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The Opportunity

A research role, not a product line.

MDRing Inc is building a national network of physician practices to serve as sites and investigators for clinical studies of an investigational cord-blood-derived regulatory T-cell therapy, developed by Cellenkos, in inflammatory joint and autoimmune conditions.

The network is in formation. We are identifying and evaluating practices now, ahead of study start, so that sites are trained, contracted and ready when a protocol opens. Participation means running a regulated study — not offering a therapy.

Why a practice would join

Three things a site gets that it cannot easily build on its own.

  • Early involvement with a distinct class of cell therapy

    Regulatory T-cell therapy approaches immune-mediated disease from a different direction than the biologic drugs most rheumatology practices already use. Participating sites work with the product under protocol from the beginning, and build genuine familiarity with a modality that is new to joint and autoimmune medicine.

  • A defined investigator role

    Sites take on a named investigator role in an FDA-supervised study, with the protocol training, monitoring relationship and documented research record that comes with it. For practices building or extending a research programme, this is a study to run rather than a service to sell.

  • Membership in a coordinated network

    Sites operate from a common protocol, shared training, a single safety reporting route and one data system, alongside other investigators working the same questions. Findings are pooled across the network rather than stranded in individual practices.

Two kinds of partner

The network is being built from two complementary groups. Most markets need both.

Partner type one

Regional practices

Individual practices and small groups in rheumatology, orthopedics, sports medicine and regenerative medicine, recruited market by market. These are the working sites: they see the patients, run the visits and generate the data.

  • One to three locations, usually within a single metro area
  • An established patient population in the conditions under study
  • Research experience ranging from seasoned trial sites to practices running their first study with support
  • Physician-led, with decision-making close to the clinic

Partner type two

Larger strategic networks

Multi-site orthopedic groups, rheumatology research organisations and physician alliances that can contribute several sites through a single relationship, along with established research operations.

  • Multiple locations, often across several states
  • An existing research division, coordinators and regulatory staff
  • Central contracting, which shortens the path from agreement to activation
  • The ability to scale a study across sites once the first ones are running

The regional pairing model

Rather than recruiting sites one at a time wherever we find them, we build markets in pairs: one rheumatology research site and one regenerative or sports medicine practice per metro area.

The two bring different things. Immune-mediated arthritis and degenerative joint disease are studied by different specialists, in different patients, with different outcome measures — and a market with both covers the range of questions a study in these conditions has to answer. Pairing also gives each market a second site if one cannot activate.

Site A

Rheumatology research site

A practice treating immune-mediated arthritis, with clinical trial experience and the research infrastructure to match.

What it brings

  • Patients with rheumatoid, psoriatic and related inflammatory arthritis
  • Familiarity with advanced therapies and trial protocols
  • Coordinators, regulatory staff and source documentation discipline
  • Established standards for measuring disease activity over time

Site B

Regenerative or sports medicine practice

A practice managing inflamed and degenerative joints in active adults, experienced with procedural care and structured consent.

What it brings

  • Patients with joint inflammation and degeneration outside classic autoimmune disease
  • High procedural volume and disciplined follow-up
  • Experience explaining investigational and elective options carefully
  • Functional and imaging outcome measures already in routine use

San Diego is the reference example of a complete pair. Placeholder, information still required: [TODO: confirm with MDRing — whether the San Diego pairing may be described publicly, and whether the practices involved have agreed to be identified.]

Target markets

We are building in metro areas with the clinical depth and research infrastructure a multi-site study requires: concentrations of rheumatology and orthopedic specialists, academic and hospital research capacity, and practices with existing trial experience. Markets are selected on those grounds alone.

Westchester, New YorkLong Island, New YorkThe Hamptons, New YorkGreenwich, ConnecticutNorthern Virginia, VirginiaBethesda, MarylandSan Francisco Bay Area, CaliforniaSanta Barbara, CaliforniaLos Angeles, CaliforniaOrange County / Newport Beach, CaliforniaSan Diego, CaliforniaScottsdale / Phoenix, ArizonaBoulder / Denver, ColoradoDallas, TexasThe Woodlands, TexasHouston, TexasAtlanta, GeorgiaPalm Beach, FloridaBoca Raton, FloridaBroward County, FloridaManhattan, New YorkNorthern New Jersey, New Jersey
  • Active target market (16)
  • Under consideration (6)

Markets by state

  • California

    • San Francisco Bay Area
    • Santa Barbara
    • Los Angeles
    • Orange County / Newport Beach
    • San Diego
  • Arizona

    • Scottsdale / Phoenix
  • Colorado

    • Boulder / Denver
  • Texas

    • Dallas
    • The Woodlands
    • Houston
  • Georgia

    • Atlanta
  • Florida

    • Palm Beach
    • Boca Raton
    • Broward County
  • New York

    • Manhattan
    • Westchester — under consideration
    • Long Island — under consideration
    • The Hamptons — under consideration
  • New Jersey

    • Northern New Jersey
  • Connecticut

    • Greenwich — under consideration
  • Virginia

    • Northern Virginia — under consideration
  • Maryland

    • Bethesda — under consideration

Map positions are indicative and drawn for orientation only. Markets under consideration are not yet committed, and the final market list depends on the condition a first study targets. Placeholder, information still required: [TODO: confirm with MDRing — the indication for the first study, and the resulting confirmed market list.]

What we look for in a site

Practices are evaluated against a consistent set of criteria. No single one is disqualifying on its own, and we expect strong sites to be stronger in some areas than others.

  1. A clinically relevant patient population

    Enough patients with the conditions a study would target, seen regularly enough to support realistic enrolment within the study window.

  2. Experience with advanced therapies

    Familiarity with biologics, infusions or other advanced treatments, including the handling, monitoring and documentation they demand.

  3. Clinical research experience

    A track record of running studies under protocol. Practices new to research are not excluded, but they need a credible plan for building the capability and a physician willing to lead it.

  4. The ability to collect good data

    Complete, accurate, timely records. Study data has to withstand monitoring and audit, which is a higher standard than routine clinical documentation.

  5. Readiness to run an FDA-supervised study

    Capacity to work under a protocol, an IRB approval and a monitoring plan — including the staff time, storage, temperature control and record-keeping a regulated study requires.

  6. Investigator standing

    A physician whose clinical judgement is respected by peers and who is prepared to be named as an investigator and stand behind the study's conduct.

  7. Research operations capacity

    Coordinator time, regulatory support and the administrative capacity to manage consent, scheduling, safety reporting and data entry alongside a working clinic.

A note on selection. The seven criteria above are the whole list — sites and markets are assessed on clinical and research grounds, and on nothing else. This is not only a matter of principle: an IRB is required to satisfy itself that subjects in a study are selected equitably, and a network built on any other basis would struggle to meet that standard. Participant eligibility is set by the protocol, on clinical criteria. Placeholder, information still required: [TODO: confirm with MDRing — the final, approved site selection criteria as they will appear in study documentation.]

What participating sites receive

Running a cell therapy study asks things of a practice that a drug trial does not. Sites are not expected to build that infrastructure themselves.

  • Investigator and staff training

    Protocol-specific training for the investigator and site staff, covering study procedures, product handling and thaw, documentation standards, and the regulatory obligations that come with an investigational product.

  • Study protocol support

    A protocol, investigator brochure and the supporting documents a site needs for IRB submission, together with help preparing that submission and a point of contact for protocol questions once the study is running.

  • Central safety reporting

    A single route for reporting adverse events, with defined timelines and central handling — so that safety information from every site reaches the sponsor and the FDA consistently rather than site by site.

  • Data infrastructure

    A study data system for case report forms and source documentation, maintained centrally, with monitoring against the protocol so that data quality issues are caught during the study rather than after it. Placeholder, information still required: [TODO: confirm with MDRing — the specific EDC platform and monitoring arrangements.]

  • Product documentation with every shipment

    Cellenkos supplies release documentation with each batch, including testing confirming the identity, purity and activity of the cells, and a report of cell viability after thaw. Placeholder, information still required: [TODO: confirm with Cellenkos — the exact documentation set supplied to investigational sites.]

  • A patient registry

    Enrolment into a registry that follows participants' outcomes over time, alongside and distinct from the study's own case report forms. Placeholder, information still required: [TODO: confirm with MDRing — registry scope, who holds it, and how it relates to study data.]

Tell us about your practice

Sites are being evaluated now, market by market. If your practice sees these patients and could support a regulated study, start with a short enquiry and we will follow up about fit.

Become a Study Site