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Autologous Mesenchymal Stem Cells Transplantation in Cervical Chronic and Complete Spinal Cord Injury

NCT ID: NCT02574572

Last Updated: 2017-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-06

Study Completion Date

2020-06-30

Brief Summary

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The purpose of this study is to analyze the safety and efficacy of autologous bone marrow mesenchymal stem cell transplantation in patients with cervical chronic and complete spinal cord injury.

Detailed Description

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This is a pilot, phase I study, in a prospective cohort. The study population will consist of 10 patients who had spinal cord injury for at least 12 months, with cervical chronic and complete spinal cord injury, ASIA grade A.

A practitioner, a surgeon and a nurse will review the medical records of the 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 to review and confirm his/her eligibility.

Patients will undergo a series of clinical and neurological assessments and will also be submitted to the following procedures:

* Cell blood count;
* Biochemical analysis (measurement of electrolytes - sodium, potassium, magnesium);
* Renal function tests (urea and creatinine);
* Liver function tests;
* Coagulation profile;
* Metabolic profile (glucose, total cholesterol and fractions);
* Urine summary and culture;
* Serology required for blood transfusion and marrow transplant in Brazil;
* Electrocardiogram;
* Chest X-Ray;
* Bone densitometry;
* Urodynamic studies;
* Somatosensory evoked potential;
* Computed tomography of thoracic and lumbar spine;
* Magnetic resonance imaging of the thoracic and lumbar spine.

Also 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.

Clinical 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.

The candidates included in the study will be asked to voluntarily participate and give their informed written consent.

Conditions

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Spinal Cord Injury

Keywords

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Spinal cord injury Mesenchymal cells Stem cells

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single group

Patients with spinal cord injury that will undergo laminectomy and autologous mesenchymal cells intralesional injection

Group Type EXPERIMENTAL

Autologous mesenchymal cells transplantation

Intervention Type BIOLOGICAL

All patients will undergo laminectomy and autologous mesenchymal cells injection into the lesion area.

Interventions

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Autologous mesenchymal cells transplantation

All patients will undergo laminectomy and autologous mesenchymal cells injection into the lesion area.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Blunt spinal cord injury at cervical level, between C5 and C7, or penetrating spinal cord injury, at the same level, provided that the mechanism of injury had been spinal shock, ischemia or hematoma, with at least 12 months of injury;
* ASIA grade A;
* Signing of the written consent.

Exclusion Criteria

* Spinal cord injuries by sharp objects, firearms, and not traumatic or congenital causes, even if at different levels of the spinal cord;
* Concomitant brain injuries;
* Diabetes mellitus type 1 or 2 as defined by fasting glucose above 126 mg / use of medication and medical history;
* Infectious processes in acute and / or chronic course, confirmed by additional tests and / or medical history;
* Immunodeficiency, autoimmune diseases and neoplastic processes, confirmed by additional tests and / or medical history;
* Terminal, neurodegenerative, primary hematologic and musculoskeletal diseases confirmed by additional tests and / or past medical history;
* Osteopathies reflecting increased risk for bone marrow puncture;
* Coagulopathies;
* Severe organ failure (heart, kidney or liver), confirmed by additional tests or medical history;
* Pregnancy or lactation;
* Clinical complications that hinder or contraindicate the surgical procedure;
* Use of metallic implants near vascular structures (such as cardiac pacemaker), or other contraindication to magnetic resonance imaging;
* Psychiatric disorders, psychosocial and cognitive impairment confirmed by medical evaluation;
* Abusive use of alcohol and / or illegal substances use;
* Participation in other clinical trial.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Sao Rafael

OTHER

Sponsor Role lead

Responsible Party

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Ricardo Ribeiro dos Santos

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ricardo Ribeiro-dos-Santos, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital São Rafael

Milena BP Soares, PhD

Role: STUDY_DIRECTOR

Hospital São Rafael

Bruno SF de Souza, MD, Msc

Role: STUDY_CHAIR

Hospital São Rafael

Ticiana F Larocca, MD, Msc

Role: STUDY_CHAIR

Hospital São Rafael

Rodrigo L Alves, MD, PhD

Role: STUDY_CHAIR

Hospital São Rafael

Carolina T Macedo, MD, MSc

Role: STUDY_CHAIR

Hospital São Rafael

André C Matos, MD

Role: STUDY_CHAIR

Hospital São Rafael

Cristiane F Villarreal, PhD

Role: STUDY_CHAIR

Fundação Oswaldo Cruz

Antônio Olímpio S Moura, MD

Role: STUDY_CHAIR

Hospital São Rafael

Eduardo Brazão, MD

Role: STUDY_CHAIR

Hospital São Rafael

Kátia N Silva, MSc

Role: STUDY_CHAIR

Hospital São Rafael

Daniela N Silva, MSc

Role: STUDY_CHAIR

Hospital São Rafael

Clarissa LM de Souza, MD

Role: STUDY_CHAIR

Hospital São Rafael

Locations

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Hospital São Rafael

Salvador, Estado de Bahia, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Ricardo Ribeiro-dos-Santos, PhD

Role: CONTACT

Phone: 557132816489

Email: [email protected]

Facility Contacts

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Ticiana F Larocca, MD, MSc

Role: primary

Carolina T Macedo, MD, MSc

Role: backup

References

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Macedo CT, de Freitas Souza BS, Villarreal CF, Silva DN, da Silva KN, de Souza CLEM, da Silva Paixao D, da Rocha Bezerra M, da Silva Moura Costa AO, Brazao ES, Marins Filho JP, Matos AC, Dos Santos RR, Soares MBP. Transplantation of autologous mesenchymal stromal cells in complete cervical spinal cord injury: a pilot study. Front Med (Lausanne). 2024 Sep 12;11:1451297. doi: 10.3389/fmed.2024.1451297. eCollection 2024.

Reference Type DERIVED
PMID: 39328312 (View on PubMed)

Other Identifiers

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SCI-003

Identifier Type: -

Identifier Source: org_study_id