. If you travel to hospital by car, travel will be reimbursed at the standard NHS patient reimbursement rate of your local NHS trust |
| Procedures and tests include: | Heart rhythm scan (electrocardiogram (ECG) - Visit 1a only)
Blood tests Medication review Symptom and side-effects review Body system exam (vitals and physical examination) Pregnancy tests (if applicable) Liver scan (FibroScan®) QoL Questionnaires/IBD Diaries (where applicable) |
| How many Study Visits? How long will each study visit be? | 12 Visits (2 treatment visits; 10 follow-up visits) and 2 Telephone Calls. Treatment visits will take up to 6 hours to complete. All other visits will take up to 2 hours. |
| Duration of Study (treatment duration/follow-up) | 24 months |
| Basic design of study eg placebo etc | All patients will be given two doses of ORBCEL-C, one at Visit 2 and one at Visit 4. |
| Patient Information
How is this intervention thought to work and what is it thought to do? |
ORBCEL-C™ is a cell therapy made of Mesenchymal Stromal Cells (MSC). MSC are found in every part of our body, and 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. In this trial the research team wants to see if patients with PSC can be treated safely with this therapy and specifically, they want to see if ORBCEL-C™ can restore the balance between certain immune cell types in the blood. |
| Link to Sponsor | https://www.birmingham.ac.uk/research/crctu/about-us.aspx |