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Autologous mesenchymal stromal cell transplantation for spinal cord injury: A Phase I pilot study.

Authors:
Humayoon Shafique Satti Akhtar Waheed Parvez Ahmed Khalil Ahmed Zaineb Akram Tariq Aziz Tariq Mehmood Satti Nighat Shahbaz Mehreen Ali Khan Salman Akbar Malik

Cytotherapy 2016 Apr;18(4):518-22

Armed Forces Institute of Rehabilitation Medicine, Rawalpindi, Pakistan.

Background Aims: Mesenchymal stromal cell (MSC) transplantation has immerged as promising therapeutic approach to treat spinal cord injury (SCI). In this pilot study, we investigated the safety of intrathecal injection of autologous bone marrow-derived MSCs in nine patients with SCI.

Methods: Patients with complete SCI at the thoracic level were divided into two groups: chronic (>6 months, group 1) and sub-acute SCI (<6 months, group 2), according to time elapsed since injury. MSCs were isolated by density gradient separation of autologous bone marrow harvested from the iliac crest. Cells were cultured in a Good Manufacturing Practice-compliant facility to produce clinical scale dose. After quality control testing, MSCs were injected back to patients by intrathecal injection. Safety was defined as absence of adverse event and side effects after 1 month after receiving the injection.

Results: Six patients had chronic SCI with a median duration of 33 months since date of injury (range: 10-55 months), and three patients were in sub-acute phase of disease. Each patient received two or three injections with a median of 1.2 × 10(6) MSCs/kg body weight. No treatment-related adverse event was observed during median follow-up of 720 days (range: 630-826 days) in group 1 and 366 days (range: 269-367 days) in group 2, respectively.

Discussion: This pilot study demonstrated that autologous MSCs can be safely administered through intrathecal injection in spinal cord injury patients. Further investigation through randomized, placebo-controlled trials is needed.

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http://dx.doi.org/10.1016/j.jcyt.2016.01.004DOI Listing
April 2016

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