Safety Study of Local Administration of Autologous Bone Marrow Stromal Cells in Chronic Paraplegia (CME-LEM1)

Majadahonda Iron Gate University

Status and phase: Completed; Phase 1

Conditions: Spinal Cord Injury

Treatments: Biological: Mesenchymal stromal cell therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01909154

2010-023285-46 (EudraCT Number)

CME-LEM1

Details and patient eligibility

About

The purpose of this study is to confirm the security, and detect the effect of the local administration in damaged nervous tissue, of autologous bone marrow stromal cells.

Full description

It is a clinical trial phase I, single center, non-randomized, uncontrolled, open prospective follow-up of a cohort of patients with chronic spinal cord injury (SCI) who were treated with autologous stromal cells of the bone marrow administrated locally (subarachnoid and intramedullar) by intrathecal microinjection and three months later, by lumbar subarachnoid administration. The minimum follow-up duration for each patient is 12 months after the first administration, or until death, if it occurs it before.

Enrollment: 12 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female with ages between 18 years and 60 years with of age or older functional sequelae chronically established by traumatic injury of the spinal cord (spinal segments between the vertebral bodies C6 and L1) and considered irreversible (not respond to any other treatment). In this study, the lesion is considered chronically established, when there are no signs of functional recovery after a minimum follow-up period of 6 months after the spinal cord injury. The upper age limit is justified by the low potential of in vitro expansion of bone marrow stromal cells over 60 years.
• Complete paraplegia, with loss of motor and sensory function below the lesion (grade A in the American Spinal Injury Association Impairment (ASIA) Scale .
• Spinal injury MRI morphologically visible, and without images that suggest spinal cord transection, with separation of the both ends of the spinal cord.
• Tracking evolutionary possibility after treatment protocol and to comply physiotherapy maintained throughout the follow up period.
• Written informed Consent according to good clinical practice (GCP) and local regulations, obtained before any study procedure.
• Hematological parameters and creatinine, serum glutamate oxaloacetate transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) in normal range according to laboratory standards, are accepted, however, small non-significant deviations according to the investigator.

Exclusion criteria

• Pregnancy and lactation
• Systemic disease represents an added risk to treatment
• Patients with questions about their possible cooperation in rehabilitation-physiotherapy treatments later, or negative report psychological assessment prior.
• Neuroimaging data showing spinal cord section with separation of the terminal portion of the spinal cord
• Current neoplastic disease diagnosed or treated in the previous five years
• Patients treated with hematopoietic growth factors or requiring stable anticoagulation
• Added neurodegenerative disease
• History of substance abuse, psychiatric illness or allergy to protein products used in the process of cell expansion
• HIV positive serology and syphilis
• Hepatitis B or Hepatitis C active According to the investigator's opinion if there are findings on physical examination, abnormal clinical test results or other medica relevant entries, social or psychosocial factors which might influence negatively the study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Mesenchymal stromal cell therapy

Experimental group

Description:

Autologous bone marrow adult mesenchymal stem cells expanded in vitro. Administered by Intrathecal injection (subarachnoid and intramedullary). Depending on centromedullary post-traumatic injury: bone marrow stromal stem cells administration (MSCs) at the minimum dose of 100x106 followed by subarachnoid administration of 30x106 MSCs,3 months later

Treatment:

Biological: Mesenchymal stromal cell therapy