Clinical Trial Results:
A Phase 1b, open label, uncontrolled non-randomised single dose study to examine the safety of topically applied bone marrow derived allogeneic mesenchymal stromal cells (REDDSTAR ORBCEL-M) seeded in a collagen scaffold to patients with non-healing neuroischaemic diabetic foot wounds
Summary
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EudraCT number |
2015-005580-16 |
Trial protocol |
DK |
Global completion date |
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
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Results information
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Results version number |
v1(current) |
This version publication date |
27 Dec 2023
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First version publication date |
27 Dec 2023
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Other versions |
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Summary report(s) |
Novel topical allogeneic bone-marrow-derived mesenchymal stem cell treatment of hard-to-heal diabetic foot ulcers |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.