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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Efficacy of Stem Cell Therapy in Spinal Cord Injury

NCT02027246

Spinal Cord Injury

WITHDRAWN PHASE1

Stem Cell Therapy in Spinal Cord Injury

NCT02009124

Spinal Cord Injury

WITHDRAWN PHASE2

Safety and Efficacy of Autologous Bone Marrow Stem Cells in Treating Spinal Cord Injury

NCT01186679

Spinal Cord Injuries

COMPLETED PHASE1/PHASE2

To Study the Safety and Efficacy of Autologous Bone Marrow Stem Cells in Patients With Spinal Cord Injury

NCT01730183

Spinal Cord Injury

UNKNOWN PHASE1/PHASE2

Intrathecal Transplantation of UC-MSC in Patients With Sub-Acute Spinal Cord Injury

NCT03521336

Spinal Cord Injury

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Cord Injury.

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

stem cell [ MNCs ]

transplantation of autologous stem cell \[MNCs \]

Group Type OTHER

Transplantation of Autologous stem cell [MNCs] .

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Autologous stem cell[MNCs] .

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 .

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes