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

Spinal Cord Injury. Clinical Trial

— SCI  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01833975
• Other study ID #: 00103
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: February 26, 2013
• Last updated: September 16, 2014
• Start date: September 2014
• Est. completion date: September 2016

Study information

• Verified date: September 2014
• Source: Chaitanya Hospital, Pune
• Contact: sachin S Jamadar, Dortho
• Phone: +918888788880
• Email: sac2751982[@]gmail.com
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury.

Intervention

Biological:
• Transplantation 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.

Locations

Country	Name	City	State
India	Chaitanya Hospital	Pune	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Chaitanya Hospital, Pune

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in overall sensory for motor control using Frankel score.		6 month	Yes
Secondary	Improvement in pain sensation and Significant changes in Muscle Tones from base line		6 month	Yes
Secondary	-Improvement in sensory and motor dysfunction using ASIA( American spinal cord injury association ) Scale		6 month	Yes
Secondary	Significant changes in Muscle Tones and Improvement in pain sensation from base line		6 month	Yes