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Autologous Bone Marrow Stem Cells in Pressure Ulcer Treatment

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ClinicalTrials.gov Identifier: NCT01572376
Recruitment Status : Completed
First Posted : April 6, 2012
Last Update Posted : August 25, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Type IV Pressure Ulcers Chronic Wounds Spinal Cord Injury Procedure: Infusion of autologous bone marrow stem cells after wound debridement. Phase 1 Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Pressure Ulcers With Autologous Bone Marrow Stem Cells in Spinal Cord Injury Patients.Phase I/II Study.
Study Start Date : November 2007
Primary Completion Date : December 2008
Study Completion Date : December 2010

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Bone marrow stem cells
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.
Cleaning of the wound with heparinized saline, cell infusion and closing with suture.


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01572376


Locations
Spain
Hospital Universitario Central de Asturias
Oviedo, Asturias, Spain, 33006
Sponsors and Collaborators
Hospital Universitario Central de Asturias
More Information

Publications:
Responsible Party: Hospital Universitario Central de Asturias
ClinicalTrials.gov Identifier: NCT01572376     History of Changes
Other Study ID Numbers: HUCentralAsturias
First Posted: April 6, 2012    Key Record Dates
Last Update Posted: August 25, 2015
Last Verified: August 2015

Keywords provided by Hospital Universitario Central de Asturias:
Pressure ulcers
Chronic wounds
Spinal cord injury patients
Bone marrow
Mononuclear
Debridement

Additional relevant MeSH terms:
Pressure Ulcer
Ulcer
Spinal Cord Injuries
Pathologic Processes
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Skin Ulcer
Skin Diseases