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POLARISE

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.

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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.

 

FAQs

Key information

 

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.
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)

 

REALIST Trial – Phase I clinical trial using ORBCEL-C™ to treat acute respiratory distress syndrome (ARDS)

 

 

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)

 

REALIST Trial – Phase I clinical trial using ORBCEL-C™ to treat acute respiratory distress syndrome (ARDS)

 

 

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

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