None listed
Conditions
Interventions
Intervention1: Bone Marrow derived Adult Stem Cells: 20 ml of Achieved concentrate from 120ml of aspirate adult stem cells
Control Intervention1: NIL: NIL
Sponsors
Dr. Himanshu Bansal Foundation
ClinFOX International
Eligibility
Inclusion criteria
Inclusion criteria: 1. Be a Male/Female of ages 18 to 65 years 2. Who is properly informed of the nature and risks of the clinical study, who is willing and capable of complying with all clinical study procedures, and has given informed consent in writing prior to entering the clinical study. Subjects who are willing to comply with the study procedure. 3. Be with complete spinal cord injury (ASIA level A) 4. Time between injury and enrollment is greater than or equal 1 month and less than or equal to 1 year 5. Have Platelet count > 100 Thousand/µL at screening 6. Have White Blood Count < 15,000 7. International Normalized Ratio (INR) less than or equal to 1.5 8. Hematocrit < 30% prior to bone marrow aspiration 9. Have the neurological level is between C5 and T10 10. Have complete or partial transaction/damage as shown by MRI
Exclusion criteria
Exclusion criteria: x. Ongoing Alcohol/ Substance Abuse. x. Intoxication, Intubation, Sedation and Immobilization x.Osteoporosis or low bone mass as determined by medical history or DXA x. Cancer over last 3 years prior to enrollment x. Presence of a primary Hematological disease or any coagulation abnormalities or concomitant treatment with coumarin anti-coagulant x. Implanted Medical Devices like Cardiac Stents, Pace Makers, Bladder Stimulators and Permanent modification of Anatomy x. Uncontrolled Diabetes, Hypertension, Auto Immune Disease, Psychiatric illness, terminal Renal Failure with existing dependence on dialysis and history of Bone Marrow diseases x. Possibility of non-compliance with the protocol. x. Subjects with Syringomyelia, Spinal Stenosis, Plexopathy, Neuropathy, Radiculopathy, Cauda Equina Injury, Myelitis, Demyelination, Ischemia, Severe Spinal Degenerative Pathologies, Ongoing Focal Spinal Cord Compression or anatomically complete lesions x.Longitudinal dimension of injury more than 3 segments x. Women who is pregnant or nursing or of child-bearing potential unwilling to use effective barrier method of contraception for the duration of the study x.No informed consent. x. Signs of Meningitis with Fever (above 39°C) x. Coma or other severe injury or disease x. Penetrating injury x. Unsuitable based on MRI or other factor x. Subjects who have taken Immunosuppressant?s within the last one month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: &#61692; To Establish Safety Of Stem Cell Therapy In Patients With Complete Spinal Cord Injury &#61692; Incidence And Severity Of Adverse Events (Assessed Clinically And By Laboratory Assessments) Efficacy: &#61692; Clinical Improvement In The Neurological Function, Functional Capacity By ASIA Level A Score &#61692; Clinical Improvement In The Sensory Functions By SSEP/SEPs (Somatosensory Evoked Potential ) &#61692; Clinical Improvement In Bladder Function By Urodynamic StudiesTimepoint: 1.5 Years | — |
Secondary
| Measure | Time frame |
|---|---|
| &#61656; Evaluation of the changes in the neurological functions via different route of administration &#61656; Measurable improvement in the performance of Activities of Daily Living (ADL) using Spinal Cord Independence Measure (SCIM) Score &#61656; Spasticity (using Modified Ashworth Scale (MAS)) &#61656; Reduction in the use of Medicines. &#61656; Changes in Spinal MRI Finding Timepoint: 2 Years | — |
Countries
India
Contacts
Public ContactSreedhar Singamala
Outcome results
None listed