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How Does Stem Cell Therapy Work and What Are the Risks?

How Does Stem Cell Therapy Work and What Are the Risks?

Greice Murphy
Healthcare Executive & CEO, Miami Stem Cell®
5 min read

Table of Contents

The stem cell therapy procedure usually has five parts: a consultation, a diagnosis with imaging, a treatment plan, a short in-office injection or IV infusion, and a recovery period with follow-up. The treatment itself often takes under an hour for an injection. Results develop gradually over weeks to months and are not guaranteed.

At a glance

  • Where it happens: in a doctor’s office, not a hospital stay
  • Anesthesia: usually a local numbing medicine, not general anesthesia
  • Time in clinic: often under an hour for an injection, longer if bone marrow collection or an IV is involved
  • Downtime: many people resume light activity quickly, with strenuous activity limited for a period
  • When results show: gradually, over weeks to months, and responses vary
  • Cost and insurance: usually self-pay for orthopedic uses
  • Florida law: physicians may offer certain unapproved stem cell therapies for orthopedics, wound care, and pain management under conditions explained below

Have questions about your own situation? Book a free 15-minute consultation or call (305) 598-7777. No pressure, no obligation.

If you are thinking about stem cell therapy in Florida, the first thing you probably want to know is simple: what actually happens to me?

Will it hurt? Will you be put to sleep? How long will you be at the clinic? Do you need someone to drive you home? Can you walk out and go back to your day, or do you need to rest for a week?

Those are sensible questions, and good clinics welcome them. A treatment that feels mysterious is a treatment people are afraid of. This guide removes the mystery. It walks through the stem cell therapy procedure in the order things really happen, explains what Florida law says, and shows you what to ask before you decide.

A note before we begin. “Stem cell therapy” covers several different approaches, and the details vary by clinic, by the type of cells used, and by the part of the body being treated. We explain the common variations so you know what to expect, but your own plan will come from your physician after a personal evaluation. Nothing here is medical advice.

What Is the Stem Cell Therapy Procedure?

The stem cell therapy procedure is an in-office treatment in which a physician delivers cells, or the signals those cells release, into a joint, tissue, or vein. The goal is to support the body’s natural repair processes and calm inflammation. It usually follows a consultation, imaging, and a personalized plan.

That definition is deliberately careful. These treatments are studied for their ability to support healing, not proven to cure disease, and they are discussed in detail in the sections on regulation and research below.

Stem cell therapy is an umbrella term. In orthopedic and pain care, you may hear about:

  • Mesenchymal stem cells (MSCs). Often sourced from donated umbilical cord tissue (Wharton’s jelly). Our guide to what mesenchymal stem cells are explains them in plain language.
  • Bone marrow aspirate concentrate (BMAC). Cells from your own bone marrow, usually from the hip bone. This is an autologous approach.
  • Platelet-rich plasma (PRP). Made from your own blood. Not technically a stem cell treatment, but often discussed alongside one. See PRP therapy.
  • Alpha-2-macroglobulin (A2M). A protein from your own blood. Read how A2M injections work.
  • Exosomes. Tiny signaling packages released by cells. See our exosome therapy guide.
  • Muse cells. A rare cell type under study. Learn more on our Muse cells page.

Each approach changes a few details. Using your own bone marrow adds a collection step. Using donated cord tissue does not.

How Does the Stem Cell Therapy Procedure Work Step by Step?

Here is the whole journey in one list. The sections that follow explain each step.

  1. Consultation. You discuss symptoms, history, and goals with a physician.
  2. Diagnosis and imaging. Exam plus X-ray, MRI, or ultrasound confirms the source of the problem.
  3. Treatment plan. You and your doctor choose the type of treatment, the area, and the cost.
  4. Preparation. You follow medication and activity instructions before treatment day.
  5. Check-in and consent. You review risks and sign consent forms.
  6. Collection, if needed. Your own bone marrow or blood may be collected and processed.
  7. Injection or infusion. The product is delivered into the target area or through an IV.
  8. Aftercare. You rest, limit activity for a time, and watch for warning signs.
  9. Follow-up and rehab. Results develop gradually, and many patients pair treatment with physical therapy.

Step 1: The Initial Consultation

Every responsible stem cell procedure begins with a conversation, not a needle.

At a first consultation, a physician will usually ask about your symptoms, how long you have had them, what you have already tried (physical therapy, medications, braces, injections), your medical history, your medications and supplements, and your goals. This visit is also your chance to ask questions.

Many clinics, including ours, offer a free 15-minute consultation so you can learn about your options before committing to anything. To see exactly what that conversation looks like, read about what to expect at a stem cell consultation in Miami.

What a good consultation should feel like: unhurried, honest, and focused on you. If you feel pushed to book on the spot, that is a warning sign. You should leave knowing whether you are a reasonable candidate, what is being proposed, and what your alternatives are.

Step 2: Diagnosis and Imaging

Before any treatment, your physician needs to know exactly what is causing your pain. This step matters more than most patients realize.

Physical examination. The doctor checks your range of motion, strength, stability, and the precise spot where it hurts. Sometimes pain in one area comes from another. A sore knee may be a hip issue, or shoulder pain may start in the neck.

Imaging review. X-rays show bone changes and joint space. MRI shows cartilage, tendons, ligaments, and discs in more detail. Ultrasound can show soft tissue and fluid. Bring any recent scans with you.

Why does this matter? Because the treatment is meant to be placed where the problem is. If the diagnosis is wrong, even a perfectly performed procedure will not help. This is also where your doctor decides whether regenerative therapy fits at all, or whether you need a surgeon or a different type of care.

Step 3: Choosing the Type of Treatment

Once the diagnosis is clear, you and your physician decide what makes sense. The choice depends on:

You may also hear options combined, such as PRP, A2M, or exosomes alongside cell-based treatment. Our article on stem cell therapy vs. PRP explains the differences.

By the end of this step you should have a clear plan, a quoted cost, and a list of risks, so nothing on treatment day is a surprise.

Step 4: How Do You Prepare for the Procedure?

Preparation is usually simple, but it matters. Always follow your own clinic’s instructions rather than a general list. Common themes include:

  • Medications. Some clinics ask patients to pause certain anti-inflammatory drugs (NSAIDs) before treatment. Never stop a prescribed blood thinner or any other prescription on your own. Any change should be coordinated with the doctor who prescribed it.
  • Supplements. Fish oil and high-dose vitamin E, for example, can affect bleeding. Mention everything you take.
  • Recent steroid injections. A cortisone shot in the same joint shortly before treatment may need to wear off first.
  • Illness. If you develop a fever or any new infection, call the clinic. Treatment is usually postponed when an infection is present.
  • Eating and hydration. For simple injections, many clinics suggest eating normally and staying hydrated. Your clinic will tell you if anything different applies.
  • Practical planning. Arrange a ride home if advised, wear loose clothing, and plan lighter activity for the next few days.

For a fuller checklist, see our guide on how to prepare for stem cell therapy.

Step 5: What Happens on Treatment Day?

Check-in and paperwork. You confirm your information and review your history. A good consent process explains what is being done, the possible risks, and that these treatments are not FDA-approved for the conditions discussed. Under Florida’s stem cell law, physicians must obtain signed consent that describes potential benefits and risks. Read it carefully and ask questions before signing.

Final review with your doctor. The physician confirms the plan, reviews your imaging again, checks your vital signs, and asks whether anything has changed since your last visit.

Positioning. You are made comfortable on an exam table in the position that gives the best access to the treatment area, such as lying on your back for a knee, or face down or on your side for a hip or spine.

Step 6: What Happens During the Injection or Infusion?

This is the core of the procedure. The details depend on the treatment.

Direct joint or tissue injection

This is the most common approach for orthopedic problems, often called an intra-articular injection when it goes into a joint.

  1. Skin cleaning. An antiseptic is applied to reduce infection risk.
  2. Numbing. Many providers apply a local anesthetic. You may feel a small pinch and a brief sting.
  3. Guidance. Many clinicians use ultrasound or live X-ray (fluoroscopy) so they can watch the needle reach the right spot, especially in deeper joints like the hip and spine. Ask your provider how they guide their injections.
  4. Injection. The prepared product is slowly delivered. You may feel pressure or fullness, and sometimes a brief ache.
  5. Completion. The needle is removed and a small bandage is applied.

The injection itself often takes only a few minutes. The visit takes longer because of preparation and positioning.

Bone marrow aspirate collection (if your own cells are used)

  1. Positioning and numbing. You lie on your stomach or side, and the area over the back of your pelvic bone is numbed carefully.
  2. Collection. The physician inserts a needle into the bone and draws out a small amount of marrow. Many patients describe deep pressure or a brief pulling sensation rather than sharp pain, though experiences vary.
  3. Processing. The marrow is concentrated, often in a centrifuge, which takes some time while you wait.
  4. Injection. The concentrated product is injected into the treatment area.

For background, see how mesenchymal stem cells are harvested.

PRP or A2M (blood-based preparation)

A small amount of blood is drawn from your arm, like a routine blood test. It is spun in a centrifuge to concentrate the portion used for treatment, and the prepared product is injected the same visit.

IV infusion

  1. IV placement. A small catheter is placed in a vein in your arm.
  2. Infusion. The product is given slowly, usually over a period of time while you sit or recline.
  3. Monitoring. Staff check how you feel and your vital signs.
  4. Finish. The IV is removed and a bandage is applied.

Our page on IV stem cell options gives more detail. This approach deserves a careful conversation with your physician, since the FDA has not approved these products for the conditions they are often marketed for.

Want to know which of these would apply to you? Request your free consultation and the team will explain your specific procedure before you decide anything.

Step 7: What Happens Right After the Procedure?

Most clinics have you rest briefly rather than leaving immediately.

  • Observation. Staff may keep you for a short period to make sure you feel well, especially after an IV or bone marrow collection.
  • Early sensations. Soreness, pressure, tightness, or mild swelling is common as the numbing medicine wears off. Some people feel little at all.
  • Written instructions. You will receive aftercare directions covering what to do, what to avoid, which warning signs matter, and when follow-up is scheduled.
  • Getting home. Many people can leave on their own after a simple joint injection, but you may be advised not to drive after a hip or spine injection or any treatment involving sedation. If in doubt, bring someone.

Step 8: What Should You Do in the First Few Days?

The first days are about letting your body respond while avoiding things that might interfere. Follow your own clinic’s instructions, but common themes include:

  • Expect some soreness. A temporary flare of discomfort or swelling is common.
  • Rest, but keep gentle movement. Light walking often helps the joint avoid stiffening, while strenuous activity is limited. The exact rules depend on the area treated.
  • Ask about pain medicine. Some physicians ask patients to avoid certain anti-inflammatories for a period. Ask what you may take rather than guessing.
  • Protect the site. Keep it clean and dry as directed, and avoid pools, baths, and hot tubs until cleared.
  • Avoid heavy lifting and high-impact exercise until your physician says it is okay.

See our guides on what not to do after stem cell treatment and exercise after stem cell injections.

When should you call your doctor?

Call promptly if you notice fever or chills, increasing redness, warmth, or swelling at the site, pus or unusual drainage, severe or worsening pain, numbness or weakness, or shortness of breath, chest pain, or signs of an allergic reaction. In an emergency, call emergency services. You can also report a bad reaction to the FDA through its MedWatch program.

Step 9: What Happens in the Weeks and Months Afterward?

This is where patience matters, because stem cell therapy is not a quick fix.

  • Gradual change. Some people notice improvement within weeks, others take months, and some do not respond. The treatment aims to support healing and reduce inflammation over time. Our stem cell therapy recovery timeline walks through what patients often experience, and our article on how long results may last in the knee covers longer-term expectations.
  • Rehabilitation. Many physicians recommend pairing treatment with physical therapy or strengthening. Stronger muscles can take load off a joint.
  • Follow-up visits. You may return to assess pain, function, and range of motion.
  • Possible additional treatment. Not everyone needs a repeat session, but some do. See our article on whether you will still need medication afterward.
  • Honest expectations. Results differ from person to person, and no responsible clinic can guarantee an outcome. Read more in our guide to the stem cell therapy success rate.

How Long Does the Stem Cell Procedure Take?

For a simple joint injection, the visit often takes under an hour and the injection itself only minutes. Bone marrow collection or an IV infusion usually lengthens the visit to one to a few hours. Your clinic can give you an exact estimate for your own treatment.

Type of procedure What it involves Typical time in clinic*
Joint injection of prepared product Cleaning, numbing, guided injection Often under an hour including preparation
Bone marrow collection plus injection Marrow draw, processing, injection Often longer, commonly one to a few hours
PRP or A2M Blood draw, processing, injection Often under an hour to about an hour
IV infusion IV placement, slow infusion, monitoring Often one to a few hours

*General estimates, not promises. Your clinic will give you the schedule for your own treatment.

Does the Stem Cell Procedure Hurt?

For most people the discomfort is modest and short-lived. A local anesthetic numbs the skin, and the injection is usually quick. Many people describe pressure or a brief ache rather than sharp pain. A bone marrow collection often feels more intense, and mild soreness afterward is common.

Pain tolerance varies. If you are nervous about needles, tell your provider. Good clinics will explain what to expect and may offer options to help you stay comfortable.

What Are the Risks and Side Effects?

No medical procedure is risk-free, and a trustworthy provider will say so plainly. Possible risks of injection-based procedures include:

  • Pain, swelling, or stiffness at the site (the most common, usually temporary)
  • Bleeding or bruising
  • Infection (rare, but serious when it occurs)
  • Allergic reaction to numbing medicine or other components
  • Nerve irritation from the needle
  • No benefit. The treatment may simply not work for you.

Additional considerations apply to bone marrow collection (hip soreness, bruising, and rarely more serious complications) and IV infusion (vein irritation and infusion reactions).

There are also quality and regulatory risks when treatment is provided without proper oversight. The FDA has issued public warnings about clinics offering unapproved products and has reported serious adverse events in some cases. Read our stem cell therapy safety guide, our article on side effects like swelling, pain, or infection, and our honest look at the downsides of stem cell therapy.

Stem Cell Therapy in Florida: What Does the Law Say?

Florida passed a law, effective July 1, 2025, that allows physicians to offer certain stem cell therapies the FDA has not approved, but only within orthopedics, wound care, and pain management, and only within the physician’s scope of practice. The law adds requirements for product sourcing, consent, and advertising.

Here is a plain-language summary of what reporting and legal analysis say about the Florida law (SB 1768):

  • Who: physicians acting within their scope of practice.
  • What conditions: orthopedic conditions, wound care, and pain management.
  • Product sourcing: cells must be retrieved, manufactured, and stored in an FDA-registered facility that is certified or accredited by designated organizations, and must follow current good manufacturing practices.
  • Consent: the patient must sign a consent form that describes potential benefits and risks.
  • Advertising: marketing must state that the physician performs stem cell therapies not yet approved by the FDA.

There is an important caveat. Legal analysts note that the state law sits alongside federal law, and the FDA still regulates these products. Holland & Knight’s analysis, for example, describes the federal framework as still requiring approval for marketing these products for conditions such as pain and orthopedic problems, and says it is unclear how the FDA will respond. In other words, Florida’s law gives physicians state-level room, but it does not make these treatments FDA-approved, and it does not guarantee they work.

You can read more in the Florida Senate bill analysis, the WUSF Health News Florida report, and the Holland & Knight legal analysis. Our own breakdowns are here: Florida approves MSC stem cell use for orthopedic conditions and Florida’s new stem cell law, with CEO Greice Murphy.

What this means for you as a Florida patient

  • Ask where the cells come from and whether the facility is FDA-registered and accredited.
  • Look for the required notice that the physician performs treatments not yet approved by the FDA.
  • Confirm your physician’s Florida license using the Florida Department of Health’s practitioner lookup.
  • Expect a signed consent form that explains benefits and risks.
  • Be cautious of out-of-state or overseas travel for treatment. Compare options in our guide to overseas vs. U.S. stem cell treatments.

Stem cell therapy in Miami and South Florida

Miami Stem Cell is a South Miami regenerative medicine clinic at 6262 Sunset Drive, Suite 400, South Miami, FL 33143. Our website reports 16 years of experience and more than 8,500 procedures performed. Whether you are in Miami, Coral Gables, Kendall, Pinecrest, Key Biscayne, or elsewhere in Florida, you can learn more through our local pages on stem cell therapy in South Miami, stem cell therapy in Key Biscayne, stem cell injections near Miami, stem cell therapy for knees in Florida, and orthopedic regenerative medicine in Miami. If you are coming from another part of the state, ask the team about scheduling that fits your travel.

Ready to talk to a Florida physician? Book your free consultation or call (305) 598-7777.

What Does the FDA Say About Stem Cell Procedures?

The U.S. Food and Drug Administration states that, currently, the only stem cell products approved for use in the United States are blood-forming stem cells derived from umbilical cord blood. These are used for specific blood and immune conditions, not for joint pain. The agency also says exosome products are regulated and that there are currently no FDA-approved exosome products. It further states that unapproved regenerative products, whether from your own body or another person’s, require FDA approval to be marketed to consumers.

Read the agency’s own statements in its Consumer Alert on regenerative medicine products and its patient and consumer information page.

What does this mean for you? Treat any stem cell procedure as something to discuss carefully with a licensed physician, ask questions about, and weigh against alternatives. It does not mean the field has no promise. It means the evidence and the rules are still developing. For more on the legal picture, see our guide to whether stem cell therapy is legal in the U.S..

What Does the Research Say?

Research on mesenchymal stem cells for osteoarthritis, particularly in the knee, has grown quickly. A 2025 review of systematic reviews found reported improvements in pain with satisfactory safety, while stating that more research is needed before it can be considered a definitive treatment. A meta-analysis of randomized controlled trials in the Journal of Orthopaedic Surgery and Research found that a single intra-articular MSC injection was associated with improved outcomes at 12 months, and that doses of 25 million cells or fewer appeared effective, with higher doses not showing additional benefit. A more recent systematic review and meta-analysis in Frontiers in Cell and Developmental Biology looked at pain and functional outcomes across randomized trials of MSC therapy for osteoarthritis.

Studies differ in cell source, dose, method, and follow-up time, and scientists continue to debate how much improvement may relate to placebo-type effects. So the picture is encouraging but not settled. To follow ongoing studies, search ClinicalTrials.gov or read our overview of mesenchymal stem cell clinical trials.

How Much Does the Procedure Cost, and Is It Covered by Insurance?

Costs depend on the type of treatment, the number of areas treated, and the facility. Orthopedic regenerative treatments are generally not covered by standard health insurance, so many patients pay out of pocket.

For a realistic idea, see our guides on the average cost of stem cell therapy, stem cell therapy costs in Florida, and whether insurance covers stem cell injections.

Two practical tips:

  • Ask what is included. Does the price cover imaging, the procedure, follow-up visits, and any repeat session?
  • Be wary of quotes given before an exam. A fair price comes after the clinic knows what you need.

Want a clear quote for your situation? Book a free consultation and ask the team what your plan would include.

What Should You Ask Any Florida Stem Cell Clinic?

Walking in with a list protects you. Consider asking:

  1. What exactly will be injected, and where does it come from?
  2. Is the facility that supplies it FDA-registered and accredited?
  3. What is its regulatory status for my condition?
  4. How is it prepared, and who prepares it?
  5. How do you guide the needle to the right spot?
  6. What are the risks, and what happens if something goes wrong?
  7. How many treatments might I need, and what does each cost?
  8. What results can I realistically expect, and how do you measure them?
  9. What are my alternatives, including non-regenerative ones?
  10. What aftercare and follow-up are included?
  11. Can I speak with the physician who will perform the procedure?

Our complete list of questions to ask before stem cell therapy goes deeper, and our guide on how to choose a stem cell therapy treatment center explains what to look for. The nonprofit International Society for Stem Cell Research also publishes a patient resource, A Closer Look at Stem Cells, that helps you evaluate any clinic’s claims.

Red flags: guaranteed results, one treatment promised for many unrelated conditions, no exam or imaging before a recommendation, high-pressure sales, vague answers about where the cells come from, no required notice about FDA status, and reliance mostly on testimonials.

Is This Procedure Right for Me? A Quick Self-Check

This is not a diagnosis, but if you can answer yes to several of these, a consultation is a reasonable next step.

  • Has your joint or soft-tissue pain lasted for months?
  • Have physical therapy, medications, or other injections not given you enough relief?
  • Are you hoping to delay or avoid surgery, or is surgery not an option for you?
  • Are you medically stable, with no active infection?
  • Do you understand that results are not guaranteed and develop gradually?
  • Are you willing to follow aftercare and rehab instructions?

If you answered yes to most of these, book a free 15-minute consultation. If you are not sure, that is exactly what the call is for. You can also reach us through our contact page.

Frequently Asked Questions

What is the stem cell therapy procedure?

It is an in-office treatment in which a physician delivers cells, or the signals those cells release, into a joint, tissue, or vein to support healing and reduce inflammation. It follows a consultation, imaging, and a personalized plan, and it is followed by recovery and follow-up.

How long does the stem cell procedure take?

A simple joint injection often takes under an hour in total, with the injection itself taking minutes. Bone marrow collection or an IV infusion can extend the visit to one to a few hours.

Is stem cell therapy painful?

Most people describe modest, short-lived discomfort because the area is usually numbed. A bone marrow collection can feel more intense, and mild soreness afterward is common.

Do I need anesthesia or sedation?

Many injections use only a local numbing medicine. More involved procedures may use additional comfort measures. Ask your provider what applies to you.

Can I drive myself home?

Often yes after a simple joint injection, but you may be advised not to drive after a hip or spine injection or any treatment involving sedation. Arrange a ride if you are unsure.

How long is the recovery?

Many people resume light daily activity fairly quickly, while strenuous activity is limited for a period set by your physician. Results develop gradually over weeks to months. See our recovery timeline.

Will I need more than one treatment?

Some people do. It depends on your condition, your response, and your physician’s recommendation. Ask upfront how many sessions might be suggested and what each costs.

Where do the stem cells come from?

They may come from your own body, such as bone marrow, or from donated tissue such as umbilical cord tissue, depending on the treatment. Ask your provider to explain the source and how the product is processed. Read more in our comparison of cell sources.

Is stem cell therapy legal in Florida?

Florida law, effective July 1, 2025, allows physicians to offer certain unapproved stem cell therapies for orthopedics, wound care, and pain management within their scope of practice, with requirements for sourcing, signed consent, and advertising notices. Federal FDA rules still apply, and the therapies remain unapproved. See the Florida law section above.

Is stem cell therapy FDA-approved?

The FDA currently lists only cord blood–derived blood-forming stem cell products as approved stem cell products, and these are not approved for joint pain. It also states there are no FDA-approved exosome products. Review the agency’s Consumer Alert.

Is stem cell therapy covered by insurance?

Usually not for orthopedic conditions. Confirm with your insurer, and read our insurance guide.

What are the risks?

Possible risks include pain, swelling, bleeding, infection, allergic reaction, nerve irritation, and the chance that the treatment does not help. See our safety guide.

Is stem cell therapy better than a cortisone shot?

They work differently and serve different goals, and neither is automatically better. Our article on stem cell therapy vs. cortisone shots compares them.

The Bottom Line

The stem cell therapy procedure is usually less dramatic than people imagine: a careful consultation and diagnosis, a clear plan, simple preparation, a short in-office injection or infusion, and a recovery period while results develop gradually.

What matters most is not the needle. It is everything around it: an accurate diagnosis, an honest conversation about evidence and regulation, a provider who tells you where the product comes from and follows Florida’s requirements, realistic expectations, and a plan for afterward.

If you would like to talk through what the procedure would look like for you, our team is happy to help. You can meet Dr. Eric Weiss and the team, and learn about our approach to joint regeneration and pain management.

Take the next step

Book your free 15-minute consultation, or call (305) 598-7777. Miami Stem Cell, 6262 Sunset Drive, Suite 400, South Miami, FL 33143. During your free call we will discuss your condition and goals, explain which therapies may be appropriate, answer your questions about safety, timeline, and cost, and tell you honestly whether you are a candidate.

Medical disclaimer: This article is for general education and is not medical advice. Stem cell and other regenerative products discussed here have not been approved by the FDA for the treatment of joint pain or the other conditions mentioned. Procedures, timing, and aftercare vary by provider and patient. Whether any treatment is appropriate for you must be decided with a licensed physician after a personal evaluation.

 

About the Author

Greice Murphy

Healthcare Executive & CEO at Miami Stem Cell®

Healthcare executive & founder of Miami Stem Cell®, transforming regenerative medicine and autism care with innovative stem cell treatments.

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