NCT01833975

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Chaitanya Hospital, Pune · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Spinal Cord Injury.

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2013-04-17
• Last updated: 2014-09-17

Locations

1 site across 1 country: India