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Islet transplantation is a promising treatment of type 1 diabetes in selected cases. Results are however hampered by a relatively low number of islets surviving the transplantation into the liver, which currently is the site for transplantation. In the present study we compare a new transplantation site (intramuscular in the arm) to the golden standard (the liver) in patients undergoing kidney transplantation from the same donor. In half of the intramuscular transplanted patients, the islets will be mixed with mesenchymal stemcells from the recipient to, possibly, improve the immunological aspects of the transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraportal islet transplantation | Experimental | Subject randomized to the protocol with intraportal islet transplantation and kidney transplantation |
|
| Intramuscular islet transplantation | Experimental | Subject randomized to the protocol with intramuscular islet transplantation and kidney transplantation |
|
| Intramuscular transpl with stemcells | Experimental | Subject randomized to the protocol with intramuscular islet transplantation and where islets have been incubated autologous mesenchymal stemcells. Will also receive kidney transplant |
|
| Kidney transplantation only | Active Comparator | Subject that only undergoes kidney transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraportal islet transplantation | Procedure |
| ||
| Intramuscular islet transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| C-peptide derived from the Mixed Meal Tolerance Test (MMTT) | Percentage of patients in each study group reaching a systemic C-peptide derived from the MMTT above 0.1 nmol/L basal (fasting) and 90-min 0.3 nmol/L 75 (+/-5) and 365 days (+/-14) after kidney transplantation | 365 days (+/-14) after kidney transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kaija Salmela, MD PhD | Kidney Transplant Unit, Helsinki University Hospital, Helsinki, Finland | Principal Investigator |
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| Procedure |
|
| Intramuscular transpl with stemcells | Procedure |
|
| Kidney transplantation | Procedure | All patients will undergo kidney transplantation regardless of arm |
|
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007676 | Kidney Failure, Chronic |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016030 | Kidney Transplantation |
| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D016377 | Organ Transplantation |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
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