Autologous Bone Marrow Stem Cells in Pressure Ulcer Treatment

Spinal Cord Injury Clinical Trial

Official title:

Treatment of Pressure Ulcers With Autologous Bone Marrow Stem Cells in Spinal Cord Injury Patients.Phase I/II Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01572376
• Other study ID #: HUCentralAsturias
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 28, 2012
• Last updated: August 24, 2015
• Start date: November 2007
• Est. completion date: December 2010

Study information

• Verified date: August 2015
• Source: Hospital Universitario Central de Asturias
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2010
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Wounds
• Pressure Ulcer
• Spinal Cord Injuries
• Spinal Cord Injury
• Type IV Pressure Ulcers
• Ulcer

Intervention

Procedure:
• Infusion of autologous bone marrow stem cells after wound debridement.
Cleaning of the wound with heparinized saline, cell infusion and closing with suture.

Locations

Country	Name	City	State
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Central de Asturias

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Improvement and closure of the pressure ulcer	The closure of the ulcer will be assessed by NMR and physical examination	One year	No