### Clarifying the Misconception on Penis Transplants

 

It's a common myth that the penis cannot be transplanted, but that's not accurate based on medical advancements. Since 2006, at least five successful penis transplants (also called penile allotransplants) have been performed worldwide, primarily for patients with severe trauma, cancer, or congenital conditions. These are vascularized composite allografts, meaning they transfer skin, nerves, blood vessels, muscles, and erectile tissues from a deceased donor. Key examples include: - **2006 (China)**: First attempt, but explanted after 15 days due to psychological issues, not medical failure. - **2014 (South Africa)**: Successful; the patient achieved erectile function and fathered a child within months. - **2016 (USA, Massachusetts General Hospital)**: Restored urinary and sexual function. - **2017 (South Africa)**: Another success with long-term sensation and erection. - **2018 (USA, Johns Hopkins)**: World's first total penis and scrotum transplant on a wounded veteran; the patient regained near-normal urinary and sexual functions after 14 hours of surgery, with immunosuppression to prevent rejection. Outcomes are mixed—two transplants were removed due to complications like rejection or infection—but long-term successes show restoration of sensation, urination, and erection when patients adhere to immunosuppressive therapy. Programs like Johns Hopkins' continue screening candidates (e.g., cisgender men with trauma-related loss), but it's not routine or available for gender-affirming care yet. Risks include lifelong meds, infection, and psychological challenges, so it's reserved for severe cases. ### Stem Cell Organ Regeneration for the Penis (According to Your DNA) Stem cell therapy is a promising frontier for regenerating penile tissue, especially erectile components like the corpora cavernosa (spongy erectile tissue), without relying on donors. This aligns with your idea of "according to your DNA"—most approaches use **autologous stem cells** (from your own body, e.g., adipose-derived or bone marrow-derived mesenchymal stem cells, or ADSCs/BM-MSCs) to avoid rejection. The cells are harvested, expanded in a lab, and injected into the penis to promote repair. Here's how it works and the progress: #### Mechanism - **Tissue Regeneration**: Stem cells differentiate into smooth muscle cells, endothelial cells (for blood vessels), and nerves essential for erections. They repair damage from diabetes, injury, or aging by rebuilding vascular networks and reducing fibrosis (scarring). - **Paracrine Effects**: Cells release growth factors (e.g., VEGF for new blood vessels) and anti-inflammatory signals, improving blood flow and erectile function without fully replacing tissue. - **DNA Match**: Since cells are your own, the regenerated tissue integrates seamlessly, matching your genetics. Emerging techniques use decellularized scaffolds (ECM from donor tissue stripped of DNA) seeded with your stem cells for full organ-like regeneration. #### Current Progress (as of September 2025) Research is mostly preclinical (animal models) and early-phase human trials, focused on erectile dysfunction (ED) rather than total penis reconstruction. No full "organ" regeneration yet, but significant strides in functional repair: | Study/Approach | Key Findings | Stage | Year | |---------------|--------------|-------|------| | **ADSC Injections for Diabetic ED** (Iranian RCT, n=21) | Intracavernous injection of 50-60 million oral mucosa-derived stem cells improved sexual function (IIEF score), penile artery blood flow (PSV/RI indices), and tissue regeneration; no side effects. | Phase II Human Trial | 2021 | | **UC-MSC for Type 1 Diabetic ED** (Rat Model) | Umbilical cord MSCs restored intracavernous pressure, increased smooth muscle-to-collagen ratio in penile tissue, and enhanced erectile function via paracrine signaling. | Preclinical | 2024 | | **MDSC-Seeded Scaffolds** (Rabbit Model) | Muscle-derived stem cells on acellular corporal matrices reconstituted functional corpus cavernosum in vivo, with vascularization and erectile tissue formation. | Preclinical | 2024 | | **Combination Therapy (Li-ESWT + BMSCs)** | Low-intensity shockwave + bone marrow stem cells regenerated penile tissue, boosted blood flow, and improved erections more than shockwave alone. | Preclinical/Human Pilot | 2021 | | **Human Penile Decellularization** | Full penis scaffold created by removing cells/DNA; ready for seeding with patient stem cells to engineer composite tissue. | Preclinical (Proof-of-Concept) | 2019 | - **Human Trials**: About 3-5 small trials (e.g., post-prostatectomy ED) show 50-70% improvement in erectile function scores, with sustained benefits up to 12 months. No large RCTs yet; FDA/EU approvals pending for wider use. - **Challenges**: Optimizing cell dosing, ensuring long-term engraftment, and scaling for full regeneration. It's minimally invasive (outpatient injections) but not a "cure-all"—best for mild-moderate ED. - **Future**: By 2030, experts predict Phase III trials for ED; full penis regeneration (e.g., for trauma) could follow with bioprinting + stem cells. This is safer than transplants (no immunosuppression) and truly personalized via your DNA. ### What is Foregen? Their Work and Progress I believe "Foregene" is a reference to **Foregen**, a nonprofit (founded 2010) dedicated to regenerating the **foreskin** (the retractable skin covering the penis head) for circumcised men using tissue engineering. Circumcision removes this sensitive tissue, and Foregen aims to reverse it non-surgically by regrowing functional foreskin. (If you meant a different "Foregene," like a gene or company, clarify!) #### Their Approach - **Patient-Specific Regeneration**: Donor foreskin is decellularized (cells/DNA removed, leaving a scaffold/ECM). Your stem cells (autologous, per your DNA) are seeded onto it, grown in a bioreactor, and implanted as a thin sleeve around the penis shaft. This restores nerves, ridged band, and frenulum for natural sensation/protection. - **Why?** Unlike stretching/tugging (non-regenerative), this rebuilds the exact tissue architecture. #### Progress (as of September 2025) Foregen's roadmap has four milestones; they're in late preclinical stages, funded by ~$100K+ in donations. Human trials were hoped for mid-2025 but delayed due to ethics/regulatory hurdles—now targeting 2026-2027. | Milestone | Description | Status | |-----------|-------------|--------| | **1: Proof-of-Concept** | Decellularized rabbit/human foreskin ECM created; compatible with stem cells. | Completed (2015-2020) | | **2: Decellularization** | Processed 41 human foreskin samples in Slovakia; ECM preserves structure for seeding. | Completed (July 2025) | | **3: Recellularization & Testing** | Seeded ECM with fibroblasts/MSCs; biomechanical tests confirm elasticity/sensation potential. | Completed (September 2025) | | **4: Bioreactor & Trials** | Scale-up growth; FDA/EU submissions for Phase I safety trial (10-20 men). Lab tour video released showing facilities. | In Progress (Q4 2025); Institutional funding sought. | - **Recent Wins**: $52K raised in July 2025 (doubled via matching); key study on decellularization accepted for publication. No adverse events in animal models. - **Timeline**: Preclinical wrap-up by end-2025; trials in 2026 if funded/approved. Cost: ~$20K-50K per procedure (estimated, post-trial). - **Caveats**: Some staff left in early 2025 for a spin-off (Akroprint), but core team (e.g., Dr. Stanislav Žiaran) remains. It's elective/cosmetic, so not fast-tracked like life-saving therapies. Foregen's work complements broader stem cell penile regeneration—focusing on foreskin but using similar tech. For transplants or ED trials, consult a urologist; for Foregen, sign up on their site for updates. If this isn't what you meant by "Foregene," or you want sources/details on a specific part, let me know!