## Protocol Section
### Identification Module
**NCT ID:** NCT01186679

**Acronym:** ABMST-SCI

**Brief Title:** 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

#### Organization Study ID Info
**ID:** ISSL-AuBM-SCI
#### Organization
**Class:** INDUSTRY
**Full Name:** International Stemcell Services Limited
### Status Module
#### Completion Date
**Date:** 2010-08

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2010-08-23

**Type:** ESTIMATED

**Last Update Submit Date:** 2010-08-20

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2010-02

**Type:** ACTUAL

#### Start Date
**Date:** 2008-01

**Status Verified Date:** 2010-08

#### Study First Post Date
**Date:** 2010-08-23
**Type:** ESTIMATED
**Study First Submit Date:** 2010-08-20
**Study First Submit QC Date:** 2010-08-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** International Stemcell Services Limited

#### Responsible Party

**Old Name Title:** Dr.SGA.Rao, Chairman

**Old Organization:** International Stemcell Services Ltd.

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Spinal Cord Injuries

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 12

**Type:** ACTUAL

**Phases:**

- PHASE1

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 1. Surgical transplantation into the lesion site in chronic patients
2. Direct intrathecal implantation in acute and subacute patients

**Intervention Names:**

- Procedure: laminectomy

**Label:** Intralesional

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** direct into the CSF through lumbar puncture

**Intervention Names:**

- Procedure: Intrathecal

**Label:** intrathecal

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intralesional

**Description:** surgical laminectomy with glial scar resection

**Name:** laminectomy

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- intrathecal

**Description:** direct into the CSF through lumbar puncture

**Name:** Intrathecal

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** American Spinal Injury Assessment scale of A,B,C,D or E

**Measure:** Number of Participants with adverse events as a measure of safety and tolerability. Significant clinical improvement in ASIA impairment scale and general condition

**Time Frame:** 18 months

#### Secondary Outcomes

**Description:** MRI findings of the lesion, Nerve conduction studies of the region and somatosensory evoked potentials of the same region

**Measure:** Changes in the MRI, Neurological improvement (cranial/spinal reflexes) and evoked potentials study

**Time Frame:** 18 months

### Eligibility Module

**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

**Maximum Age:** 55 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bangalore

**Country:** India

**Facility:** Sita Bhateja Speciality Hospital

**State:** Karnataka

**Zip:** 560025

#### Overall Officials

**Official 1:**

**Affiliation:** Sita Bhateja Speciality Hospital

**Name:** Dr.Arvind Bhateja, MCh.Neurosurgery

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000013118

- Term: Spinal Cord Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000020196

- Term: Trauma, Nervous System

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M15916

- Name: Spinal Cord Injuries

- Relevance: HIGH

- As Found: Spinal Cord Injury

- ID: M6160

- Name: Cicatrix

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: HIGH

- As Found: Injury

- ID: M15915

- Name: Spinal Cord Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22023

- Name: Trauma, Nervous System

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000013119

- Term: Spinal Cord Injuries

- ID: D000014947

- Term: Wounds and Injuries

### Misc Info Module

- Version Holder: 2024-05-24
