For Investigators
Frequently asked questions
The questions practices actually ask when they are deciding whether this is worth their time. Where the honest answer is that something has not been finalised, that is what it says.
Anything marked as still to be confirmed is a real gap, not a formality. We would rather list it than fill it in with a guess.
What participation involves
How much of my time will this take?
The investigator's own time is concentrated at three points: training and site activation before the study opens, screening and consent discussions during enrolment, and the clinical assessments the protocol requires at each visit. Between those, most of the day-to-day work sits with the coordinator.
The honest answer is that the total depends entirely on the protocol — visit frequency, assessment burden and enrolment target are what drive it, and none of those are fixed yet. We will give every candidate site a specific estimate, in hours, before asking for any commitment. Placeholder, information still required: [TODO: confirm with MDRing — expected investigator and coordinator hours per enrolled participant, once the protocol is drafted.]
What staff do we need in place?
At minimum: a principal investigator, a study coordinator with meaningful time protected for this work, and someone responsible for regulatory documents and IRB correspondence. In smaller practices the last two are often the same person, which works as long as the time is genuinely allocated.
Because this is a frozen cell product, a site also needs staff trained to receive, store, document and thaw it correctly, and appropriate storage with temperature monitoring. Practices that already infuse biologics usually have most of this; practices that do not will need to build it. We assess this during site evaluation rather than at activation, so that nobody discovers a gap late.
Do we need prior clinical trial experience?
It helps considerably and it is one of the criteria we assess, but it is not a requirement. Practices running their first study can participate if there is a physician prepared to lead it, a realistic plan for coordinator time, and a willingness to work to research documentation standards — which are higher than routine clinical charting.
In markets built on the pairing model, a less research-experienced practice is often paired with an established research site, which makes the first study considerably easier to get through.
Are participating sites compensated?
Sites in clinical studies are normally covered through a per-participant budget set out in the clinical trial agreement, reflecting the actual work the protocol requires — visits, assessments, coordinator time and administrative overhead. That is the model we expect to use.
Placeholder, information still required: [TODO: confirm with MDRing — the site budget model, payment schedule, and the terms of the clinical trial agreement.]
Ethics and regulatory process
How does the IRB process work, and who handles it?
An institutional review board is an independent ethics committee that must approve the study for your site before you enrol anyone, and it keeps reviewing while the study runs. It can require changes, pause enrolment, or withdraw approval.
MDRing supplies the protocol, investigator brochure and the model consent document, and supports the site in preparing its submission. The site remains responsible for its own correspondence with the board, for reporting to it as required, and for maintaining its regulatory file. Placeholder, information still required: [TODO: confirm with MDRing — whether a single central IRB will serve the network or sites will use local boards, and who bears the review fees.]
What exactly am I responsible for as an investigator?
The standard duties of a clinical investigator: obtaining and documenting informed consent using the approved document, following the protocol and documenting any deviation, recording and reporting adverse events within the required timelines, maintaining source documentation and drug accountability records, and making your records available to monitors, auditors and the FDA.
The Compliance page sets these out in detail. None of them are unusual, but all of them are real, and a practice should look at the list before it agrees to anything.
Can we treat patients outside a study if we join?
No. Administration of this investigational product within the network happens inside a study conducted under the FDA's investigational pathway, under an approved protocol, with IRB approval for that site. The same standard applies to every site regardless of where it is located.
This is not a technicality we work around; it is the basis on which the network is built. A practice looking for a route to offer the therapy outside a study is not a fit for this programme.
Data, product and operations
What data systems will we be using?
Study data is captured in a central electronic data capture system maintained by the sponsor, against source documentation held at the site. Sites are trained on the system before activation, and data is monitored against the protocol during the study so that issues surface while they can still be corrected.
Participants are also enrolled into a registry that follows outcomes over time. The registry sits alongside the study's case report forms and does not replace them. Placeholder, information still required: [TODO: confirm with MDRing — the EDC platform, the monitoring plan, registry scope and data ownership terms.]
What training do we receive, and how is the product handled?
Investigator and staff training covers the protocol and its procedures, the consent process, adverse event recognition and reporting, documentation standards, and the handling of the product itself — receipt, storage, temperature monitoring, thaw and administration.
The product is manufactured in advance, frozen and shipped to the site, so there is no wait for manufacturing and nothing is collected from the participant first. Each batch arrives with release documentation, including testing confirming the identity, purity and activity of the cells and a report of viability after thaw. Placeholder, information still required: [TODO: confirm with MDRing — the training programme's format and duration; and with Cellenkos, the full documentation set supplied to investigational sites.]
Can we publish, or present our own results?
Multi-site studies normally pool data and publish centrally, with participating investigators credited according to a prespecified authorship plan, and site-level publication governed by the clinical trial agreement. We expect that structure here.
Placeholder, information still required: [TODO: confirm with MDRing — the publication policy, authorship approach, and any site-level publication rights.]
Selection, scope and timing
How are sites selected?
Against seven criteria, set out in full on the Opportunity page: a clinically relevant patient population, experience with advanced therapies, clinical research experience, the ability to collect good data, readiness to run an FDA-supervised study, investigator standing, and research operations capacity.
Markets are chosen on clinical and research strength — the concentration of relevant specialists, research infrastructure, and practices with existing trial experience. We are selecting a small number of sites per market rather than recruiting broadly.
What does the pairing model mean for my practice?
Most markets are built as a pair: one rheumatology research site and one regenerative or sports medicine practice. The two see different patients and bring different strengths, and together they cover more of what a study in these conditions has to answer.
They are not competing for the same participants. Eligibility is set by the protocol, and the two practices generally draw from different populations. Pairing also means a market is not lost if one site cannot activate.
What condition will the first study target, and when does it start?
Not yet determined. The indication for the first study has not been finalised, and the final market and site list depends on that decision — a study in immune-mediated arthritis and a study in degenerative joint disease need partly different sites.
We are evaluating and preparing sites now so that the network is ready when a protocol opens, rather than starting recruitment from nothing at that point. Placeholder, information still required: [TODO: confirm with MDRing — the indication for the first study, its regulatory status, and the anticipated timeline to first site activation.]
Is there evidence this works in joint or autoimmune conditions?
No. There is no clinical data on this therapy in arthritis or any joint condition, and we will not present it as though there were. Cellenkos's existing studies are in aplastic anemia, ALS, Guillain-Barré syndrome, myelofibrosis and COVID-19 lung failure — serious diseases, and not these ones.
There is a scientific rationale, drawn from observational and laboratory work, and the Science page sets out both what supports it and why it falls well short of proof. Closing that gap is the reason the network exists. Any practice joining should treat every joint and autoimmune use as unproven until these studies report.
Still have a question?
Send it. Questions from physicians evaluating a research role get a direct answer, including when the answer is that we do not know yet.
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