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

Abstract：

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.

journal_name

Cytotherapy

journal_title

Cytotherapy

authors

Satti HS,Waheed A,Ahmed P,Ahmed K,Akram Z,Aziz T,Satti TM,Shahbaz N,Khan MA,Malik SA

doi

10.1016/j.jcyt.2016.01.004

subject

Has Abstract

pub_date

2016-04-01 00:00:00

pages

518-22

issue

4

eissn

1465-3249

issn

1477-2566

pii

S1465-3249(16)00015-3

journal_volume

18

pub_type

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