Safety of Stem Cell Transplant

Autologous Stem Cell Transplant by Venal Puncture

March 5th, 2011

Safety Follow-up in 460 Patients

Report file:

Official Safety Report

Abstract

Background

Autologous stem cells show promise in preclinical animal models as a cell transplantation therapy for repair of the injured spinal cord, to supplement neural cells in Parkinson, Multiple Sclerosis, Cerebral Palsy and Stroke patients. The procedure of first choice to implant stem cells is by using an apheresis device. This procedure is safe and minimal invasive. This paper summarizes the experiences with autologous stem cell therapy and reports the results of 460 stem cell transplants. l


Methods and Results

A short review of the recent literature looking at the aspect side effects and safety and an oversight of the side effects, reported by post treatment surveillance of patients from American Cellular. American Cellular Center evaluates the side effects of transplantation with autologous stem cells, using a standard Post Treatment Survey.

In this paper, 460 patients with a venal puncture as procedure for delivery of the stem cells were reviewed for side effects, using the results of the Post Treatment Surveys. The results of these patients are compared with the side effects after lumbar puncture, reported in literature.

Conclusions

Within American Cellular Center, the incidence of Post Dural Puncture Headache is estimated as low as .9% (out of 460patients). There were no reported side effects concerning fever, skin rashes, shock or tachycardia. Therefore, the transplantation of autologous stem cells seems to be safe and the venal puncture is a safe and non-invasive procedure to inject the stem cells. The Post Treatment Survey is a useful tool to monitor the safety of the procedures.

Today, a few clinical trials have been accomplished using stem cells for transplantation. A small group of 16 patients with a complete spinal cord injury have been treated by autologous stem cells. This clinical trial has a follow up of 3 years and until now no side effects or unexpected adverse reaction were observed. Another study involved 9 complete spinal cord injury patients with a follow-up of 1 year.

They observed major improvements and no side effects. In both studies, MRI’s didn’t show any signs of malignancy. Another observation comes from a phase I/II study with autologous stem cells and multiple sclerosis patients. 21 patients with multiple sclerosis were treated and followed for a period of 3 years.

This study not only reported no unexpected side effects but showed also an improvement of the health situation of a part of the patients. All these studies used venal puncture as procedure to inject the stem cells.