Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Spinal Cord Injury

Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Spinal Cord Injury . It is Self Funded (Patients' Own Funding) Clinical Trial

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01833975

Acronym

SCI

Enrollment

Registered

2013-04-17

Start date

2014-09-30

Completion date

2016-09-30

Last updated

2014-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury.

Keywords

Spinal Cord Injury stem cell

Brief summary

This Study is a single arm,Phase I/II , single centre trial to check active comparing the safety and efficacy of Bone marrow derived autologous cell(100 million per dose) trial to be conducted for 36 months.

Detailed description

A spinal cord injury (SCI) refers to any injury to the spinal cord that is caused by trauma instead of disease.\[1\] Depending on where the spinal cord and nerve roots are damaged, the symptoms can vary widely, from pain to paralysis to incontinence.\[2\]\[3\] Spinal cord injuries are described at various levels of incomplete, which can vary from having no effect on the patient to a complete injury which means a total loss of function.Injuries at any level can cause:Increased muscle tone (spasticity),Loss of normal bowel and bladder control (may include constipation, incontinence, bladder spasms),Numbness,Sensory changes Pain,Weakness, paralysis. This Study is a single arm,Phase I/II , single centre trial to check active comparing the safety and efficacy of Bone marrow derived autologous cell(100 million per dose) trial to be conducted for 36 months.

Interventions

BIOLOGICALTransplantation of Autologous stem cell [MNCs] .

Intra thecal transplantation of Autologous stem cell \[MNCs\],100millions per dose in 3 divided doses at interval of 10 days.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Patient should suffer from Spinal cord injury. * willingness to undergo bone marrow derived autologous cell therapy. * patient those provide fully Informed consent form for the study. * Ability and willingness to regular visit to hospital and follow up during the protocol Procedures. * traumatic Injury of spinal cord with complete or partial damage by MRI and Spinal cord injury level should be below C4

Exclusion criteria

* Patient with pre- existing or current systemic disease such as Lung, liver,(exception:history of uncomplicated hepatitis A)gastrointestinal,cardiac , immunodeficiency(HIV) * History of life threatening allergic or immune - mediated reaction. * haemodynamically unstable patients. * patient suffer from peripheral muscular dystrophy. * lactating and pregnant woman * alcohol drug abuse /dependence * positive test result for hepatitis A and Hepatitis B OR C * Major-traumatic brain injury and patient with psychiatric illness .

Design outcomes

Primary

Measure	Time frame
Improvement in overall sensory for motor control using Frankel score.	6 month

Secondary

Measure	Time frame
Improvement in pain sensation and Significant changes in Muscle Tones from base line	6 month
-Improvement in sensory and motor dysfunction using ASIA( American spinal cord injury association ) Scale	6 month
Significant changes in Muscle Tones and Improvement in pain sensation from base line	6 month

Countries

India

Contacts

Primary Contactsachin S Jamadar, Dortho

sac2751982@gmail.com+918888788880

Backup ContactSmita s Bhoyar, B.A.M.S.PGCR

drsmitabhoyar@rediff.com9372620569

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026