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Judging a therapy
Almost every family arriving at this subject is told the same two things: that something new is available, and that time matters. This page is the tool for the conversation that follows. It is not about saying no — it is about being able to tell the difference between a careful offer and a confident one.
The four levels used on this site
Every therapy page carries one of these badges, and often a different badge for each condition. The level describes the strength of the evidence, not how promising the idea is.
“Approved” is always approved for something
A licence is granted for a named condition, an age range and a specific product. Cord blood is a licensed medicine — for blood and immune disorders. That licence says nothing about cerebral palsy. Magnetic stimulation is cleared for depression in older adolescents in some countries; that clearance says nothing about autism.
When a clinic says a treatment is “approved”, the only useful follow-up is: approved by whom, for which condition, at what age?
What the trial phases mean
| Phase | Question it asks | What it cannot tell you |
|---|---|---|
| Preclinical | Does it work in cells and animals? | Anything about your child. Most treatments that work in rodent brain injury fail in people. |
| Phase 1 | Can it be given safely, and at what dose? | Whether it helps. Small numbers, often no control group. |
| Phase 2 | Is there a signal of benefit worth testing properly? | Whether the signal is real. Phase 2 results frequently do not survive phase 3. |
| Phase 3 | Does it work, compared with the alternative? | Rare long-term risks, and how it performs outside trial conditions. |
A clinic quoting a phase 1 study as proof of benefit is quoting a study that was not designed to measure benefit.
Eight things that should make you slow down
- It treats almost everything. Cerebral palsy, autism, epilepsy, Down syndrome and developmental delay are different problems with different biology. One product that helps all of them is a marketing claim, not a mechanism.
- You are asked to take part in “a study” on commercial terms. In a properly run trial the sponsor funds the research. Describing an unproven treatment as a study, outside that structure, avoids the scrutiny research properly carries.
- The evidence is videos and testimonials. Children with developmental conditions change over months anyway, and families who have hoped see change more readily. That is why controlled comparison exists.
- No control group is mentioned. Ask what the comparison was. If the answer is “before and after”, the study cannot separate the treatment from time, growth and the rehabilitation given alongside it.
- The outcome is vague. “More alert”, “better eye contact”, “calmer” are not measurements. Ask which scale, scored by whom, and at what interval.
- Repeat courses are built into the plan before the first one is assessed. A schedule of six infusions agreed upfront tells you the plan does not depend on whether the first one worked.
- Rehabilitation is discouraged or paused. Physiotherapy, occupational therapy and speech therapy have the strongest evidence base in this field. Anything that displaces them should be questioned hard.
- You are told to decide quickly. Biology does not run to a booking deadline. Urgency is a sales technique.
What a serious centre does
- Names the exact product, dose and route, in writing.
- Tells you plainly that it is investigational, if it is.
- Points you to the registry entry or the published studies, including the ones that were negative.
- Agrees a measurable outcome and a review date before starting.
- Keeps your child’s existing therapy and medication plan intact.
- Writes to the doctor who looks after your child, and accepts being contacted by them.
Deciding when the evidence is thin
Sometimes there is no good option and the honest answer is that nobody knows. Families still have to decide. Three things make that decision better rather than easier.
- Write down what would count as improvement — a specific, observable thing, agreed before you start, with a date to review it.
- Protect what already works. Keep therapy, medication and school going. A treatment that is not yet proven should be added to a good plan, never substituted for it.
- Decide the stopping point in advance, while you are still calm. “Two courses, then we reassess with our own neurologist” is a plan. “We will see how it goes” tends to become indefinite.
Whatever you decide, the clinician who knows your child should know what was given, when, and at what dose — not least because it changes how any later change is interpreted.
Next: the emerging treatments, or the evidence table if you want everything on one page.