The OS for regenerative medicine — for the joints you follow for years after a procedure
iksa is the harness for n‑of‑1 medicine. Years on, you can tell patients what followed the procedure, because whoever times the next climb finds how you ran their stairs before the needle.
You write down before the procedure what would count as a change, since each of these readings has its own error
Your patients pay for a procedure themselves, on evidence you read closely, and ask you if it worked, and in a trial of one the answer has to come from the joint. How the knee feels can’t say what the procedure did, since in the saline arms of knee trials pooled in Cartilage about half met responder criteria at six months.
- Before each procedure, then a year or more outJoint MRI: On the same scanner, sequences and reader, beside a standing film, it says which compartment a procedure is for. Cartilage moves too slowly to read inside six months, and marrow edema can change by half in twelve weeks either way in a Manchester series.
- Before the procedure, with a practice run, then at three, six and twelve monthsStair-climb: The flight, the handrail rule and the person timing stay fixed. On nine steps, a six-month retest of people awaiting joint replacement, in BMC Musculoskeletal Disorders, put the smallest real change near 5.5 seconds, a borrowed bar.
- At the same visits, in the same orderChair stand and 40 m walk: These complete OARSI’s core set. In Physiotherapy Research International, among people also awaiting replacement, the first attempt differed from later ones, so a baseline with no practice run makes every re-test look better.
- Twice before, weeks apart, then at one, three, six and twelve monthsPain and function scores: People come to you on a bad stretch. In the Osteoarthritis Initiative, pain read 0.9 points lower on a 10-point scale a year after people met a trial’s entry bar and a year before it too, with no trial behind them, so two baselines tell you how much of the after is just that patient’s average.
The patient asked if it had worked, and at six months their stair‑climb couldn’t say, which is what the doctor told them
Scores six months after a needle can say almost anything, so the doctor went by what could be timed: 13.6 seconds from 14.4 before the first injection, inside this test’s error.
How long does your protocol follow a joint after a procedure, and what gets measured at the last visit?
Request a walkthroughRequest a walkthrough for regenerative medicineYou get one chance at a before, because a procedure can’t be stopped, washed out or repeated blind
A trial answers that with a sham arm and a blinded assessor, neither of which a clinic can run around a patient paying for their own knee. The record of what happened sits with the doctor who did the procedure.
Blinded assessment
The person timing a trial’s stairs doesn’t know what was done. In your clinic the person with the stopwatch does, so your protocol fixes the run in writing.
Data capture
What went in and where is in a procedure note, the MRI is a PDF, the patient’s scores are on a form and their stair time is in someone’s handwriting, so seeing what followed which procedure means laying it all out by hand.
Safety reporting
The patient was told to expect a sore knee, so the hot one that needs aspirating that day can pass as more of the same. In 15,021 steroid injections reported in the Archives of Orthopaedic and Trauma Surgery, the rare joint infections surfaced as late as 16 weeks.
Control arm
The largest blinded platelet-rich plasma trial, against saline in JAMA, and a head-to-head in Nature Medicine of marrow, fat and cord cells against a steroid were negative. Pooled in The American Journal of Sports Medicine, 18 placebo-controlled trials favor platelet-rich plasma at every follow-up, and only high-platelet preparations clear the smallest change that matters for pain. A control arm is how a trial tells a better month from the procedure, and counting the patient who had their knee replaced elsewhere is how your numbers stay whole.
A year on, whoever times the patient’s stairs has to run them exactly the way they were run before the first injection
The harness works inside the follow-up the doctor wrote, where the flight, the handrail rule and the practice run wait, however long the patient has been away.
When the patient asks for a second injection, the doctor opens what was done in the first and what was measured around it
Clinical Intelligence brings back the procedure note and the notes before and after it, quoted and cited, with the MRI as the doctor wrote about it, and a stair-climb nobody wrote down before the first procedure shows up as a gap.
Clinical Intelligence: clinical AI and lab trackingThe nurse holds the stopwatch, and can see how the last stair-climb was run before timing this one
Your nurse can ask Clinical Intelligence what the last note says about that run. When a patient writes that they’d skip the twelve-month visit, Agentic CRM drafts from the answers you approved and waits for your team, and if the patient mentions pain or swelling it goes to a person with no draft.
Agentic CRM: scheduling and follow-upA patient’s knee that turns hot weeks after the needle is the first thing Patient AI asks about, whatever they came to ask
Patient AI explains their stair-climb and their scores from what the doctor wrote about each. A hot, swollen knee gets safety questions first and can reach their nurse or doctor, and a warning sign your note names is one those questions are told to flag.
Patient AI: the treatment companion
Follow-up past a year is what this field has least of, and joints timed the same way are where it could start
A review of saline arms in Cartilage found too few studies at 12 and 24 months to pool. Once each patient has consented and identifiers are out, a research group would first ask who to compare the knees you’ve timed with. How a first study would find its comparison group →
The questions that come up once you start timing the stairs
Can we keep our own questionnaires and our own MRI reader?
Both stay yours.KOOS, WOMAC or a 0 to 10 pain scale go in your note, and iksa files each MRI report by date and kind and goes by what you wrote about it, whether your reader scores on MOAKS or gives a plain grade. What counts as change is yours too.
Can a repeat procedure be read against the first?
Side by side.Clinical Intelligence can set out what you wrote before and after each one, years apart, with the source behind every line. Whether the second before is a fair baseline is your reading, since nothing washes the first procedure out of that knee.
Patients stop coming in once the knee feels better. Can we still follow them?
Through your nurse.A twelve-month stair-climb you write in a note goes on that patient’s plan. If they stop replying they drop down your nurse’s list, and your nurse can ask for a suggested message drawn from the patient’s last conversation, then send it or leave it.
A patient read something online about what this does to cartilage. What does Patient AI tell them?
What your note says.It answers from their record and explains what you wrote about their knee, contested evidence included. If they ask for a second injection, they’re told the decision is yours and, if they agree, your nurse hears about it.
Where do cell therapy and exosomes stand with FDA and the states?
One MSC approval, none for a joint.FDA has approved one mesenchymal stromal cell therapy, for children with steroid-refractory acute graft-versus-host disease, none for aging or a joint, and, its consumer alert says, no exosome product. Without approval, a procedure stays inside section 361: tissue minimally manipulated, for homologous use, not combined with another article, and either acting locally without relying on living cells or used in the same patient or a close blood relative; anything else is a drug or biologic needing an IND or a license. Tissue taken out and put back unchanged in the same operation falls outside these rules, as do platelet-rich plasma, a blood product made with a cleared device, and minimally manipulated bone marrow for homologous use. Florida lets physicians use unapproved cell therapy for orthopedics, wounds and pain, from an accredited, FDA-registered facility, with the patient’s signed consent and the lot’s post-thaw viability report, though a federal appeals court has held a fat-derived preparation to be a drug, and the Supreme Court declined to hear it.
Another clinic nearby offers the same procedure for less. What does this give me?
Each patient’s own numbers.When a patient asks what happened, you can show their own stair-climb and scores from before and after, taken the same way. iksa won’t tell you or them that a procedure worked, because that’s your medicine to say, and it’s a conversation that clinic can only have if it measured too.
We chart every procedure in a system I’m not giving up. Does it stay?
Yes, all of it.Your EHR keeps the visit and the procedure note, and iksa reads them by connection or by upload. The stair times and MRI reports scattered around that chart today line up here on either side of each procedure, with what you decided on them.
I’m comparing regenerative medicine software. Will an OS for regenerative medicine tell me whether a procedure worked?
No, you will.We call it the harness for n‑of‑1 medicine, because a procedure can’t be taken back, which leaves each joint with one before, and it holds that before and every after for as long as you follow the joint, with what they mean still yours to say.
What is n‑of‑1 medicine?All practicesiksa beside your EHRProtocol management softwareWhat iksa addsA clinic group on iksa
Pick one procedure you follow, and let’s look at what you measure before it, after it and for how long
Bring a protocol you run. We’ll walk one patient through it.