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NCT Number: NCT01572376

Autologous Bone Marrow Stem Cells in Pressure Ulcer Treatment

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.

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Key information

Conditions

Type IV Pressure Ulcers Central Nervous System Diseases Chronic Wounds Nervous System Diseases Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injury Trauma, Nervous System Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33006, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Infusion of autologous bone marrow stem cells after wound debridement.

Procedure

Cleaning of the wound with heparinized saline, cell infusion and closing with suture.

Primary outcomes

  1. Absence of adverse effects during timeframe as infections or complications related with the intervention.

    Time frame: 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 outcomes

  1. Improvement and closure of the pressure ulcer

    Time frame: One year

    The closure of the ulcer will be assessed by NMR and physical examination

Sponsors and collaborators

Lead sponsor

Hospital Universitario Central de Asturias

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2010
First posted
Apr 6, 2012
Registry last updated
Aug 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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