- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01903044
Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating
December 11, 2017 updated by: Alexandra Cristina Senegaglia, Pontifícia Universidade Católica do Paraná
Multicentric Study of the Autologous Bone Marrow-derived Mononuclear Cells Injection for Treatment of the Patients With Critical Lower Extremity Ischemia
The purpose of this study is to determine whether autologous bone marrow-derived stem cells are effective in the treatment of lower extremity ischemia.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
Critical limb ischemia (CLI) is a debilitating and disabling disease.
Symptoms include pain at rest, loss of tissue integrity, distal amputations and have a major impact on the quality of life.
Despite recent advances in surgical vascular procedures, a large number of patients (approximately 40%) are not eligible for these revascularization procedures.
New strategies for revascularization need to be explored.
Besides, in some cases results of such interventions do not give desirable effect, search of new methods of treatment therefore is necessary.
Recent evidence indicates that bone marrow-derived mononuclear cells (BM-MNC) are a potential new therapeutic target.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Paraná
-
Curitiba, Paraná, Brazil, 80215-901
- Pontifícia Universidade Católica do Paraná
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Critical lower limb ischemia, defined as ischemic pain at rest and / or the presence of minor tissue loss, with the possibility of healing.
- Failure of conventional medical treatment and attempts to open or percutaneous revascularization before, with an observation period of two months after the last attempt at revascularization.
- Patients considered at high risk for new revascularization procedure by at least two independent observers.
Exclusion Criteria:
- Expected life span less than six months
- Large tissue loss in the ischemic limb indicating the need for limb amputation in the short term.
- Evidence of osteomyelitis in the ischemic extremity.
- Current or previous history of neoplasia.
- Unstable angina, recent stroke or other medical condition that contraindicate anesthesia for bone marrow aspiration.
- Proliferative retinopathy.
- Debilitating disease with a life span less than one year.
- Myelofibrosis, myelodysplasia or other diseases that affect the bone marrow.
- Use of alcohol in excess of twice-daily doses or history of illicit drug use.
- Need for continuous high doses of drug therapy with steroids (more than 7.5 mg/day).
- Positivity for HIV or syphilis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: BM-MNC injection
Injection of autologous bone marrow-derived mononuclear cells
|
BM-MNC cells will be injected in aliquots of 1 ml at multiple regions of the leg muscles
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Wound healing (wound size, wound stage) - monitoring the healing of trophic lesions
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical outcome classification
Time Frame: 3 months, 6 months
|
Improvement of symptoms, functional capacity, exercises tolerance assessed by change in Rutherford scale of CLI
|
3 months, 6 months
|
Pain and analgesics use
Time Frame: 3 months
|
3 months
|
|
Quality of life outcome
Time Frame: 3 months, 6 months
|
3 months, 6 months
|
|
Improvement of the coronary and collateral circulation.
Time Frame: 3 months
|
3 months
|
|
Survival without amputation
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (ACTUAL)
March 1, 2017
Study Completion (ANTICIPATED)
September 1, 2018
Study Registration Dates
First Submitted
July 10, 2013
First Submitted That Met QC Criteria
July 16, 2013
First Posted (ESTIMATE)
July 19, 2013
Study Record Updates
Last Update Posted (ACTUAL)
December 13, 2017
Last Update Submitted That Met QC Criteria
December 11, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Necrosis
- Cardiovascular Diseases
- Skin Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Skin Ulcer
- Diabetes Complications
- Diabetes Mellitus
- Diabetic Neuropathies
- Atherosclerosis
- Foot Ulcer
- Diabetic Foot
- Vascular Diseases
- Ischemia
- Peripheral Arterial Disease
- Peripheral Vascular Diseases
- Leg Ulcer
- Gangrene
Other Study ID Numbers
- ICMI_ 404732/2012-7
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetic Foot
-
University of PadovaUnknownDiabetic Foot | Diabetic Foot Ulcer | Diabetic Foot Infection | Diabetic Foot Ulcer Neuropathic | Deformities FootItaly
-
Johns Hopkins UniversityWithdrawnDiabetic Foot | Diabetic Foot Ulcer | Diabetic Foot Infection | Diabetic Foot Ulcer Mixed | Vascular Ulcer (Arterial or Venous Including Diabetic Ulcers Not Located on the Foot)
-
Integra LifeSciences CorporationMayo Clinic; Temple University; Samuel Merritt University; New York College of... and other collaboratorsCompletedFoot Ulcers, DiabeticUnited States
-
Community Pharmacology Services LtdKeneric HealthcareNot yet recruitingDiabetic Foot Ulcer | Diabetic Foot Ulcer Neuropathic | Diabetic Foot Ulcer Ischemic
-
Exciton Technologies Inc.CompletedDiabetic Foot Ulcer | Diabetic Foot Infection | Non-healing Diabetic Foot UlcerCanada
-
Corporacion Parc TauliCompletedDiabetic Foot Ulcer | Diabetic Foot Ulcer NeuropathicPakistan
-
University of the PunjabHigher Education Commission (Pakistan); Centre of Excellence in Molecular Biology... and other collaboratorsRecruitingDiabetes Mellitus | Diabetic Foot | Foot Ulcer | Diabetes Complications | Diabetic Foot Ulcer | Diabetic Foot Infection | Diabetic Foot Ulcer Neuropathic | Foot Ulcer Due to Type 1 Diabetes Mellitus | Foot Ulcer Due to Type 2 Diabetes Mellitus | Chronic Diabetic Ulcer of Left Foot | Chronic Diabetic Foot...Pakistan
-
University of MinnesotaRecruitingDiabetes Mellitus | Foot Ulcer | Ulcer | Diabetic Foot Ulcer | Foot Ulcer, Diabetic | Ulcer Foot | Ulcer, Leg | Ankle UlcerUnited States
-
HealthpointCompletedDiabetic Foot Ulcers | Diabetic Foot WoundsUnited States, Canada
-
HealthpointCompleted
Clinical Trials on BM-MNC injection
-
National University of MalaysiaCytopeutics Sdn. Bhd.UnknownCritical Limb IschemiaMalaysia
-
Royan InstituteTehran University of Medical SciencesCompletedIschemia | Peripheral Vascular DiseasesIran, Islamic Republic of
-
Royan InstituteShiraz University of Medical Sciences; Small Business Developing CenterCompletedStem Cell Transplantation | CirrhosisIran, Islamic Republic of
-
Van Hanh General HospitalUnknownType 2 Diabetes MellitusVietnam
-
Fuzhou General HospitalCompletedType 2 Diabetes MellitusChina
-
University of FlorenceTuscany RegionCompletedCritical Limb IschemiaItaly
-
Royan InstituteCompletedMyocardial InfarctionIran, Islamic Republic of
-
Royan InstituteCompletedMyocardial InfarctionIran, Islamic Republic of
-
Mayo ClinicRecruitingFacet-Mediated Low Back PainUnited States