Autologous Bone Marrow Stem Cells in Pressure Ulcer Treatment

NCT ID: NCT01572376

Last Updated: 2015-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2010-12-31

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.

Conditions

Type IV Pressure Ulcers; Chronic Wounds; Spinal Cord Injury

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Infusion of autologous bone marrow stem cells after wound debridement.

Intervention Type: PROCEDURE

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

Interventions

Infusion of autologous bone marrow stem cells after wound debridement.

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

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario Central de Asturias

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 21756569 (View on PubMed)

Other Identifiers

HUCentralAsturias

Identifier Type: -

Identifier Source: org_study_id