Clinical trial NCT01833975: Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Spinal Cord Injury
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Spinal Cord Injury.
Keywords: Spinal Cord Injury stem cell
Lead sponsor: Chaitanya Hospital, Pune
Sponsor class: OTHER
First posted: 2013-04-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 .

Primary outcomes:
measure: Improvement in overall sensory for motor control using Frankel score.
timeFrame: 6 month
Secondary outcomes:
measure: Improvement in pain sensation and Significant changes in Muscle Tones from base line
timeFrame: 6 month
measure: -Improvement in sensory and motor dysfunction using ASIA( American spinal cord injury association ) Scale
timeFrame: 6 month
measure: Significant changes in Muscle Tones and Improvement in pain sensation from base line
timeFrame: 6 month
Other outcomes:
Locations:
city: Pune
country: India
facility: Chaitanya Hospital
state: Maharashtra
Study officials:
affiliation: CHAITANYA HOSPITAL
name: ANANT E BAGUL, M.S
role: PRINCIPAL_INVESTIGATOR
References: