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

详细信息    查看全文

• 作者：Humayoon Shafique Satti¹ ; ² ; ^{humayun225@gmail.com" class="auth_mail" title="E-mail the corresponding author} ; Akhtar Waheed³ ; Parvez Ahmed¹ ; Khalil Ahmed³ ; Zaineb Akram¹ ; ² ; Tariq Aziz³ ; Tariq Mehmood Satti¹ ; Nighat Shahbaz¹ ; Mehreen Ali Khan¹ ; Salman Akbar Malik³
• 关键词：clinical trial ; mesenchymal stromal cells ; spinal cord injury ; transplantation
• 刊名：Cytotherapy
• 出版年：2016
• 出版时间：April 2016
• 年：2016
• 卷：18
• 期：4
• 页码：518-522
• 全文大小：127 K

文摘

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 × 10⁶ 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.