Autologous Bone Marrow Stem Cells in Pressure Ulcer Treatment

Phase 1

Completed

• Conditions: Chronic Wounds; Spinal Cord Injury; Type IV Pressure Ulcers
• Interventions: Procedure: Infusion of autologous bone marrow stem cells after wound debridement.

• Registration Number: NCT01572376
• Lead Sponsor: Hospital Universitario Central de Asturias

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2008-12
• Study Completion: 2010-12
• Study First Submitted: 2012-03-28
• Study First Submitted QC: 2012-04-04
• Study First Posted: 2012-04-06
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-24
• Last Update Posted: 2015-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bone marrow stem cells	Infusion of autologous bone marrow stem cells after wound debridement.	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.

Primary Outcome Measures

Name	Time	Method
Absence of adverse effects during timeframe as infections or complications related with the intervention.	Six months	The proposed trial will involve the recruitment of a total of 30 patients. The cells will be collected via bone marrow sampling. The aspirate will centrifuged on a Ficoll density gradient to isolate mononuclear cells, wich will be resuspended in heparinized isotonic saline for infusion into the area of the wound. Assessment of adverse events will be by wound examination and laboratory (microbiological)parameters

Secondary Outcome Measures

Name	Time	Method
Improvement and closure of the pressure ulcer	One year	The closure of the ulcer will be assessed by NMR and physical examination

Trial Locations

Locations (1)

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain