Clinical Efficacy of Platelet Gel From Cord Blood for the Treatment of Diabetic Foot Ulcers

Summary

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.

Conditions

• Diabetic Foot Ulcers

Interventions

BIOLOGICAL

Allogeneic cord blood platelet gel-CBPG

For the medication of patients, one CBPG unit (mean volume 10 mL, range 5-15; mean platelet concentration 1 x 109/L, range 0.8 - 1.2 x 109/L. 10 mL in plasma) will be administered every 3-4 days. CBPG units, cryopreserved and stored in a plastic bag in a -80°C freezer, will be thawed at 37°C in a waterbath and activated with Calcium gluconate and immediately transported to sites of clinical use and applied to the skin ulcer without breaking the sterility chain.

OTHER

Standard Local Medications-SLM

Each clinical center will use their validated standard local medications. Details and specifications of the local standard medication procedures will be collected from each participating centre.

Sponsors & Collaborators

• Italian National Cord Blood Network

  collaborator OTHER

• Centro Nazionale Sangue

  lead OTHER_GOV

Principal Investigators

• Maurizio Marconi, MD · Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

• Simonetta Pupella, MD · Centro Nazionale Sangue

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-31

Primary Completion

2017-02-28

Completion

2017-02-28

Countries

• Italy
• Spain

Study Locations