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Safety and Efficacy of Stem Cell Therapy in Spinal Cord Injury

Autologous Bone Marrow Mononuclear Cell Therapy for Spinal Cord Injury

Status
Withdrawn
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02027246
Enrollment
0
Registered
2014-01-06
Start date
2008-12-31
Completion date
2013-02-28
Last updated
2018-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury

Keywords

spinal cord injury, autologous bone marrow mononuclear cells, stem cell therapy

Brief summary

The aim of this study was to study the effect of stem cell therapy on common symptoms of spinal cord injury patients.

Detailed description

Autologous bone marrow mononuclear cells are administered intrathecally by a standard procedure followed by standard rehabilitation therapy.

Interventions

Bone marrow is aspirated by a standard procedure. Mononuclear cells are separated by density gradient method and then injected intrathecally by a standard lumbar puncture procedure

Sponsors

Neurogen Brain and Spine Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Months to 63 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosed cases of any type of chronic Spinal cord injury * 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 * other acute medical conditions such as respiratory infection * pregnancy and lactation

Design outcomes

Primary

MeasureTime frameDescription
Change in clinical symptoms6 monthsclinical symptoms were assessed based on the observation of the experts

Secondary

MeasureTime frameDescription
Functional Independence Measure (FIM)6 monthsFunctional Independence Measure (FIM) is a standard scale performed before and 6 months after the intervention to measure the functional ability of the patients.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026