NCT01833975

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 17, 2013

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 17, 2014

Status Verified

September 1, 2014

Enrollment Period

2 years

First QC Date

February 26, 2013

Last Update Submit

September 16, 2014

Conditions

Spinal Cord Injury.

Keywords

Spinal Cord Injury stem cell

Outcome Measures

Primary Outcomes (1)

  • Improvement in overall sensory for motor control using Frankel score.

    6 month

Secondary Outcomes (3)

  • Improvement in pain sensation and Significant changes in Muscle Tones from base line

    6 month

  • -Improvement in sensory and motor dysfunction using ASIA( American spinal cord injury association ) Scale

    6 month

  • Significant changes in Muscle Tones and Improvement in pain sensation from base line

    6 month

Study Arms (1)

stem cell [ MNCs ]

OTHER

transplantation of autologous stem cell \[MNCs \]

Biological: Transplantation of Autologous stem cell [MNCs] .

Interventions

Transplantation of Autologous stem cell [MNCs] .BIOLOGICAL

Intra thecal transplantation of Autologous stem cell \[MNCs\],100millions per dose in 3 divided doses at interval of 10 days.

Also known as: Autologous stem cell[MNCs] .
stem cell [ MNCs ]

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chaitanya Hospital

Pune, Maharashtra, 411009, India

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • ANANT E BAGUL, M.S

    CHAITANYA HOSPITAL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

sachin S Jamadar, Dortho

CONTACT

+918888788880sac2751982@gmail.com

Smita s Bhoyar, B.A.M.S.PGCR

CONTACT

9372620569drsmitabhoyar@rediff.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
C0- Investigator

Study Record Dates

First Submitted

February 26, 2013

First Posted

April 17, 2013

Study Start

September 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

September 17, 2014

Record last verified: 2014-09

Locations

IN(1)