Gabriela Otero1, Caroline Agorio1, Alexandra Sujanov2, Lourdes Echarte2, Ana Tchekmedyian3, Monica Montelongo4, Alba Menyou4, Andres Rodriguez4, Lilian Diaz5, Ismael Rodriguez4, Cristina Touriño6. 1. Dermatology Department, Hospital de Clínicas Dr Manuel Quintela, Faculty of Medicine, Universidad de la República, Uruguay. 2. Cell Therapy and Regenerative Medicine Unit, Hospital de Clínicas Dr Manuel Quintela, Faculty of Medicine, Universidad de la República, Uruguay. 3. Centro de Tratamiento de Enfermedades de la Piel (CETEP), Centro Hospitalario Pereira Rossell, Uruguay. 4. Transfusion Medicine Department, Hospital de Clínicas Dr Manuel Quintela, Faculty of Medicine, Universidad de la República, Uruguay. 5. Hematology Department, Hospital de Clínicas Dr Manuel Quintela, Faculty of Medicine, Universidad de la República, Uruguay. 6. Cell Therapy and Regenerative Medicine Unit Medicine Department, Hospital de Clínicas Dr Manuel Quintela, Faculty of Medicine, Universidad de la República, Uruguay. Electronic address: cltourino@gmail.com.
Abstract
BACKGROUND: Chronic venous leg ulcers (VLUs) are a common problem in clinical practice and available treatments are not satisfactory. The use of adjuvant therapies in combination with lower limb compression may lead to improved healing rates. Chronic wounds are candidates for new strategies in the emergent field of regenerative medicine. Bone marrow-derived cells (BMDCs) contain cells and secrete cytokines known to participate in wound healing. Thus, BMDC therapy seems a logical strategy for the treatment of chronic wounds. Our objective was to evaluate feasibility, safety and initial clinical outcome of autologous BMDC therapy associated with standard treatment in patients with VLUs. METHODS: We conducted an open-label, single-arm, prospective pilot clinical trial in four patients with six chronic VLUs. The study protocol was approved by the institutional and national review boards and ethics committees. Bone marrow was harvest, processed and then administered by multiple injections into the ulcers. All patients received standard treatment and non-healing characteristics of the VLUs were confirmed at study entry. RESULTS: Ulcer size and wound pain evaluated 12 months after BMDC treatment were significantly reduced (P < 0.05). BMDC treatment was safe and well tolerated in long-term follow-up. DISCUSSION: Despite the low number of patients studied, our results showed that autologous BMDC treatment could be a useful, feasible and safe procedure to enhance ulcer healing. However, randomized controlled trials with more patients are needed to address this question and translate this approach into clinical practice.
BACKGROUND:Chronic venous leg ulcers (VLUs) are a common problem in clinical practice and available treatments are not satisfactory. The use of adjuvant therapies in combination with lower limb compression may lead to improved healing rates. Chronic wounds are candidates for new strategies in the emergent field of regenerative medicine. Bone marrow-derived cells (BMDCs) contain cells and secrete cytokines known to participate in wound healing. Thus, BMDC therapy seems a logical strategy for the treatment of chronic wounds. Our objective was to evaluate feasibility, safety and initial clinical outcome of autologous BMDC therapy associated with standard treatment in patients with VLUs. METHODS: We conducted an open-label, single-arm, prospective pilot clinical trial in four patients with six chronic VLUs. The study protocol was approved by the institutional and national review boards and ethics committees. Bone marrow was harvest, processed and then administered by multiple injections into the ulcers. All patients received standard treatment and non-healing characteristics of the VLUs were confirmed at study entry. RESULTS:Ulcer size and wound pain evaluated 12 months after BMDC treatment were significantly reduced (P < 0.05). BMDC treatment was safe and well tolerated in long-term follow-up. DISCUSSION: Despite the low number of patients studied, our results showed that autologous BMDC treatment could be a useful, feasible and safe procedure to enhance ulcer healing. However, randomized controlled trials with more patients are needed to address this question and translate this approach into clinical practice.