Autologous Bone Marrow Stem Cells in Pressure Ulcer Treatment

NCT01572376 | Completed Phase 1

• 1 other identifier: HUCentralAsturias
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Type IV Pressure Ulcers; Chronic Wounds; Spinal Cord Injury

Keywords

Pressure ulcers; Chronic wounds; Spinal cord injury patients; Bone marrow; Mononuclear; Debridement

Outcome Measures

Primary Outcomes (1)

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

  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

  Six months

Secondary Outcomes (1)

• Improvement and closure of the pressure ulcer

  One year

Study Arms (1)

Bone marrow stem cells

EXPERIMENTAL

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.

Interventions

Infusion of autologous bone marrow stem cells after wound debridement. PROCEDURE

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

Bone marrow stem cells

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario Central de Asturias: lead

Study Sites (1)

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33006, Spain

Location

Related Publications (1)

• Sarasua JG, Lopez SP, Viejo MA, Basterrechea MP, Rodriguez AF, Gutierrez AF, Gala JG, Menendez YM, Augusto DE, Arias AP, Hernandez 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.

  PMID: 21756569 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Pressure Ulcer

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2012
• First Posted: April 6, 2012
• Study Start: November 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2010
• Last Updated: August 25, 2015

Record last verified: 2015-08

Locations

ES (1)