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

Phase 1

• Conditions: Spinal Cord Injury.
• Interventions: Biological: Transplantation of Autologous stem cell [MNCs] .

• Registration Number: NCT01833975
• Lead Sponsor: Chaitanya Hospital, Pune

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.

Study Timeline

• Study First Submitted: 2013-02-26
• Study First Submitted QC: 2013-04-15
• Study First Posted: 2013-04-17
• Status Verified: 2014-09
• Study Start: 2014-09
• Last Update Submitted: 2014-09-16
• Last Update Posted: 2014-09-17
• Primary Completion: 2016-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
stem cell [ MNCs ]	Transplantation of Autologous stem cell [MNCs] .	transplantation of autologous stem cell \[MNCs \]

Primary Outcome Measures

Name	Time	Method
Improvement in overall sensory for motor control using Frankel score.	6 month

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chaitanya Hospital; 🇮🇳 Pune, Maharashtra, India