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The effectiveness and safety of quality and quantity mononuclear cells in treating chronic limb ischemia patient

The effectiveness and safety of quality and quantity mononuclear cells in treating chronic limb ischemia patient

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220502003
Enrollment
20
Registered
2022-05-02
Start date
2022-05-12
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Limb ischemia Limb ischemia, stem cell, peripheral blood mononuclear cell, quality and quantity mononuclear cells, amputation, wound healing

Interventions

The patients will receive a subcutaneous injection of Granulocyte colony-stimulating factor (G-CSF) for 3 days. Venous blood 30 cc was collected by venous puncture of superficial vein at forearm. MNCs
Experimental Biological/Vaccine,Active Comparator Biological/Vaccine
QQMNCs injection, PBMNC injection

Sponsors

Faculty of Medicine, Siriraj Hospital, Mahidol university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with CLI presented with rest pain , non-healing ischemic ulcer and toe gangrene for 3 months

Exclusion criteria

Exclusion criteria: Gangrene extended proximally to forefoot area Recent myocardial infarction Severe valvular heart disease After organ transplantation Cardiomyopthy( EF< 25%) Liver failure Coagulopathy HIV Malignancy

Design outcomes

Primary

MeasureTime frame
Limb saving 3 ,6 , 9 , 12 months Observation,Wound healing 3 ,6 , 9 , 12 months Observation,Rest pain relieve 3 ,6 , 9 , 12 months Observation

Secondary

MeasureTime frame
Transcutaneous oxygen measurement 3,6,9,12 months Transcutaneous oxygen measurement, Ankle brachial index 3,6,9,12 months Ankle brachial index,Toe pressure Brachial index 3,6,9,12 months Toe pressure Brachial index

Countries

Thailand

Contacts

Public ContactNuttawut Sermsathanasawadi

Faculty of Medicine Siriraj Hospital

nuttawut@gmail.com024198021

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026