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Clinical Efficacy of Platelet Gel From Cord Blood for the Treatment of Diabetic Foot Ulcers (CBPG-DFU)
A novel method (PCT n. WO 2010/007502 A2, 2010) has been developed to obtain platelet gel from umbilical cord blood (CBPG). The main advantages so far identified in CBPG as compared to platelet gel derived from adult platelets relate to the lack of microbiological contamination in the former and to a different profile of growth factors concentrations, such as a higher content of VEGF and lower content of TGF in CBPG. Recent developments have led to a procedure in which CBPG can be prepared, stored in a cryopreservation bag and applied to the skin ulcer without breaking the sterility chain. In spite of promising results on allogeneic CBPG, a randomized clinical trial of sufficient statistical power to detect significant advantages (clinical and economical) will be performed in patients affected by diabetic foot ulcers and randomly treated with CBPG versus standard local medications (SLM).This study is a multicenter (8 centers) controlled randomized clinical trial. Outcomes: (1) primary objective is to evaluate the number of closed skin ulcers within 4 weeks of treatment with CBPG vs standard local medications; (2) secondary objectives are percent skin ulcer closure area, number and type of adverse events and cost of treatment. Sample size calculation: 95 + 5 (dropout) test and 95 + 5 (dropout) control patients ensure 80% power to detect as statistically significant (p\<0.05) \>60% healing in test vs 40% healing in control.Each clinical centre has been invited to enrol 15 treated and 15 control patients, according to local availability in 12 months. CB units are routinely collected after mother's informed consent before and after placenta delivery in accredited public cord blood banks belonging to the Italian Cord Blood Network (ITCBN) coordinated by the Centro Nazionale Sangue (CNS). After storage and transportation at monitored room temperature, the units will be processed for the preparation of CBPG within 48 hours of collection. CBPG will be prepared according to standard procedures with a defined final platelet concentration (0.8-1.2 x 109/L). The CBPC units will be finally cryopreserved in a -80°C freezer in view of the clinical use of the CBPG, which will require thawing at 37°C in a waterbath and activation with Calcium gluconate. For SLM, each clinical center will use their validated standard procedures.
Details
| Lead sponsor | Centro Nazionale Sangue |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 50 |
| Start date | 2015-01 |
| Completion | 2017-02 |
Conditions
- Diabetic Foot Ulcers
Interventions
- Allogeneic cord blood platelet gel-CBPG
- Standard Local Medications-SLM
Primary outcomes
- Number of closed skin ulcers within 4 weeks of treatment with cord blood platelet gel (CBPG) vs standard local medications — 4 weeks
The major end-point will be to test feasibility and compare efficacy of treating diabetic foot skin ulcers (Texas C I-II) with allogeneic CBPG versus SLM and their respective costs. The primary outcome measures will be: number of healed wounds after 4 weeks of CBPG treatment versus control and time to achieve complete closure. Lesions will be assessed two times per week. Wounds with less than 50% closure after 4 weeks will be considered as a failure. The main target will be to validate the clinical use of an allogeneic product matching several requirements: to comply with routine process of periodic blood collection and blood component preparation; to maintain closed and aseptic conditions through the entire process; to contain platelet growth factor concentrations reported to be clinically effective; to be suitable to treat one medium-size ulcer per aliquot, defined as 'CBPG unit' (on average 10 mL of CB plasma containing 10 billion platelets); to be ABO compatible with the patient.
Countries
Italy, Spain