Autologous Bone Marrow Stem Cells in Pressure Ulcer Treatment

Hospital Universitario Central de Asturias

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Wounds; Spinal Cord Injury; Type IV Pressure Ulcers

Treatments: Procedure: Infusion of autologous bone marrow stem cells after wound debridement.

Study type: Interventional

Funder types: Other

Identifiers

NCT01572376

HUCentralAsturias

Details and patient eligibility

About

The aim of the study is to determine the safety and feasibility of an autologous mononuclear stem cells infusion in pressure ulcers of paraplegic patients; and moreover, to evaluate the efficacy of the treatment.

Full description

Taking into account the encouraging results obtained in the treatment of non-healing chronic wounds using bone marrow cells Given that treatment strategies for pressure ulcers can be both costly and complex, in this study we examine the possibility of improving pressure ulcer healing using stem cell therapy.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type IV ulcer pressures of more than 4 months topical treatment without response
• No option for conventional surgery
• Age range of 18-75 years old

Exclusion criteria

• Patients out of inclusion age range
• Patients with evidences of mental illness
• Patients with evidences of previous alcohol or drugs dependencies
• Pregnant women
• Patients with present or previous malignant disease during the last 5 years, except for basal cell carcinoma

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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30 participants in 1 patient group

Bone marrow stem cells

Experimental group

Description:

Bone marrow was obtained by posterosuperior iliac crest aspiration under topical anesthesia. Mononuclear cells were isolated by Ficoll density gradient and will be resuspended in heparinized isotonic saline for infusion into the wound.

Treatment:

Procedure: Infusion of autologous bone marrow stem cells after wound debridement.