An interventional study of Pall Celeris System, point of care device for human cell therapy in Critical Limb Ischemia and Diabetic Foot, sponsored by Ospedale San Donato. Completed. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-02-05.
Sponsored by Ospedale San Donato · Not applicable, Interventional, and Treatment
The objective of this trial is to determine whether PBMNCs in diabetic patients with critical, non revascularizable limb ischemia can prevent major amputation and affect mortality and healing.
This is an interventional study with historical control group carried out to assess as primary outcome major amputations, overall mortality, number of healed patients in group of patients who received repetitive intra-muscular implant of PBMNCs (3 times; 4-week interval) in comparison to a historical internal control group with a 1:1 case-control ratio. Secondary outcomes are TCPO2, healing time and rest pain.
No-option critical limb ischaemia is defined by evidence of no run-off pedal vessels, failure after several percutaneous intervention and no longer possible re-intervention, failure after infra-genicular bypass grafting, no-walking capacity with severe comorbidities unfit for surgical or endovascular procedures.
Inclusion criteria are: a) ulcers with inadequate perfusion, as indicated by a transcutaneous oxygen pressure value (TcpO2) \<30 mmHg; b) ulcers with grade I or II or III and stage C as defined by the Texas University Classification System or W1,2,3 - I 3 - FI 0,1 as defined by the WiFI Classification System c) not eligible for angioplasty or vascular surgery or following failed revascularization; d) possibility to save foot support.
Exclusion criteria are: a) lesion site above the tibial-tarsal joint; b) moderate or severe infection according by the WiFI classification system; c) NYHA class IV; d) Anemia (Hb\<8g/dl); e) coagulation disorder/thrombocytopenia (PLT\< 50,000 per microliter); f) active cancer/leukemia or lymphoma hematological disease.
Standard of care in both groups includes: diabetes control maximization by the diabetologist, comprehensive foot assessment by the nurse together with the diabetologist, including determination of vibration perception threshold, 10-g monofilament test and TcpO2 measurement, dressings, off-loading and systemic therapy according to the IWGDF guidelines .
Informed consent for participation in the study during the progress of the clinical trial is obtained from all subjects.
Concentration of PB-MNCs autologous cell therapy is produced by a filtration-based point-of-care device with the intended for use intra-operatively, from 120 mL of anticoagulated blood. All the procedures are performed in operatory room with anaesthesiologic support (propofol and/or peripheral block). Blood withdrawal (120 ml) is collected through a peripheral venous access, than loaded and gravity filtration is allowed in about 10 minutes. During filtration, MNCs are captured in the filter while plasma, platelets (PLTs) and red blood cells (RBCs) are not retained. After appropriate surgical debridement of the wound bed multiple perilesional and intramuscular injections of PBMNC cells suspension (0.2-0.3cc in boluses) are injected along the relevant axis below the knee, at intervals of 1-2 cm and to a mean depth of 1.5-2 cm, using a 21G needle. This procedure is repeated on each patient for three times, at intervals of 30-45 days from each other.
Foot-sparing surgery, the removal of all the unviable tissue and the reconstruction of the foot to allow a functional deambulation,is performed at the same time of the last implant in the patients with increased TcpO2 value above 30 mmHg. Between the implants, diabetologists together with nurses evaluated changing in pain, infection signs, wound size, demarcation of the necrosis, granulation tissue formation, perilesional tissue trophism and TcpO2 value to optimize standard of care. After the first treatment, a two years follow-up is registered, with evaluation at 1-3-6-12-18-24 months.
A baseline assessment is carried out, in order to estimate any differences among cases and controls before the treatment. Statistical evaluation includes non-parametric tests (Mann-Whitney U test for independent samples for continuous variables and Cochrane chi-square test for discrete variables), evaluation of Relative Risk (RR), Absolute Risk Reduction (ARR), Relative Risk Reduction (RRR) and Number Needed to Treat (NNT), multivariate survival analysis (Kaplan-Meier's survival analysis model).
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's enrollment of 76 is above the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Ospedale San Donato is the lead sponsor of 25 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in A-PBMNC therapy are treated with wound bed multiple perilesional and intramuscular injections of PBMNC cells suspension (0.2-0.3cc in boluses). This procedure is repeated on each patient for three times, at intervals of 30-45 days from each other.
Device: Pall Celeris System, point of care device for human cell therapy
Patients in No A-PBMNC therapy receive only supportive treatment including wound care and pain killer drug.
Concentration of PB-MNCs autologous cell therapy was produced by a filtration-based point-of-care device. All the procedures were performed in operatory room with anaesthesiologic support (propofol and/or peripheral block). Blood withdrawal (120 ml) was collected through a peripheral venous access. Blood was loaded, and gravity filtration was allowed to proceed until the upstream side of the filter had no remaining blood; filtration last about 10 minutes. During filtration, MNCs were captured in the filter while plasma, platelets (PLTs) and red blood cells (RBCs) were not retained. Immediately concentrate solution is injected in the perilesional area and intramuscular in the foot and the leg (0.2-0.3cc in boluses) below the knee, at intervals of 1-2 cm and to a mean depth of 1.5-2 cm, using a 21G needle. This procedure is repeated on each patient for three times, at intervals of 30-45 days from each other.
Amputation-free survival at 1 month
rate of non amputated limb 1 month after the intervention
Time frame: 1 month
Amputation-free survival at 3 months
rate of non amputated limb 3 months after the intervention
Time frame: 3 months
Amputation-free survival at 6 months
rate of non amputated limb 6 months after the intervention
Time frame: 6 months
Amputation-free survival at 12 months
rate of non amputated limb 12 months after the intervention
Time frame: 12 months
Amputation-free survival at 18 months
rate of non amputated limb 18 months after the intervention
Time frame: 18 months
Amputation-free survival at 24 months
rate of non amputated limb 24 months after the intervention
Time frame: 24 months
risk of death at 1 month
rate of dead subjects 1 month after the intervention
Time frame: 1 month
risk of death at 3 months
rate of dead subjects 3 months after the intervention
Time frame: 3 months
risk of death at 6 months
rate of dead subjects 6 months after the intervention
Time frame: 6 months
risk of death at 12 months
rate of dead subjects 12 months after the intervention
Time frame: 12 months
risk of death at 18 months
rate of dead subjects 18 months after the intervention
Time frame: 18 months
risk of death at 24 months
rate of dead subjects 24 months after the intervention
Time frame: 24 months
probability of healing at 1 month
rate of healed subjects 1 month after the intervention
Time frame: 1 month
probability of healing at 3 months
rate of healed subjects 3 months after the intervention
Time frame: 3 months
probability of healing at 6 months
rate of healed subjects 6 months after the intervention
Time frame: 6 months
probability of healing at 12 months
rate of healed subjects 12 months after the intervention
Time frame: 12 months
probability of healing at 18 months
rate of healed subjects 18 months after the intervention
Time frame: 18 months
probability of healing at 24 months
rate of healed subjects 24 months after the intervention
Time frame: 24 months
transcutaneous oxygen measurement (TcPO2) variation
comparison of TcPO2 at the second follow up (3 months after intervention) with the baseline measure
Time frame: 0-3 months
Healing time
time to reach complete epithelialization
Time frame: within 24 months
rest pain
comparison of rest pain measured by a numeric rating scale (NRS) min 0 - max 10, where 10 is the worst pain the patient has felt
Time frame: 0-1-3 months
No study locations are listed for this record.
Plan to share: No — data should not be shared before study completion and approvation by all the collaborators. Sharing data before this time would jeopardize the integrity of the clinical trial process and risk the scientific validity of the results.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ospedale San Donato