Procedure Description:
Stem cell therapy is a form of regenerative medicine that uses the body’s own healing cells to repair and regenerate damaged tissues. Stem cells are undifferentiated cells with the ability to develop into various specialized cell types and release signaling molecules that reduce inflammation, stimulate tissue growth, and support healing. The therapy is typically performed via targeted injections into joints, tendons, ligaments, or discs to treat musculoskeletal conditions.
Types of Stem Cells & Harvest Locations:
Stem cells used in orthopedic and pain medicine are usually adult (autologous) mesenchymal stem cells (MSCs) harvested from the patient’s own body. The most common sources include:
Bone Marrow-Derived Stem Cells (BMAC)
Harvested from the posterior iliac crest (hip bone)
Rich in MSCs and hematopoietic cells
Adipose (Fat)-Derived Stem Cells
Collected via mini-liposuction, typically from the abdomen or flanks
Abundant in stromal vascular fraction (SVF), which contains regenerative cells
Note: Embryonic and perinatal stem cells (e.g., umbilical cord, placenta) are restricted by U.S. regulatory agencies and are not used in compliant clinical settings without FDA authorization.
What It Treats:
Stem cell therapy is used to treat a variety of musculoskeletal and degenerative conditions, including:
Osteoarthritis (knee, hip, shoulder, ankle)
Degenerative disc disease
Tendon and ligament injuries (rotator cuff, Achilles, etc.)
Labral or meniscal tears (in early stages)
Non-healing fractures
Chronic joint pain or instability
Failed conservative treatments prior to surgery
How It Is Performed:
Harvesting
Bone Marrow: Aspirated from the pelvic bone under local anesthesia
Adipose Tissue: Harvested through a mini-liposuction procedure
Processing
The collected tissue is processed using a centrifuge or closed sterile system to isolate and concentrate the stem cells.
Injection
The stem cells are injected into the targeted area using ultrasound or fluoroscopic guidance for precision.
Total Time
The entire process usually takes 1–2 hours and is performed as an outpatient procedure.
Pre-Procedure Instructions:
Avoid NSAIDs (e.g., ibuprofen, naproxen) for 1 week before the procedure.
Stay well hydrated and eat a light meal prior to the appointment.
Disclose all medications, supplements, and medical conditions to your provider.
Arrange transportation if sedation or fat harvesting is being performed.
What to Expect After the Procedure:
Mild soreness or swelling at the injection or harvest site is common for several days.
Avoid strenuous activity or impact exercise for 1–2 weeks post-procedure.
Physical therapy may be recommended to support rehabilitation.
Do not take NSAIDs for at least 1–2 weeks post-injection.
Symptom improvement may begin within 4–8 weeks, with continued improvement for up to 6 months or more.
Legal and Regulatory Aspects in the USA (as of 2025):
✅ FDA-Compliant Use:
Autologous stem cell therapies (using your own cells) are permitted under the “same surgical procedure” exemption if:
The cells are minimally manipulated (e.g., centrifuged but not cultured or expanded)
Used during the same surgical procedure
Used for homologous purposes (consistent with their natural function)
🚫 Not FDA-Approved:
Expanded or cultured stem cells, or those derived from perinatal tissues (umbilical cord, placenta), are not FDA-approved for clinical use unless part of an Investigational New Drug (IND) trial.
Marketing or injecting off-the-shelf stem cell products from birth tissues is considered illegal without IND/BLA approval.
⚠️ Enforcement:
The FDA has issued numerous warning letters and injunctions to clinics promoting unapproved stem cell products.
Patients should verify that their treatment is performed in compliance with FDA guidelines.
PRP vs. Stem Cells: A Comparison
Aspect | Platelet-Rich Plasma (PRP) | Stem Cell Therapy (BMAC or Adipose) |
Source | Platelets from patient’s blood | Bone marrow or adipose tissue from patient |
Cell Content | No live cells, just growth factors | Contains living regenerative cells + signaling factors |
Primary Action | Anti-inflammatory, promotes healing | Anti-inflammatory, tissue regeneration & cell repair |
Regulation | FDA-compliant for musculoskeletal use | Limited to same-day, autologous use under FDA rules |
Conditions Treated | Mild to moderate arthritis, tendonitis | Moderate to severe arthritis, disc disease, tissue damage |
Cost | Lower | Higher |
Onset of Relief | 2–6 weeks | 4–8 weeks |
Bottom Line: PRP is often effective for milder conditions or early intervention, while stem cell therapy may be more appropriate for moderate-to-severe degeneration or cases that failed PRP treatment.
Conclusion:
Stem cell therapy holds tremendous promise for healing and regenerating musculoskeletal tissues. While early results are encouraging, patients must be aware of legal boundaries, scientific limitations, and realistic expectations. Autologous stem cell treatments done in compliance with FDA guidelines are available and can be effective, especially when paired with a comprehensive treatment plan.
If you are considering stem cell therapy, speak with a qualified regenerative medicine specialist to explore your options and ensure you're receiving safe, evidence-based care.