What is SCINETUSA?
SCINETUSA is a clinical trial network of cutting edge spinal cord injury centers in the United States. SCINETUSA supports and conducts clinical trials of the newest promising therapies for chronic spinal cord injury in the United States.
What are the newest trials being tested?
The initial trials that the network are proposing to test are:
A Phase 2 trial to examine the safety and likelihood of umbilical cord blood mononuclear cells (UCBMC that are HLA-matched at least 4:6) transplanted into the spinal cord above and below the injury site, to be followed by a 6-week course of lithium, and randomized to a 3-month course involving overground locomotor training.
This trial will have 20 patients. The main goals of the trial will be to examine adverse events, viability of locomotor training, and neurological scores at 6 weeks, 6 months, and a year.
All the subjects must be ASIA A, have neurological levels between C5 and T10 (inclusive), at least a year after injury without significant medical problems that would interfere with the surgery, and be able to stand (weight-bearing) for at least an hour in a standing frame.
A Phase 3 trial to determine and compare the value of rehabilitation alone (overground locomotor training), lithium alone, UCBMC transplants alone, and UCBMC plus lithium treatment of subjects with chronic spinal cord injury.
A total of 240 subjects (age 18-64, C5-T10 inclusive) with chronic spinal cord injury (at least one year after injury, with stable neurological function) will be randomized to the four treatment groups.
The results examined will be motor and sensory scores (ASIA), locomotor score (WISCI), independence score (SCIM), and adverse events of each of the treatments.
If the results in these trials are promising, Phase 2 trials will be begun to extend the treatment to older subjects (age 65-80), younger subjects (age 8-17), higher quadriplegics (C1-C4), and lower lumbosacral injuries (T11-L1).
Patients will not be charged for the therapies.
Who is participating?
The centers that have shown interest in participating in these trials include:
- Brackenridge Hospital, Austin, TX
- University of Medicine & Dentistry of NJ at Newark & Kessler
- Mt. Sinai School of Medicine, New York
- Long Island Jewish Hospital, New York
- Kent State University & Rehab. Inst. of Michigan, Detroit
- Shephard Rehabilitation Center, Atlanta
- University of Colorado at Denver
- Shriner’s Hospital in Philadelphia
Currently, a network in China (ChinaSCINet) is carrying out Phase 2 trials to evaluate the effects of escalating doses of UCBMC.
In 2011, ChinaSCINet and SCINETUSA are planning to execute their phase 3 trials in parallel (Note: The U.S. FDA requires two trials in parallel to approve therapies.)
Both ChinaSCINet and SCINETUSA will test the most promising therapies for chronic spinal cord injury rigorously, in clinical trials that meet the highest medical, ethical and scientific research standards.
These trials are also being considered in India and Norway, as well as in other centers in the U.S.
Just the beginning!
UCBMC and lithium are the first therapies that will be tested by these networks. If the combination of UCBMC and lithium together is effective, other therapies will be tested in comparison.