Which Biologic Treatments Does Dr. Raffo Actually Use?
A surgeon's account of which biologic treatments hold up in trials, which he offers, which he declines to offer, and why the honest answer is narrower than the marketing around regenerative medicine.
Overview
Biologics are treatments made from a patient's own blood, marrow, or tissue — platelet-rich plasma (PRP), bone marrow aspirate concentrate (BMAC), and bioinductive implants like Regeneten. None of them regenerate cartilage or reverse arthritis, and Dr. Raffo does not offer several biologic products marketed elsewhere in the region because the trial evidence does not support them. This page states plainly what he uses, what he declines, and why.
Who this is for
This page is for patients considering an injection or an add-on biologic before or during surgery, and for anyone who has seen "regenerative medicine" marketing and wants a straight answer about whether it applies to their situation. It is relevant to shoulder tendinopathy, knee osteoarthritis, and biologic augmentation offered alongside rotator cuff repair or meniscal repair. It is not a substitute for cartilage restoration surgery, and it is not a treatment path for patients with advanced, bone-on-bone arthritis — no biologic on this page changes that picture.
How I approach it
I use biologics selectively, and I turn down more requests for them than I grant. Patients often arrive having read that PRP or stem cell injections can regenerate a joint, and my first job is to correct that before we talk about anything else. PRP has a real, reproducible role in a handful of conditions and a much weaker one in others, and I try to be as clear about the second group as I am enthusiastic about the first.
The clearest example of where I've drawn a line is knee osteoarthritis PRP for cartilage restoration. The RESTORE trial — a 288-patient, placebo-controlled RCT published in JAMA — found that a single PRP injection produced no difference in medial tibial cartilage volume on MRI at 12 months compared with saline, even though it did produce a modest pain benefit (Bennell et al., JAMA 2021). I tell patients that result directly: PRP is not going to rebuild their cartilage, and anyone who tells them otherwise is overselling the product. The same honesty applies to cuff tendinopathy. A double-blind RCT of PRP versus saline for chronic rotator cuff tendinopathy found no statistically significant advantage at any time point out to a year (Kesikburun et al., AJSM 2013). I still use PRP in other, better-supported settings — I describe where on the dedicated PRP page — but I don't pretend a negative trial doesn't exist because it's inconvenient.
I've also declined to bring several biologic products into my practice that are marketed regionally as "stem cell therapy." That term gets used loosely for things that are not stem cell transplants at all. What I do use, in a narrow surgical context, is bone marrow aspirate concentrate (BMAC) — a concentrate of a patient's own bone marrow cells drawn and spun down in the same setting, not a laboratory-grown or donor stem cell product. I explain exactly what BMAC is and is not on the surgical augmentation page, because the imprecision around this term is itself a source of patient harm.
Where Surgeons Disagree
Should PRP be offered as a standalone treatment for knee osteoarthritis pain?
I offer it selectively, for patients with mild-to-moderate osteoarthritis who understand it is a symptom treatment, not a structural one, and I decline it for patients seeking cartilage restoration.
A meta-analysis of 10 RCTs found PRP statistically superior to hyaluronic acid on pain and function at both 6 and 12 months (Dai et al., Arthroscopy 2017), and a further meta-analysis found similar pain and function benefit (Shen et al., AJSM 2017). But the RESTORE RCT — the most rigorous placebo-controlled trial in this space — found no cartilage-volume benefit over saline at 12 months, only a modest pain effect (Bennell et al., JAMA 2021). Those two facts have to sit side by side: PRP can help pain in the right patient, and it does not regenerate the joint.
Where I’d be talked out of it
In a patient with advanced, bone-on-bone osteoarthritis who is hoping an injection will delay or avoid a knee replacement, I won't offer PRP as that delay strategy. The evidence base is built on mild-to-moderate disease, and using it as a substitute for a conversation about arthroplasty in an end-stage joint sets up a patient to be disappointed and to lose time.
Is bone marrow aspirate concentrate (BMAC) worth adding to a rotator cuff repair?
I don't add BMAC to a routine cuff repair. I discuss it selectively for a large tear in a patient with reduced healing potential, and I am explicit that the data do not show it improves how the patient feels.
In a randomized trial of concentrated bone marrow aspirate added to rotator cuff repair, the structural retear rate was markedly lower with BMAC — 18% versus 57% on Sugaya grading, a highly significant difference — but clinical failure rates were nearly identical (16% versus 15%), and patient-reported outcome scores did not differ between groups (Cole et al., AJSM 2023). BMAC changed the MRI picture without changing how the patient did. That is not nothing — a structurally healed tendon may hold up better over the following decade — but it is not the same claim the term "stem cell repair" tends to imply.
Where I’d be talked out of it
In a younger patient with a large or massive tear and reasonable tissue quality, where the added healing signal has more years to matter and the patient understands the current evidence gap, I will discuss BMAC as a reasonable adjunct. I present it as a plausible structural insurance policy, not as a proven functional upgrade.
Risks and honest tradeoffs
PRP and BMAC are both derived from the patient's own blood or marrow, so the risk of an immune reaction or disease transmission is essentially eliminated compared with a donor-tissue product. The realistic risks are procedural: injection-site soreness and a temporary flare of symptoms for a few days, a small infection risk from any needle placed near a joint or tendon, and, for BMAC, the discomfort and minor bleeding risk of a marrow aspiration, usually taken from the iliac crest at the time of surgery. The larger risk with biologics generally is not physical — it is financial and expectational. Most PRP and BMAC preparations are classified as investigational by commercial insurers, Medicare, and Medicaid, which means the cost is typically an out-of-pocket expense rather than a covered service, and patients considering these treatments should ask directly what is and is not covered before proceeding. None of these treatments carry a guarantee, and none of them are appropriate substitutes for a joint replacement in end-stage arthritis.
Alternatives I considered
For patients whose main goal is pain relief in a mildly or moderately arthritic joint, a corticosteroid injection remains a reasonable first step — faster acting than PRP, less expensive, and typically covered by insurance, even though its benefit fades faster over time than PRP's does in some studies. For patients hoping a biologic will substitute for a structural operation — a torn tendon that needs to be reattached, or a joint that needs to be replaced — I don't present PRP or BMAC as a genuine alternative, because neither one repairs a structural problem that requires mechanical fixation.
Biologics used
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Appointments are booked through Maryland Orthopedic Specialists, where Dr. Raffo practices.
Frequently Asked Questions
Clinical References
- Bennell KL, Paterson KL, Metcalf BR, et al. Effect of intra-articular platelet-rich plasma vs placebo injection on pain and medial tibial cartilage volume in patients with knee osteoarthritis: the RESTORE randomized clinical trial. JAMA. 2021;326(20):2021-2030.
- Kesikburun S, Tan AK, Yilmaz B, Yaşar E, Yazicioğlu K. Platelet-rich plasma injections in the treatment of chronic rotator cuff tendinopathy: a randomized controlled trial with 1-year follow-up. Am J Sports Med. 2013;41(11):2609-2616.
- Dai WL, Zhou AG, Zhang H, Zhang J. Efficacy of platelet-rich plasma in the treatment of knee osteoarthritis: a meta-analysis of randomized controlled trials. Arthroscopy. 2017;33(3):659-670.
- Shen L, Yuan T, Chen S, et al. The temporal effect of platelet-rich plasma on pain and physical function in the treatment of knee osteoarthritis: systematic review and meta-analysis of randomized controlled trials. Am J Sports Med. 2017;45(11):2708-2719.
- Cole BJ, et al. Concentrated bone marrow aspirate augmentation of rotator cuff repair: randomized controlled trial. Am J Sports Med. 2023.
Related Procedures
Platelet-Rich Plasma (PRP)
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How Dr. Raffo decides whether to add Regeneten, PRP, marrow venting, or BMAC at the time of rotator cuff or meniscal repair, and why he doesn't add one by default just because it's available.
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