Clinical Trial Eligibility

→ The active US OLT/ankle cartilage trial landscape is still very narrow, but it improved this month: the one trial that directly targets joint-preserving treatment for OLT now has a California site.

MASCOT (NCT06915233) — The Top Priority Trial

Vericel's Phase 3 RCT of MACI vs bone marrow stimulation for symptomatic chondral/osteochondral defects of the ankle. Trial record last updated July 23, 2026 [210]:

• Sponsor: Vericel Corporation
• Phase: Phase 3, randomized 2:1, n=309 target
• Status: Recruiting. Actual start date May 28, 2026; estimated primary completion July 2030
• Primary endpoint: FAOS Pain + Function (Sports & Recreation) at Week 104
• Eligibility: Age 17-65, ICRS grade 3-4 talar lesion “with or without cysts” (including talar neck/shoulder lesions), at least one lesion ≥1.2 cm², FAOS Pain and Function both ≤50
• Key exclusion 1: Underlying bony defect depth >5 mm. Raymond's recorded 10 mm cyst depth is the critical question — but note the inclusion criteria explicitly permit cysts, so this turns on the measured bony defect depth rather than on the presence of a cyst
• Re-verified July 29, 2026 — and inclusion 3 and exclusion 1 are in tension with each other. The entire criteria list was pulled from the registry API a second time and every criterion recorded on this page was confirmed verbatim, with no discrepancies. That re-reading surfaced something new. Inclusion 3 explicitly admits lesions “with or without cysts.” Exclusion 1 caps underlying bony defect depth at 5 mm. A Hepple V cystic lesion will commonly exceed 5 mm of subchondral involvement — so the protocol invites a lesion type that its own exclusion then screens out. “Cyst depth” and “underlying bony defect depth” are not self-evidently the same measurement, and this page has been treating them as though they were. Whether the recorded 10 mm is the operative number is a radiologist's measurement judgment. That converts this from a settled disqualification into a specific question to ask the UC Davis team and Vericel Clinical Affairs — how the protocol defines and measures that depth — before assuming the answer is no [210]
• Also confirmed as clearing: inclusion 4 requires at least one lesion ≥1.2 cm², and a 15 × 10 mm lesion is roughly 1.5 cm²; the age range of 17–65 also clears. So of the numeric criteria, only the bony-depth cap is in question
• Key exclusion 7: Lesions requiring an osteotomy to allow MACI implantation, determined at arthroscopy. This is a live risk for a medial dome lesion and is decided in the operating room, not beforehand
• Key exclusion 15 — a 90-day injection washout, and it interacts with the Supartz decision: the protocol excludes anyone who has had hyaluronic acid, PRP, or corticosteroid injected into the target ankle within 90 days before Visit 1. The Supartz injection was given May 18, 2026 (May 7 was the date the drug was purchased, not injected), so the window clears on August 16, 2026 and is not a lasting barrier. But a repeat HA series would restart the 90-day clock and push the earliest possible screening date out by three months from the last injection. These two decisions are not independent, and this page previously treated them as though they were
• Resolved — the prior allograft is not a bar. The full exclusion list was read directly from the trial record on July 28, 2026. A prior fresh osteochondral allograft is not an exclusion criterion. The only surgical-history exclusion is any surgery on the target joint within 24 weeks of Visit 1, explicitly excepting diagnostic ankle arthroscopy. A 2012 allograft is far outside that. This closes a question this page previously listed as unanswerable from the public record
• Other exclusions worth knowing: avascular necrosis of the ankle, kissing/bipolar or bilateral lesions, advanced ankle osteoarthritis (Kellgren-Lawrence 4 or Van Dijk III), systemic inflammatory joint disease, porcine or bovine hypersensitivity, current smoking at a pack a day or more, and HbA1c ≥8.0%
• Sites now recruiting (7): UC Davis Foot and Ankle Clinic, Sacramento CA — new, and the first California site; MedStar Georgetown, Washington DC; Elevate Clinical Research, Wichita KS; Duke Orthopaedic Surgery, Durham NC; Elevate Clinical Research, Houston TX; Rodaro LLC, San Antonio TX; University of Virginia, Charlottesville VA
• UC Davis contact (verified July 28, re-verified July 29, 2026): study coordinator Leslie Mellor, 916-826-8135, ljmellor@health.ucdavis.edu; principal investigator Eric Giza, MD
• Every site coordinator, pulled from the registry July 29, 2026 — all seven sites confirmed RECRUITING. Recorded so a second site can be approached directly if Sacramento screens him out on the depth measurement: MedStar Georgetown, Washington DC — Joshua Lawrence, 240-863-1681; Elevate Clinical Research, Wichita KS and Houston TX — Tara Bocquet, 832-225-2937; Duke, Durham NC — Suzanne Finley, 919-684-5431; Rodaro LLC, San Antonio TX — Carrisa Bolado, 210-689-8287; University of Virginia, Charlottesville — Eric McVey, 434-243-5382
• Action: Sacramento is drivable, which makes this a real option rather than a hypothetical. The remaining gate is a numeric one: get the current measured bony defect depth from recent imaging, because the recorded 10 mm sits twice the 5 mm cap. If that number comes back at or under 5 mm, contact the coordinator directly — the allograft history is no longer a reason to hesitate. Vericel Clinical Affairs (978-347-2876, clinicalhotline@vcel.com) remains useful for questions the record does not answer, but the allograft question is now settled

Updated August 1, 2026 — both remaining gates now turn on one radiology question

→ Two things changed this week. The depth number that this page treats as the disqualifier is contradicted by Raymond's own CT report, and a new consensus makes the kissing-lesion exclusion worth checking at the same time. Both are answered by one re-read of existing imaging.

• The 10 mm may not be the operative number, and the consensus says to measure it on CT. The April 2025 CT report reads “15 mm area of sclerosis of medial talar dome with several subchondral cysts measuring up to 4 mm,” and Dr. Choung, having reviewed both studies, said the CT cysts are small and that most of the signal is reactive bony inflammation. The 10 mm comes from Dr. Chawla's Cleveland Clinic remote records review, not from the radiologist who acquired the study. These are probably measuring different structures — the whole bony envelope versus the discrete cysts inside it — and neither is self-evidently what the protocol means by “underlying bony defect depth.” The 2018 consensus is unanimous that “if precise measurement is required including depth, the use of CT is recommended,” and holds that MRI tends to overestimate lesion size [304]. This does not mean he qualifies. It means the expected answer moved from “almost certainly no” to “genuinely open,” and that the question to ask is definitional as well as numeric
• Check the kissing-lesion exclusion in the same request. Exclusion criteria bar kissing or bipolar lesions. A consensus published July 31 names kissing lesions a top-four prognostic factor at 100% agreement and recommends managing them simultaneously with the talar lesion [302]. Nothing in Raymond's record states whether the tibial plafond has ever been assessed — the April 2025 CT notes only mild joint-space narrowing and osteophytes. So the same reading answers a prognosis question and a second eligibility question
• Know what the other arm means before consenting. MASCOT randomizes 2:1 to MACI or arthroscopic bone marrow stimulation. The consensus statement on marrow stimulation reads: “The ideal size guidelines… are lesions <10 mm in diameter, <100 mm² in area, and <5 mm in depth. Bone marrow stimulation is less likely to succeed when used as a sole treatment in a lesion 15 mm in diameter or greater” — 94% agreement, Grade A1 for both diameter and area, the strongest grading in the whole consensus series [303]. This lesion is 15 × 10 mm, or 150 mm² — at the diameter threshold and half again over the area threshold. There is roughly a one-in-three chance of randomizing to an operation that high-grade consensus says is unlikely to work at this size. Ask the coordinator what the withdrawal options are, and at what point the arm is revealed

Updated August 3, 2026 — the comparator arm now has a 2026 trial saying this lesion does not belong in it

→ Nothing about eligibility changed this week. What changed is how much weight the “what if I draw the other arm” question deserves.

Every criterion and every coordinator on this page was re-read against the registry this week and matches verbatim; nothing needed correcting. The trial did not move — its last update was posted July 23, outside the window — and it remains recruiting with all seven sites open and UC Davis still the only West Coast site. Next nearest is Wichita.

What is new is evidence about the bone marrow stimulation arm. A 2026 randomized controlled trial of an improved marrow-stimulation technique, n=56 with two-year follow-up, required lesions “smaller than 10 mm… smaller than 100 mm²… and… smaller than 5 mm” deep and excluded “large cystic OLTs… history of surgeries… in the same lower extremity” [318]. This lesion fails four of those criteria. Its own investigators wrote that lesions like this one “have a low success rate with BMS and generally require more aggressive treatments.” Two cohort studies from the same group add that medial cystic lesions do measurably worse than lateral ones after marrow stimulation, with only 51.6% reaching a meaningful sport-score improvement [320].

What to do with that at the screening call. It does not argue against enrolling. It argues for asking three specific questions before consenting: at what point is the arm revealed, what are the withdrawal options if he randomizes to marrow stimulation, and whether the investigators consider a 150 mm² cystic revision lesion appropriate for that arm given this literature. Roughly one in three enrollees gets it.

Added August 3, 2026 — the one trial written for exactly this lesion, and he is barred from it

A trial registered in Australia — ACTRN12624000412538p, “Efficacy of Viable Cartilage Allograft in talar osteochondral lesions,” at the Sydney Orthopaedic Foot and Ankle Research Institute — is the closest analogue anywhere to a study of this exact problem. Its exclusion criteria bar “revision procedures,” and he is definitionally a revision [338]. It has also sat “not yet recruiting” with ethics approval pending since April 2024, so it may never run. A New Zealand companion, ACTRN12619000688189p, excludes “previous ankle operation” and bipolar lesions, and its ethics have been “not yet submitted” for seven years.

→ Recorded because it is worth knowing that the trial designed around this lesion type excludes people who have already been operated on — which is the recurring structural problem on this whole site. Also worth recording: these are the first non-US registry identifiers on this page. Two registries previously written off as automation-blocked, the Australian one and the EU's, turned out to be reachable all along, so future sweeps cover them.

Added August 6, 2026 — what the trial actually asks of him, which this page had never read

→ Every previous sweep read MASCOT's eligibility criteria. Nobody read its study design. Doing that today changes what “trying for the trial” means: it is not a screening visit that might lead to surgery. It is surgery that decides the screening.

The trial record did not move this week — still RECRUITING, still last updated July 23, 2026, still seven sites with UC Davis the only West Coast one, and every criterion on this page re-verified verbatim against the API today with no discrepancies. What is new is the protocol description [376]:

• Eligibility is settled in the operating room, not before it. “All participants will have an index ankle arthroscopy within 8 weeks to further assess clinical trial eligibility… During the index ankle arthroscopy (Visit 2), participants will be further evaluated against entry criteria. Cartilage lesion size will be measured before randomization.” Exclusion 7 — lesions needing an osteotomy — is explicitly decided there too. So both of his live risks, the depth question and the osteotomy question, are adjudicated after he is already under anaesthetic. He can be excluded on the table, having had an arthroscopy and received no treatment
• The cartilage biopsy is taken before randomization. “All participants who meet the eligibility criteria… will have a cartilage biopsy taken prior to randomization to study treatment.” Tissue is harvested from his talus before he knows which arm he is in. Someone who then draws marrow stimulation has been biopsied for nothing
• The marrow-stimulation arm happens in that same operation — “Participants randomized to Bone Marrow Stimulation will undergo the procedure during the Visit 2 ankle arthroscopy.” This answers the question this page has been telling him to ask the coordinator. There is no window between learning the arm and receiving it: if he draws marrow stimulation, he wakes up having had it. The trial is open-label (masking: NONE), so the arm is not concealed afterwards — but the practical withdrawal option he was told to ask about does not exist for that arm
• The MACI arm is a second, open operation. “Participants assigned to the MACI treatment arm will return within 5 to 12 weeks of the Visit 2 ankle arthroscopy to undergo MACI implantation procedure via arthrotomy (Visit 3).” So MACI means two surgeries and an open arthrotomy; marrow stimulation means one arthroscopy. That asymmetry has never been on this page
• A question for Vericel that follows directly, and nobody has asked it. Vericel has had FDA approval for arthroscopic MACI delivery — MACI Arthro — since August 26, 2024, for knee defects up to 4 cm² [377]. MASCOT nonetheless specifies arthrotomy for the talus. Is arthroscopic delivery permitted under this protocol, or is arthrotomy mandatory — and if mandatory, does that make the osteotomy exclusion more likely to bite for a medial dome lesion? Add it to the email in action item 18

None of this argues against the trial. It is still the best-matched active option and the only one on the West Coast. It does mean the decision to screen is a decision to have an operation with a roughly one-in-three chance of receiving the arm that 2026 evidence says is unlikely to work at this lesion size — and that is a different question from “should I make a phone call.”

Added August 6, 2026 — two trials that do not exclude him, and why neither is a plan

→ The recurring structural problem on this site is that trials exclude people who have already been operated on, and exclude deep cystic lesions. These two do neither. Both are small and far away, so the value is in what they prove is possible, plus one email worth sending.

• NCT07555899 — Istituto Ortopedico Rizzoli, Bologna. The one trial whose entry criterion is the cyst itself. A scaffold enriched with bone-marrow-derived cells placed at the subchondral level with retrograde drilling; RECRUITING, n=20, posted April 29, 2026. Criteria pulled from the API and read in full: no depth cap, no prior-surgery exclusion, no revision exclusion, no cyst exclusion. Inclusion admits “chronic cystic subchondral lesions of the talus (Grade IIA according to the Giannini classification)” and “large chronic OCLs (Grade IIA)” [378]. Giannini chronic Stage IIA is a damaged articular surface, ≥1.5 cm² and >5 mm deep [386] — which is close to a description of this lesion, and would make the exact depth that disqualifies him from MASCOT the thing that qualifies him here. Held back deliberately: the trial's own text also says “with intact cartilage” of one admitted category, retrograde drilling is a technique built around preserving a cartilage roof he does not have, and the Giannini definition rests on a single source's table. This is one email to Antonio Mazzotti MD PhD (antonio.mazzotti@ior.it, +39 349 879 8863), not a claim of eligibility — and it is Italy, n=20
• Its only patient-specific gate is coronal alignment — “distal tibial articular angle < or > 10°, talar tilt > 8°, severe cavus or flatfoot.” That is precisely what the ~$65 standing alignment film in action item 17 measures. The film he has been deferring since July is now also a trial-eligibility document
• NCT06932380 — Drammen, Norway. The only trial anywhere that names prior surgery as a qualifier. Inclusion: “symptomatic osteochondral lesions of the ankle where conservative treatment or previous surgery has been unsatisfactory” [379]. Not actionable, and recorded as a counterexample rather than an option: it is a 10-patient pilot of a patient-specific metal implant (topic 19's category, not joint preservation), it excludes “patients unable to attend follow-ups due to distance”, it excludes tibial-side arthritic change, and although it reads RECRUITING its record has not been touched since April 29, 2025

Corrections to this page, August 6, 2026

• NCT07332182 is a knee trial, and this page could be read as saying otherwise. It is rendered above as “for the Treatment of Deep Osteochondral Lesion” with the ending dropped; the official title continues “…of the Knee Joint — OSTEOCONFIRM Study” and every criterion in it is knee-specific. Its value on this page is unchanged — it remains the only registry record anywhere that states how depth is measured, “from the original subchondral bone plate level”, which is exactly the convention to propose to Vericel. It is a precedent to cite, not a trial to join. Also worth recording: it is NOT_YET_RECRUITING and has never been updated since its first posting on 2026-01-12
• NCT05942430 has a second radiology gate this page never recorded. Alongside the tibial-side kissing-lesion exclusion, it excludes “combined with ipsilateral ankle arthritis with joint space narrowing” — and the April 2025 CT notes mild joint-space narrowing. Academic while the record remains stale since 2023, but it is a third trial now turning on the same unread imaging
• Stop trying to answer the MASCOT depth question from registries. The full record was grepped for central, reader, core lab, adjudicat, radiolog, imaging and CT: every one returns zero except a match on “centralContacts.” The registry does not name the modality, the reference level, or an adjudicator — the only criterion in the entire protocol with a stated adjudicator is exclusion 7, and it is site-based. This is provably a Vericel-in-writing question and cannot be closed by more registry work

Updated August 7, 2026 — the company has now said the word “enrolling” out loud

→ Nothing about eligibility moved. What is new is corroboration: the enrollment claim this page had inferred from a spend line in a securities filing is now a plain declarative sentence from the CEO, with a date attached.

• The trial record did not move again today. Re-pulled from the registry API 2026-08-07: RECRUITING, last updated 2026-07-23, the same seven sites, UC Davis still the only West Coast one.
• On the Q2 2026 earnings call, Vericel CEO Nick Colangelo said, verbatim: “Vericel also began enrolling patients in its MACI ankle MASCOT study during the second quarter.” [403] Until now, “actually enrolling” rested on the 10-Q’s attribution of research spend to “MACI MASCOT trial spend” [309] — an inference. This is a direct statement, and it adds a fact the registry does not carry: first patients entered in Q2 2026, i.e. by the end of June. On a 309-seat trial with seven sites, enrollment has been running for a month or more. The competitive-seat clock is not hypothetical.
• Nothing else on the ankle anywhere in the release or the call coverage. The 8-K earnings release was retrieved from SEC EDGAR and grepped in full: the ankle appears exactly once, in forward-looking boilerplate; MASCOT appears zero times; no enrollment count was given. The depth-adjudication question remains a Vericel-in-writing item — the correction above stands.

Closest Bay Area Site (Any Talus Trial)

Paragon 28 Patient Specific Talus Spacer Post-Approval Study (NCT05364606) [211]:

• Site: Redwood Orthopaedics, Santa Rosa, CA — PI Dr. Thomas Chang, DPM, 707-544-3400
• Indication: AVN of talus (NOT OLT) — Raymond likely doesn't qualify
• BUT: Dr. Chang is a recognized foot/ankle researcher; worth a call even if trial isn't a fit — he may know of other ankle cartilage trials or off-label options in the Bay Area

Total Talus Replacement Trials (Joint-Sacrificing)

• Restor3d PROCLAIM (NCT06311331): Post-approval study, OrthoCarolina Charlotte NC. Enrolling by invitation. AVN/large talar OCD indication [212]
• 3DTalar Registry (NCT03965143): University of Missouri. AVN only
• Paragon 28 SMART Total Talus IDE: FDA-approved Aug 2023 but no CT.gov registration as of April 2026
• All are joint-sacrificing — contradicts Raymond's stated preference for joint preservation

Future Trials to Watch

• 15-PGDH inhibitor: No human OA/cartilage trial identified; timing for any clinical joint study is unknown
• Hy2Care CartRevive: FDA IDE approved April 2025. First US patient expected early 2026. Knee only, no ankle expansion announced
• Stanford 15-PGDH lab (Helen Blau): Direct contact may yield information about future cartilage trial plans

Bay Area Academic Centers: Trial Status

• UCSF: No active OLT/ankle cartilage trial. Worth contacting Foot & Ankle service for off-trial expert consultation
• Stanford: Drs. Loretta Chou, Geoffrey Abrams publish on OLT but no active trial. Worth direct contact for unregistered studies or compassionate access
• UC Davis: Now the California MASCOT site (added to the trial record July 2026) — see above. This supersedes the earlier finding that no California center was enrolling
• Kaiser, Cedars-Sinai, Scripps, Hoag: No enrolling OLT trials identified

International Options (If Highly Motivated)

• NCT03347877: Autologous osteo-periosteal cylinder graft specifically for Hepple V OLT — Peking University Third Hospital, Beijing. Enrolling by invitation
• Amsterdam UMC (Dahmen / Kerkhoffs): World leaders in OLT research, deepest trial pipeline
• Ospedale Galeazzi, Italy: AMIC for talus trial (NCT03371121)

Corrected August 5, 2026 — the 5 mm depth cap is not an industry convention. It belongs to one class of product, and this page said the opposite yesterday

→ Yesterday this page concluded that the 5 mm bony-depth limit was a field-wide gate that would follow him from sponsor to sponsor, and that looking for a more permissive trial was therefore not a strategy. That was wrong. It was inferred from two trials that happened to agree. A systematic read of the registry says the number is a property of the device, not of the field.

What the systematic check found. 374 unique cartilage-repair trial records were pulled from ClinicalTrials.gov and every eligibility section scanned for a depth threshold in millimetres; 31 such clauses appeared across 30 trials, and each was read in full to confirm whether it was an inclusion or an exclusion. The caps run 2, 3, 4, 5, 6, 7 and 8 mm. Two are decisive:

• Vericel's own other trial does not use 5 mm. NCT03588975 — MACI in patients aged 10 to 17, sponsor Vericel Corporation, currently recruiting — includes “OCD lesions with a bone lesion depth of ≤6 mm and does not require a bone graft” [356]. The same company, the same cell therapy, a different number.
• Agili-C allows 8 mm. The pivotal IDE study NCT03299959 excludes only “Bony defect depth deeper than 8mm, according to baseline MRI/X-ray/arthroscopy” [357].

And two talar trials invert the rule entirely — they require depth. NCT06527482, autologous osteoperiosteal transplantation for severe OLT, admits “Hepple V OLT on the medial side of the talus or the diameter of the lesion ≥ 8 mm” — and its full exclusion list contains no depth cap and no prior-surgery or revision exclusion at all [358]. NCT05942430, autologous costal osteochondral transplantation, requires “Hepple stage V talar osteochondral lesions with a lesion depth ≥5 mm” [359].

The principle, which is the part worth remembering: products that cannot fill bone — cell therapies and thin scaffolds — cap depth, because depth is what defeats them. Techniques that bring bone with them — osteoperiosteal grafts, costal osteochondral transfer, OATS, allograft — treat depth as the indication. A deep cystic lesion does not disqualify him from cartilage surgery in general. It disqualifies him from one family of it, and points at the family that has always been the more plausible fit for this ankle.

→ What this does not do is make him eligible for anything new. Both depth-requiring trials are in China — Beijing and Guangzhou — and neither registry record has been touched since August 2024 and September 2023 respectively, so their “recruiting” status is not trustworthy. Nothing here changes what he can enrol in. What it changes is the sentence he carries into the next consultation: not “my lesion is too deep for cartilage repair,” but “my lesion is too deep for the cell-therapy family, so which bone-carrying option fits it?”

One more thing NCT05942430 quietly confirms. Its inclusion also requires “Unilateral talar osteochondral lesions without corresponding lesions on the tibial side” — the kissing-lesion question already open as part of action item 11. That is now the second trial whose eligibility turns on a radiology question nobody has yet been asked to answer.

What survives from the August 4 entry, and it is the useful half. NCT07332182 studies an osteochondral scaffold, is titled “for the Treatment of Deep Osteochondral Lesion,” and still stops at 5 mm — and its exclusion 5 remains the only place in any registry record that states how the depth is measured: “according to baseline MRI, measured from the original subchondral bone plate level” [352]. That definition is still the right thing to put to Vericel in writing. Only the generalisation drawn from it was wrong.

Added August 4, 2026 — the registry sweep is now complete, and nothing new admits him

Two registries that four previous sweeps recorded as unreachable blind spots — jRCT in Japan and ChiCTR in China — were opened and searched this week. Neither holds an in-window record relevant to this lesion, and both negatives carry positive controls proving the searches worked [353]. CTIS, the European registry, was also called correctly for the first time; its four previously recorded zeros were artifacts of a malformed request. Across all of Europe there is exactly one in-window cartilage trial, and it is knee-only [354].

MASCOT did not move. Its record was last updated July 23, outside the window; it remains recruiting with the same seven sites and UC Davis still the only West Coast option. Every criterion and every coordinator on this page was re-read against the registry and matches exactly. One reframing worth carrying to the screening call: MASCOT has no exclusion for a failed prior cartilage procedure, and its only surgical-timing criterion is a 24-week lookback. A twelve-year-old allograft is therefore entirely neutral to the protocol — he does not read as a treatment failure to this trial, he reads as an ordinary candidate whose gating is anatomic rather than historical.

Recommended Next Steps

1. Call Vericel at 978-347-2876 to clarify MASCOT eligibility — and now ask specifically whether bony defect depth is measured from the original subchondral bone plate level on MRI, the convention NCT07332182 states explicitly [352]
2. If MASCOT doesn't fit, contact Stanford or UCSF Foot & Ankle for off-trial expert consultation
3. Call Dr. Thomas Chang at Redwood Orthopaedics (707-544-3400) for Bay Area trial knowledge
4. Set up CT.gov email alerts for "osteochondral talus," "MACI ankle," "ankle cartilage," "talus cartilage"
5. Contact Epirium Bio for MF-300 cartilage trial timing (long shot but worth a note)