INDIA'S STEM-CELL PROGRAM
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INDIAíS STEM-CELL PROGRAM

Corinne Jeanmaire & Laurance Johnston, Ph.D.

With respect to spinal cord injury (SCI), we have become an interconnected global community, and, as such, what happens on the other side of the world ultimately affects all of us. India is one country that is playing an increasing role on the SCI world stage. Due to its large population, combined with rapid economic growth, the country has a huge SCI incidence, making the disorder a health-care priority.

In an attempt to develop some new solutions, Drs. Satish Totey (photo) and N.K. Venkataramana, and colleagues from Bangaloreís Manipal Hospital have initiated a pilot study evaluating the effectiveness of implanting patient-derived, bone-marrow stem cells into the injured cord. To learn more about this approach, the primary author, Corinne Jeanmaire recently traveled to Bangalore to visit the Manipal Hospitalís stem-cell clinic.

Transplanted Cells

Based on animal research, the investigators chose to transplant bone-marrow-derived mesenchymal stem cells, which are considered jack-of-all-trades stem cell due to their therapeutic potential. The cells are extracted from the patientís iliac crest (hip); assessed for genetic stability, infection, and identifying markers; and grown in culture for 14-20 days, producing 100-million cells. Because the cells are isolated from the patient and not anyone else, there is no rejection potential.

About 1 million stem cells per kilogram of body weight are injected by lumbar puncture into the spinal-cord fluid. This is a relatively noninvasive intrathecal procedure that does not require a laminectomy to surgically access the cord. Studies suggest that the stem-cells migrate to the injury site when transplanted this way. The procedure is repeated two weeks later.

Recruitment

The study recruited individuals who had sustained a complete injury within one to six months of enrollment. (a complete injury defined as the lack of sensation or motor control below the injury level three weeks post trauma.) At the time of this report, 12 patients from southern India had been treated, and 7 additional ones were being recruited. Although treatment is provided without expense, subjects need to organize their own post-transplantation rehabilitation program, often a challenging process in India.

Recruitment was aggravated because many potential subjects are not in good physical shape due to inadequate post-hospital care and lack access to beneficial information. Furthermore, to be a study participant, subjects had to be able to travel to Manipal Hospital ten times, including visits for initial check-up, cell aspiration, two treatment injections, and six follow-up visits.

Preliminary Results

To evaluate potential improvements accruing from the stem-cell transplantation, various electrophysiological (measuring nerve conduction), magnetic resonance imaging (MRI), and clinical assessments periodically took place up to three months after transplantation.

Although still preliminary and subjective in nature, the three-month final assessments completed in the earliest recruited subjects indicate some recovery in sensation and bowel-and-bladder function. After completion of this preliminary study, the results will be published, and, if warranted, a more rigorously designed, double-blind-clinical trial initiated.

Concluding Insights

Venkataramana emphasizes there is currently a lot of hype around stem-cell treatments and, as such, we should be careful not to generate false hope. Even though stem-cell therapies will inevitably help many in the future, there are numerous unanswered questions. For example, in the case of his program, What are the optimal number of cells to transplant? What is the best time after injury to inject the cells? Another key question is, How many cells actually reach the injury site via intrathecal implantation?

In theory, stem-cell migration and final deposition could be assessed by tagging the cells with a marker that could be followed. Also, the investigators would like to evaluate the potential synergistic role of neuronal growth factors in enhancing transplantation effectiveness. Finally, although enthusiastic about the potential of stem cells, Venkataramana stresses that this high-tech therapy must be considered in the context of a much greater need to improve Indiaís acute and rehabilitative care for SCI.

Adapted from article appearing in November 2006 Paraplegia News (For subscriptions, call 602-224-0500) or go to www.pn-magazine.com

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