IN SHORT
Placental and amniotic products are made from birth tissues donated after a healthy delivery, such as the amniotic membrane and amniotic fluid. Some membrane products are legally used as wound coverings, but injectable amniotic or placental ‘stem cell’ products for joints, pain or disease are not FDA-approved.
What is placental & amniotic stem cell products?
The placenta and the amniotic sac surround the baby in the womb. After birth, these tissues can be donated and processed. Products include dried membrane sheets, ground-up tissue and amniotic fluid suspensions. Many are marketed as ‘stem cell’ treatments, although processing often leaves few or no living cells.
How it works
Donated tissue is cleaned, screened, and then dried, frozen or ground into a powder or liquid. Membrane sheets are placed over wounds or used in eye and surgical procedures. Injectable versions are thawed or mixed and injected into joints, tendons or the spine, or occasionally given by IV. Any effect is thought to come from growth factors and proteins rather than living stem cells.
Legal status
In the US, amniotic membrane used as a barrier or covering, such as on a wound, can fall under the lighter Section 361 tissue rules. Using amniotic or placental material to treat arthritis or other diseases is generally not ‘homologous use’, so these products are regulated as drugs or biologics (Section 351) and need FDA approval; none is approved for these uses.
The FDA has issued warning letters to firms selling such injectables and lists amniotic fluid among unapproved products. In the EU, cell-based placental products used therapeutically fall under advanced therapy rules.
What the evidence shows
Amniotic membrane has a long history in wound and eye care, with supportive evidence for some chronic wounds. For knee arthritis, a 2026 meta-analysis of five small studies (262 patients) reported improved scores after amniotic suspension injections, but it pooled case series without strong placebo control.
A 2026 narrative review called amniotic biologics ‘promising’ but stressed the need for rigorous randomised trials and standard product definitions. There is no good human evidence for injections in neurological, lung or anti-ageing uses. Results from one product cannot be applied to another, because processing varies widely.
Commonly marketed for
- Knee and hip arthritis
- Tendon and ligament injuries
- Plantar fasciitis
- Back and neck pain
- Chronic wounds
- Hair loss and cosmetic skin treatments
Cost
Typical price range: $1,150 – $12,000. A 2017 survey of 317 US clinics found stem cell knee injections, including donor birth-tissue products, cost $1,150 to $12,000 (average $5,156). Insurance may cover some approved wound-care uses of amniotic membrane but not injections for arthritis or pain.
Risks
- Infection from contaminated or poorly screened donor tissue
- Pain, swelling or inflammation after injection
- Immune or allergic reactions
- Variable and unknown product content
- Paying for ‘stem cells’ that contain no living cells
Questions to ask first
- Is this product being used as a covering (as intended) or injected to treat a disease?
- Does it contain living cells, and can you show independent lab results?
- Which tissue bank supplied it, and how were donors screened?
- What randomised trial evidence supports using it for my condition?
Before You Pay: The Stem Cell Clinic Checklist
- 20 questions every legitimate clinic should answer in writing
- A red-flag scorecard to spot unregulated marketing
- Realistic 2026 cost ranges: US, Mexico, Panama & Europe
- How to find a registered clinical trial
Placental & Amniotic Stem Cell Products: FAQs
Do amniotic injections contain stem cells?
Often very few or none. Processing such as drying, freezing or sterilising tends to kill cells, so effects are usually attributed to proteins and growth factors.
Is amniotic tissue legal to use?
Amniotic membrane used to cover wounds or in eye surgery can be legal under tissue rules. Injecting amniotic products to treat arthritis or disease requires FDA approval, which none has.
Is it ethical? Does it harm the baby?
Tissue is collected after a healthy birth with the mother’s consent. It does not involve embryos or harm the baby.
Do amniotic injections work for knee arthritis?
Small studies report improved scores, but high-quality, placebo-controlled evidence is lacking. Products differ, so results do not transfer between brands.
What are warning signs at a clinic?
Claims of ‘FDA-registered’ as if it meant approved, promises of regrowing cartilage, and pressure to pay for packages up front are common red flags.
Related guides
- IV Stem Cell Therapy
- Mesenchymal Stem Cells (MSCs)
- Umbilical Cord Stem Cells
- Exosome Therapy
- PRP vs Stem Cells
- All treatment types · Glossary
Sources
- FDA: Important patient and consumer information about regenerative medicine therapies
- FDA: Regulatory considerations for HCT/Ps — minimal manipulation and homologous use (2017 guidance)
- Efficacy of intra-articular human amniotic suspension allografts for knee OA: systematic review and meta-analysis (2026)
- Amniotic biologics for knee osteoarthritis: promise, evidence, and unmet needs (Biomedicines, 2026)
- EMA warns against using unproven cell-based therapies (2020)
- ISSCR Guide to Stem Cell Treatments
- Stem cell centers on the rise (AAOS cost survey)
Last reviewed October 2026. For general information only — not medical advice. We do not endorse any clinic or product. Always consult a qualified, licensed healthcare professional. See our medical disclaimer and editorial policy.