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A comparison of the effect of autologous bone marrow-derived mononuclear cell therapy with standard treatment on ischemia parameters in diabetic patients with chronic limb-threatening ischemia

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519687-40-00
Acronym
BMMNC_CLI_002
Enrollment
60
Registered
2025-01-13
Start date
2020-09-11
Completion date
Unknown
Last updated
2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetic foot syndrome, lower limb ischemia

Brief summary

Comparison of cell therapy with standard treatment in several parameters: Assessment of tissue oxygenation – improvement of parameters of ischemia (measured by transcutaneous oxygen pressure andoptionally by other angiological methods), Comparison of cell therapy with standard treatment in several parameters: Clinical effect – wound healing, change in pain, rate of major amputation, amputation-free survival

Detailed description

Safety: adverse events - expected and unexpected, Assesment of study treatment by patients (psychological questionaries), To assess the relation between the quality of cell suspension and tissue oxygenation

Interventions

Sponsors

Institute For Clinical And Experimental Medicine
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Comparison of cell therapy with standard treatment in several parameters: Assessment of tissue oxygenation – improvement of parameters of ischemia (measured by transcutaneous oxygen pressure andoptionally by other angiological methods), Comparison of cell therapy with standard treatment in several parameters: Clinical effect – wound healing, change in pain, rate of major amputation, amputation-free survival

Secondary

MeasureTime frame
Safety: adverse events - expected and unexpected, Assesment of study treatment by patients (psychological questionaries), To assess the relation between the quality of cell suspension and tissue oxygenation

Countries

Czechia

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026