Clinical trial NCT01186679: Safety and Efficacy of Autologous Bone Marrow Stem Cells in Treating Spinal Cord Injury
Official title: Surgical Transplantation of Autologous Bone Marrow Stem Cells With Glial Scar Resection for Patients of Chronic Spinal Cord Injury and Intra-thecal Injection for Acute and Subacute Injury - A Preliminary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Spinal Cord Injuries
Lead sponsor: International Stemcell Services Limited
Sponsor class: INDUSTRY
First posted: 2010-08-23
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The projected data related to the burden of spinal cord injuries induced limb paralysis in India is quite alarming. This is attributed to the rapid industrialization and economical development in the country. Increase in vehicular traffic has caused numerous road traffic accidents. Rapid increase in populations, development in the computer technology and real estate business lead to construction of huge buildings which indirectly adds to the injuries due to fall. Spinal cord injuries could not be treated adequately with the prevailing treatment modalities. In view of this, there is definitely an urgent need for finding different methods of treatment for these patients who cannot undergo established modalities of treatment or these have been tried unsuccessfully. Since a large number of these patients will loose their productive life and at the prime of their lives, one such alternate therapy, which seems to offer some promise, is "stem cell" therapy, which has been well studied and published in prestigious journals.

In our present study, we want to evaluate the safety and efficacy of autologous bone marrow derived stem cells surgically transplanted directly into the lesion site with glial scar resection for 8 indian patients of chronic spinal cord injury and intra-thecal injection for 4 indian patients of acute and subacute injury.


Eligibility criteria: Inclusion Criteria:

1. Must be able to give voluntary (patients may not be able to write) consent.
2. Must be able to understand study information provided to him.
3. Patients with complete spinal cord trans-section: at least post 6 months after spinal cord Injury (in chronic patients), \< 2 weeks in acute category and 2-8 weeks in subacute patients.
4. The level of spinal cord injury must be between C4 and T12(neurological level)
5. Spinal cord injury categorized in terms of ASIA Impairment scale.
6. Age should be between 20-55 years

Exclusion Criteria:

* Mechanical ventilation due to neurological impairment
* Multiple level trauma
* Undetermined size and location of Spinal Cord injury
* Gunshot or other penetrating trauma to the spinal cord
* Longitudinal dimension of injury by MRI is greater than 3spinal segments
* Associated severe head injury
* More than 9cms long bone fracture
* Women who are pregnant or lactating
* Serious pre-existing medical conditions
* Disease or impairment that precludes adequate neurological examination.
* Should not have co-morbidities like Diabetes, Systemic Hypertension etc.
* Severe co-morbidities/bed sores Tests positive for infectious diseases Deranged Coagulation profile and Hb \< 8mg/dl

Primary outcomes:
measure: Number of Participants with adverse events as a measure of safety and tolerability. Significant clinical improvement in ASIA impairment scale and general condition
timeFrame: 18 months
Secondary outcomes:
measure: Changes in the MRI, Neurological improvement (cranial/spinal reflexes) and evoked potentials study
timeFrame: 18 months
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Sita Bhateja Speciality Hospital
state: Karnataka
Study officials:
affiliation: Sita Bhateja Speciality Hospital
name: Dr.Arvind Bhateja, MCh.Neurosurgery
role: PRINCIPAL_INVESTIGATOR
References: