Chronic Wounds, Spinal Cord Injury, Type IV Pressure Ulcers
Conditions
Keywords
Pressure ulcers, Chronic wounds, Spinal cord injury patients, Bone marrow, Mononuclear, Debridement
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.
Interventions
PROCEDUREInfusion of autologous bone marrow stem cells after wound debridement.
Cleaning of the wound with heparinized saline, cell infusion and closing with suture.
Sponsors
Hospital Universitario Central de Asturias
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Improvement and closure of the pressure ulcer | One year | The closure of the ulcer will be assessed by NMR and physical examination |
Countries
Spain
Outcome results
None listed