Autologous Bone Marrow Stem Cells in Pressure Ulcer Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Hospital Universitario Central de Asturias.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Hospital Universitario Central de Asturias
ClinicalTrials.gov Identifier:
NCT01572376
First received: March 28, 2012
Last updated: April 4, 2012
Last verified: April 2012
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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.

Resource links provided by NLM:


Further study details as provided by Hospital Universitario Central de Asturias:

Primary Outcome Measures:
  • Absence of adverse effects during timeframe as infections or complications related with the intervention. [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
    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:
  • Improvement and closure of the pressure ulcer [ Time Frame: One year ] [ Designated as safety issue: No ]
    The closure of the ulcer will be assessed by NMR and physical examination


Estimated Enrollment: 30
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01572376

Contacts
Contact: Jesús Otero, MD +34985108778 jesus.otero@sespa.princast.es

Locations
Spain
Hospital Universitario Central de Asturias Recruiting
Oviedo, Asturias, Spain, 33006
Contact: Jesus Otero, MD    +34985108778    jesus.otero@sespa.princast.es   
Principal Investigator: Jesus Otero, MD         
Sponsors and Collaborators
Hospital Universitario Central de Asturias
  More Information

No publications provided

Responsible Party: Hospital Universitario Central de Asturias
ClinicalTrials.gov Identifier: NCT01572376     History of Changes
Other Study ID Numbers: HUCentralAsturias
Study First Received: March 28, 2012
Last Updated: April 4, 2012
Health Authority: Spain: Spanish Agency of Medicines

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
Spinal Cord Injuries
Ulcer
Wounds and Injuries
Skin Ulcer
Skin Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Pathologic Processes

ClinicalTrials.gov processed this record on April 20, 2014