Autologous Bone Marrow Stem Cells in Pressure Ulcer Treatment
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ClinicalTrials.gov Identifier: NCT01572376 |
Recruitment Status
:
Completed
First Posted
: April 6, 2012
Last Update Posted
: August 25, 2015
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Condition or disease | Intervention/treatment | Phase |
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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 (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Single (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. |
Study Start Date : | November 2007 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | December 2010 |
Arm | Intervention/treatment |
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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.
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Procedure: Infusion of autologous bone marrow stem cells after wound debridement.
Cleaning of the wound with heparinized saline, cell infusion and closing with suture.
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- Absence of adverse effects during timeframe as infections or complications related with the intervention. [ Time Frame: Six months ]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
- Improvement and closure of the pressure ulcer [ Time Frame: One year ]The closure of the ulcer will be assessed by NMR and physical examination

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01572376
Spain | |
Hospital Universitario Central de Asturias | |
Oviedo, Asturias, Spain, 33006 |
Publications:
Responsible Party: | Hospital Universitario Central de Asturias |
ClinicalTrials.gov Identifier: | NCT01572376 History of Changes |
Other Study ID Numbers: |
HUCentralAsturias |
First Posted: | April 6, 2012 Key Record Dates |
Last Update Posted: | August 25, 2015 |
Last Verified: | August 2015 |
Keywords provided by Hospital Universitario Central de Asturias:
Pressure ulcers Chronic wounds Spinal cord injury patients |
Bone marrow Mononuclear Debridement |
Additional relevant MeSH terms:
Ulcer Spinal Cord Injuries Pressure Ulcer Pathologic Processes Spinal Cord Diseases Central Nervous System Diseases |
Nervous System Diseases Trauma, Nervous System Wounds and Injuries Skin Ulcer Skin Diseases |