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Studying the effect of bone marrow mesenchymal stem cell injection into the subarachnoid space on improvement and reduction of complications in spinal cord injured patients

Studying the effect of bone marrow mesenchymal stem cell injection into the subarachnoid space on improvement and reduction of complications in spinal cord injured patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013050813267N1
Enrollment
30
Registered
2014-02-06
Start date
2016-12-05
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Spinal Cord Injury. Injury Of Spinal Cord, Level Unspecified

Interventions

Intervention 1: In intervention group, at first bone marrow aspiration (10ml) will be done and mesenchymal stem cells will be collected using centrifuge and Ficoll solvent. Cells will be cultured and
Treatment - Surgery
Treatment - Drugs
In intervention group, at first bone marrow aspiration (10ml) will be done and mesenchymal stem cells will be collected using centrifuge and Ficoll solvent. Cells will be cultured and after proliferat
In control group just vehicle of cells (distilled water) with the same volume of intervention group (5ml) will be injected to the sub arachnoid space of patients. Injecting solvent will be injected sl

Sponsors

Shahid Sadoughi Yazd University Of Medical Sciences, Vice Chancellor for Research
Lead Sponsor

Eligibility

Sex/Gender
All
Age
13 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: filling the questionnaire by patient and his/her family; age 13-60; no more than 3 months passed from injury date, no history of cancer in patient and his family; no history to other chronic disorder; no other acute disease at present; self control on breathing; no contribution in the other studies; no convulsion and fever; no infectious diseases in patient like AIDS and hepatitis, and meningitis. Exclusion criteria: patient request; occurrence of fever and convulsion after cell therapy, occurrence of any other complication; infection, instability of patient's health conditions ; worsening of the patient's disease.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Evaluation of Generation of Ectopic Tissue Such as Tumor After Stem Cell Therapy. Timepoint: Three months after third injection. Method of measurement: MRI; Physical Examination; Biochemical Tests About Presence of Ectopic Tissue or Tumor in Patients.

Secondary

MeasureTime frame
Improvement In Somatic Sensation And Control Of Bladder , And Motor Function Improvements. Timepoint: 1 Month. Method of measurement: Physical Examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamid Hobobati

Shahid Sadoughi Yazd University Of Medical Sciences, Yazd, Iran

hh1358@gmail.com+98 35 1820 3410

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026