Ignite Creation Date:
2025-12-24 @ 7:01 PM
Ignite Modification Date:
2026-02-17 @ 8:10 PM
Study NCT ID:
NCT02152657
Status:
COMPLETED
Last Update Posted:
2017-04-26
First Post:
2014-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Autologous Mesenchymal Stem Cell Transplantation in Chronic Spinal Cord Injury: a Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045164', 'term': 'Mesenchymal Stem Cell Transplantation'}], 'ancestors': [{'id': 'D033581', 'term': 'Stem Cell Transplantation'}, {'id': 'D017690', 'term': 'Cell Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Tomography-guided mesenchymal stem cells injection.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-25', 'studyFirstSubmitDate': '2014-05-20', 'studyFirstSubmitQcDate': '2014-05-28', 'lastUpdatePostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Magnetic resonance imaging', 'timeFrame': 'Six months', 'description': 'After the transplantation of the cells, patients will be followed up by clinical examinations and will perform laboratorial and radiological exams, in order to search for complications of the procedure.'}], 'secondaryOutcomes': [{'measure': 'Sensitivity and motor strength on the inferior limbs', 'timeFrame': 'Six months', 'description': 'AIS (ASIA Improvement Scale) degree on the ASIA score will be assessed in order to evaluate sensitivity and motor strength on the inferior limbs.'}, {'measure': 'Improvement in urological function', 'timeFrame': 'Six months', 'description': 'The patients will undergo urodynamic study to evaluate urological improvements.'}, {'measure': 'Improvements in sensorial mapping and neuropathic pain', 'timeFrame': 'Six months', 'description': 'The patients will be submitted to specific questionnaires and clinical examinations in order to evaluate improvements in sensorial mapping and neuropathic pain.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Spinal cord injury', 'Stem cell transplantation', 'Mesenchymal stem cell'], 'conditions': ['Spinal Cord Injury']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to analyze the safety and efficacy of mesenchymal stem cell transplantation through percutaneous injection in patients with chronic spinal cord injury.', 'detailedDescription': "This is a pilot, open, phase I study, in a prospective cohort. The study population will consist of 5 patients who had spinal cord injury for at least 6 months, with complete paraplegia.\n\nA practitioner, a neurosurgeon and a nurse will review the medical records of patients to determine the presence / absence of inclusion / exclusion criteria. If the patient is a potential candidate for the study, an interview will be scheduled with the patient to review and confirm his/her eligibility. If the clinical eligibility is confirmed, the patient will undergo psychosocial evaluation to determine the degree of emotional equilibrium and conditions for participation in the study.\n\nPatients will undergo a series of clinical and neurological evaluations and will also be submitted to the following procedures:\n\n* Cell blood count;\n* Biochemical analysis (measurement of electrolytes - sodium, potassium, magnesium);\n* Renal function tests (urea and creatinine);\n* Liver function tests;\n* Coagulation profile;\n* Metabolic profile (glucose, total cholesterol and fractions);\n* Urine summary and culture;\n* Serology required for blood transfusion and marrow transplant in Brasil;\n* Electrocardiogram;\n* Chest X-Ray, X-ray of knees;\n* Bone densitometry;\n* Urodynamic studies;\n* Somatosensory evoked potential;\n* Computed tomography of thoracic and lumbar spine;\n* MRI of the thoracic and lumbar spine.\n\nAlso as part of the preoperative evaluation, the patients will respond to questions from the SF (Short Form) -36 questionnaire (for assessment of quality of life) and the questionnaires for the assessment of neuropathic pain.\n\nClinical follow-up will be kept for patients who suspend their participation in the study for any adverse event and / or laboratory abnormality, or for the patient's own desire, following insurance protocols. In addition to the clinical and surgical follow-up, specific medical care will be offered to patients who experience adverse events, until stabilization of the patient, even if the target date for completion of the study has been exceeded.\n\nThe candidates included in the study will be asked to voluntarily participate and give their informed written consent. Patients will be recruited for a minimum period of 06 months to follow up with additional laboratory and clinical examinations."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Closed spinal cord injury at thoracic or thoracolumbar level bellow T8, or open spinal cord injury, at the same level, provided that the mechanism of the lesion is a spinal shock, ischemia or hematoma\n* ASIA class A\n* Signing the written consent\n\nExclusion Criteria:\n\n* Anatomical transection of the spinal cord\n* Spinal cord lesion by sharp objects\n* Ongoing infections\n* Terminal, neurodegenerative or primary hematological diseases\n* Osteopathies which determine a higher risc to the bone marrow puncture\n* Coagulopathies\n* Severe hepatic, renal or heart failure\n* Pregnancy or lactation\n* Clinical conditions that hinder the percutaneous injection of the cells such as arthrodesis\n* Use of metallic implants near vascular structures (such as cardiac pacemaker or aortic prosthesis) which won't allow patients to perform MRI\n* Participation in other clinical trial"}, 'identificationModule': {'nctId': 'NCT02152657', 'briefTitle': 'Evaluation of Autologous Mesenchymal Stem Cell Transplantation in Chronic Spinal Cord Injury: a Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Sao Rafael'}, 'orgStudyIdInfo': {'id': 'SCI-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mesenchymal stem cell transplantation', 'interventionNames': ['Other: Mesenchymal stem cell transplantation']}], 'interventions': [{'name': 'Mesenchymal stem cell transplantation', 'type': 'OTHER', 'description': 'Mesenchymal stem cell transplantation through percutaneous injection.', 'armGroupLabels': ['Mesenchymal stem cell transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41253-190', 'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Hospital São Rafael', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}], 'overallOfficials': [{'name': 'Ricardo R dos Santos, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital São Rafael'}, {'name': 'Milena BP Soares, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital São Rafael'}, {'name': 'Bruno SF Souza, MD, Msc', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital São Rafael'}, {'name': 'Ticiana F Larocca, MD, Msc', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital São Rafael'}, {'name': 'Rodrigo L Alves, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital São Rafael'}, {'name': 'Yuri MA Souza, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital São Rafael'}, {'name': 'André C Matos, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital São Rafael'}, {'name': 'Cristiane F Villarreal, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital São Rafael'}, {'name': 'Alexandre S Carvalho-da-Silva, Student', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital São Rafael'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Sao Rafael', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Ricardo Ribeiro dos Santos', 'investigatorAffiliation': 'Hospital Sao Rafael'}}}}