Efficacy of combined treatment by autologous cell therapy and percutaneous transluminal angioplasty (PTA) versus the treatment by isolated PTA in diabetic patients with chronic limb-threatening ischemia

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512873-29-00

Acronym

BMMNC_PTA_003

Enrollment

110

Registered

2025-02-25

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-25

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

Conditions

chronic limb-threatening ischemia, diabetic foot ulcers

Brief summary

rate of major amputation, wound healing, TcPO2

Detailed description

other ischemia parameteres – ABI, laser doppler flowmetry, magnetic resonance spectroscopy; optional: microbiopsy of the muscle of the foot, other clinical effect – pain, safety: adverse events – expected and unexpected, assessment of quality of life (standardized questionnaires)

Interventions

DRUGSuspension of autologous mononuclear cells separated from bone marrow aspirate

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
rate of major amputation, wound healing, TcPO2	—

Secondary

Measure	Time frame
other ischemia parameteres – ABI, laser doppler flowmetry, magnetic resonance spectroscopy; optional: microbiopsy of the muscle of the foot, other clinical effect – pain, safety: adverse events – expected and unexpected, assessment of quality of life (standardized questionnaires)	—

Countries

Czechia

Outcome results

None listed

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