Autologous Bone Marrow Stem Cells in Pressure Ulcer Treatment - Full Text View

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:

MedlinePlus related topics: Pressure Sores Spinal Cord Injuries Wounds and Injuries

U.S. FDA Resources

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


Enrollment:	30
Study Start Date:	November 2007
Study Completion Date:	December 2010
Primary Completion Date:	December 2008 (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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01572376

Locations


Spain
Hospital Universitario Central de Asturias
Oviedo, Asturias, Spain, 33006

Sponsors and Collaborators

Hospital Universitario Central de Asturias

More Information

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.


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:	August 24, 2015
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:


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

ClinicalTrials.gov processed this record on September 30, 2016