At Innate Healthcare Institute, we’re passionate about empowering our patients with educational resources to better themselves and adhere to our S.T.E.M philosophy. We aim to explain core concepts in stem cell science, current regulatory status, potential risks, and how we think about future clinical research, so you can make an informed decision for your health. This is not an advertisement for treatment and makes no claims of safety or effectiveness.

*These statements have not been evaluated by the FDA. Innate healthcare Institute makes no claim to diagnose, treat, cure, or prevent any disease.

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Stem Cell Medicine Innate Healthcare Institute

What Are Stem Cells?

Stem cells can self‑renew and can differentiate into other cell types. Broad families include tissue‑specific (adult) stem/stromal cells, perinatal cells (e.g., from umbilical cord/placenta), and pluripotent cells (embryonic or induced). Research explores how these cells—or the signals they release—might be used to study or someday help address disease, but translation to proven therapies is still limited for most conditions. Stem‑cell medicine with mesenchymal stromal cells (MSCs) explores how adult cells—sourced from tissues like bone marrow, fat, or umbilical cord—may signal the body to modulate inflammation and support normal repair. In the U.S., MSC uses are investigational and generally available only in FDA‑authorized research.

We believe promising science should move forward lawfully and carefully. Innate Healthcare Institute is preparing an Investigational New Drug (IND) application to evaluate a defined stem‑cell‑based approach in a controlled study. This includes:

Pre‑IND engagement with FDA and IRB oversight.
Manufacturing & quality plans (donor eligibility, characterization, sterility, and fit‑for‑purpose release testing).
A phase‑appropriate clinical protocol focused on safety and feasibility.

There is current and past research showing safety and efficacy in MSC based studies, including our own work here at Innate Healthcare Institute. This is very promising and we aim to continue advancing the field of this field of medicine with significant potential.

We are a regenerative and integrative medicine clinic providing physician led, evidence informed care. Our team is committed to rigorous safety, transparency, and whole person treatment.

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FAQs

Frequently Asked Questions

What are stem cells?

Stem cells are cells that can self‑renew (make more of themselves) and differentiate (become other cell types). Broad categories include pluripotent stem cells (embryonic and induced pluripotent cells) and tissue‑specific (“adult”) stem cells found in organs like umbilical cords, bone marrow or skin. Researchers study them to understand development, repair, and disease—most clinical uses remain limited and indication‑specific.

What are Mesenchymal Stem/Stromal Cells (MSCs) and how are they different from other stem cells?

Mesenchymal stromal/stem cells (commonly called “MSCs”) and often refered to as Medicinal Signaling Cells are non‑hematopoietic cells that can adhere to plastic in culture, display a characteristic surface‑marker profile(CD105/CD73/CD90 positive; hematopoietic markers negative), and differentiate into bone, fat, and cartilage in vitro—the classic ISCT “minimal criteria.” In people, MSCs appear to act mainly by paracrine and immunomodulatory signaling, not by becoming new tissue broadly. They differ from pluripotent cells (which can become almost any cell type) and from hematopoietic stem cells (which make blood and immune cells). MSCs can be sourced from bone marrow, adipose tissue, and perinatal tissues (e.g., umbilical cord).

How are MSCs administered?

In clinical studies, administration routes depend on the indication and remain investigational. Common research routes include intravenous (IV), intra‑articular (into a joint), intrathecal (around the spinal cord), and less commonly intramyocardial/intracoronary or local soft‑tissue injections. Each route carries route‑specific risks—for example, IV delivery can trigger blood‑compatibility reactions and pulmonary “first‑pass” trapping; intrathecal delivery has reported post‑procedure back pain/meningism in some trials. There is no single, standardized dosing or route accepted across conditions.

Are umbilical‑cord–derived MSCs (UC‑MSCs) considered safe?

Data from controlled trials suggest UC‑MSC infusions are often well tolerated under research conditions, but safety and efficacy remain under investigation and can vary by manufacturing quality, dose, and route. Reviews and meta‑analyses report mostly mild infusion reactions but also document risks (e.g., thromboembolic events, infections) and emphasize the need for standardized products and longer follow‑up.

What side effects does research show for UC‑MSCs?

Reported events vary by study and route:

Common, usually transient (especially with IV): low‑grade fever, flushing, transient blood‑pressure changes, infusion reactions.
Route‑specific: after intrathecal delivery, some trials note backache/meningism‑like symptoms; risk profile differs from IV or intra‑articular use but generally safe.
Infections: meta‑analyses of IV MSCs conclude that intravenous delivery of mesenchymal stem cells is safe for many conditions. Lippincott Journals
Thromboembolic events/clotting phenomena (rare but serious): case reports and reviews describe pulmonary embolism and blood‑compatibility reactions (often linked to tissue‑factor expression and the instant blood‑mediated inflammatory reaction, IBMIR) after intravascular cell delivery.

*These statements have not been evaluated by the FDA. Innate Healthcare Institute is a private clinic and any treatments utilizing any form of regenerative medicine is considered experimental.

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