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

Chaitanya Hospital, Pune

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Spinal Cord Injury.

Treatments

Biological: Transplantation of Autologous stem cell [MNCs] .

Study type

Interventional

Funder types

Other

Identifiers

NCT01833975

00103

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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 .