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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):
Hospital Universitario Central de Asturias

Tracking Information
First Submitted Date  ICMJE March 28, 2012
First Posted Date  ICMJE April 6, 2012
Last Update Posted Date August 25, 2015
Study Start Date  ICMJE November 2007
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01572376 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2012)
Improvement and closure of the pressure ulcer [ Time Frame: One year ]
The closure of the ulcer will be assessed by NMR and physical examination
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Bone Marrow Stem Cells in Pressure Ulcer Treatment
Official Title  ICMJE Treatment of Pressure Ulcers With Autologous Bone Marrow Stem Cells in Spinal Cord Injury Patients.Phase I/II Study.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Type IV Pressure Ulcers
  • Chronic Wounds
  • Spinal Cord Injury
Intervention  ICMJE Procedure: Infusion of autologous bone marrow stem cells after wound debridement.
Cleaning of the wound with heparinized saline, cell infusion and closing with suture.
Study Arms  ICMJE 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.
Intervention: Procedure: Infusion of autologous bone marrow stem cells after wound debridement.
Publications * Sarasúa JG, López SP, Viejo MA, Basterrechea MP, Rodríguez AF, Gutiérrez AF, Gala JG, Menéndez YM, Augusto DE, Arias AP, Hernández JO. Treatment of pressure ulcers with autologous bone marrow nuclear cells in patients with spinal cord injury. J Spinal Cord Med. 2011;34(3):301-7. doi: 10.1179/2045772311Y.0000000010.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 4, 2012)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01572376
Other Study ID Numbers  ICMJE HUCentralAsturias
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospital Universitario Central de Asturias
Study Sponsor  ICMJE Hospital Universitario Central de Asturias
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospital Universitario Central de Asturias
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP