Autologous Bone Marrow Stem Cells in Pressure Ulcer Treatment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treatment of Pressure Ulcers With Autologous Bone Marrow Stem Cells in Spinal Cord Injury Patients.Phase I/II Study.

Conditions
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Type IV Pressure Ulcers, Chronic Wounds, Spinal Cord Injury

Intervention / Treatment
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* Procedure: Infusion of autologous bone marrow stem cells after wound debridement.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bone marrow stem cells<br>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. | Procedure: Infusion of autologous bone marrow stem cells after wound debridement.<br>* Cleaning of the wound with heparinized saline, cell infusion and closing with suture.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of adverse effects during timeframe as infections or complications related with the intervention. | 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 | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement and closure of the pressure ulcer | The closure of the ulcer will be assessed by NMR and physical examination | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pressure ulcers, Chronic wounds, Spinal cord injury patients, Bone marrow, Mononuclear, Debridement