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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02245776
Other study ID # NGBSI-16
Secondary ID
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date December 2008
Est. completion date December 2018

Study information

Verified date October 2018
Source Neurogen Brain and Spine Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study was to analyze the benefit of autologous mononuclear cell therapy in incurable neurological disorders.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2018
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender All
Age group 6 Months to 80 Years
Eligibility Inclusion Criteria:

- diagnosed cases of incurable neurological disorders

- age above 6 months

Exclusion Criteria:

- presence of acute infections such as Human immunodeficiency virus/Hepatitis B Virus/Hepatitis C Virus

- malignancies

- bleeding tendencies

- pneumonia

- renal failure

- severe liver dysfunction

- severe anemia [Hemoglobin < 8]

- any bone marrow disorder

- space occupying lesion in brain

- other acute medical conditions such as respiratory infection and pyrexia

- pregnancy

- lactation

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Stem Cell
Intrathecal autologous bone marrow mononuclear cell transplantation

Locations

Country Name City State
India Neurogen brain and spine institute Navi Mumbai Maharashtra

Sponsors (1)

Lead Sponsor Collaborator
Neurogen Brain and Spine Institute

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in various clinical symptoms of neurological disorders Change in various symptoms such as muscle strength, limb strength, ambulation, neck holding, bladder bowel management, spasticity, sensation, speech, etc depending on the disorder will be recorded at 1 year follow up. Percentage analysis of each symptom will be carried out to study the benefits of stem cell therapy on them. 1 year