Autologous Bone Marrow Stem Cells in Pressure Ulcer Treatment
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Hospital Universitario Central de Asturias.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Hospital Universitario Central de Asturias
Information provided by (Responsible Party):
Hospital Universitario Central de Asturias
ClinicalTrials.gov Identifier:
NCT01572376
First received: March 28, 2012
Last updated: April 4, 2012
Last verified: April 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
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
| Estimated Enrollment: | 30 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2012 (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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01572376
Contacts
| Contact: Jesús Otero, MD | +34985108778 | jesus.otero@sespa.princast.es |
Locations
| Spain | |
| Hospital Universitario Central de Asturias | Recruiting |
| Oviedo, Asturias, Spain, 33006 | |
| Contact: Jesus Otero, MD +34985108778 jesus.otero@sespa.princast.es | |
| Principal Investigator: Jesus Otero, MD | |
Sponsors and Collaborators
Hospital Universitario Central de Asturias
More Information
No publications provided
| 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: | April 4, 2012 |
| 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:
|
Pressure Ulcer Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Skin Diseases |
Skin Ulcer Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on March 03, 2015