Search Results for: amniotic

Weekly stem cell reads: AI-human hybrids, eye drops, Cell Surgical Network case delay

Seven_of_nine, Borg, stem cell

Before we jump into our weekly stem cell and regenerative medicine reads, check out my new video on our stem cell YouTube channel below on robots with human brain tissue. In that video, I discuss the integration of computers and other technologies into the human body. When involving the brain, these technologies are often called […]

Weekly stem cell reads: AI-human hybrids, eye drops, Cell Surgical Network case delay Read More »

Key Mayo Clinic stem cell webpage is overexuberant & outdated

The Mayo Clinic.

The Mayo Clinic does some great research on stem cells and regenerative medicine. However, at times I’ve felt that a few Mayo researchers are overexuberant. This mainly relates to certain not-yet-proven stem cell and related offerings. Fitting with that perception, the Mayo website also has some inaccurate stem cell content that leans toward overstating things.

Key Mayo Clinic stem cell webpage is overexuberant & outdated Read More »

Weekly reads: MiMedX & Kimera Labs FDA warnings, NYT on Bryan Johnson, MUSE cell trial

AXIOFILL, MiMedx

Placental biologics firm MiMedx and exosome company Kimera Labs both recently received FDA warning letters. The letter to MiMedx was related to its placental biologics products and procedures. The new warning to Kimera Labs was about its exosome products and an amniotic product. Let’s compare these letters starting with the one to MiMedX. MiMedx warning letter

Weekly reads: MiMedX & Kimera Labs FDA warnings, NYT on Bryan Johnson, MUSE cell trial Read More »

20 stem cell & regenerative medicine predictions for 2024

Stem cell, crystal ball, predictions

Each year I make predictions for the stem cell and regenerative medicine field for the following year. Today’s prediction post is focused on what to expect in 2024. You can also see my stem cell predictions for 2023 and my grades on how I did. I also have made a video version of these predictions so please

20 stem cell & regenerative medicine predictions for 2024 Read More »

FDA warns more perinatal cell therapy firms: RenatiLabs & Cell Genuity

Dr. Leonid Macheret, FDA warning

Starting last year the FDA has focused much of its cell therapy oversight resources on birth-related firms, including both clinics and suppliers. The latest warnings went to RenatiLabs & Cell Genuity. Warnings to unproven perinatal cell therapy firms Earlier this summer the agency warned Regenative Labs. There have been quite a few letters to others in this

FDA warns more perinatal cell therapy firms: RenatiLabs & Cell Genuity Read More »

Stem cell therapy cost in 2024: data & analysis

stem cell therapy cost

How much does stem cell therapy cost in 2024? How have prices changed? To authoritatively answer these questions now we need data from the present and past along with expert perspectives. Some surprises come up in this new analysis. In this article Intro  | Stem Cell Therapy Cost: $10,000-$20,000 | Why do stem cells cost so much?

Stem cell therapy cost in 2024: data & analysis Read More »

Weekly reads: reprogramming hearing loss, heart disease, eye drops, sickle cell

Regener-Eyes, eye drops

It’s mostly been a week of good and encouraging news in the regenerative medicine space including with gene therapies maybe with the exception of some eye drops warnings (more below). There’s realistic hope for an approved sickle cell disease soon. I also see some long-term positive news on hearing loss research. Hematopoietic stem cell transplant

Weekly reads: reprogramming hearing loss, heart disease, eye drops, sickle cell Read More »

Weekly reads: Sarepta, epigenomics, FDA on eyedrops

Sarepa CEO interview.

The biotech Sarepta has had a complicated go of it with the FDA sometimes related to their Duchenne muscular dystrophy (DMD) gene therapy efforts. In late 2016 I wrote about how there was some controversy as the FDA approved the Sarepta drug eteplirsen (Exondys 51) also for DMD, going against an advisory panel that had

Weekly reads: Sarepta, epigenomics, FDA on eyedrops Read More »

Does Medicare cover stem cell therapy? Mostly no & it’s poised to recoup tens of millions

Regenative labs, does Medicare cover stem cell therapy?

Does Medicare cover stem cell therapy? Readers of The Niche have regularly asked this question. They’re curious about insurance coverage too. The answer is “no” in almost every case, with some notable exceptions I’ll get to at the end of the post. Still, clinics appear to have already been charging Medicare for what collectively adds

Does Medicare cover stem cell therapy? Mostly no & it’s poised to recoup tens of millions Read More »

Fact-checking exosome therapy: costs, risks, & lack of data

model of an exosome, exosome therapy

Exosome therapy is a still-experimental cell therapy approach aimed at treating specific diseases using secretions from cells. It’s novel since most attention on cell therapies has been given to using the actual cells themselves. In addition, this approach is a newer idea than using cells as the drug to treat diseases. Interestingly, the term “cell

Fact-checking exosome therapy: costs, risks, & lack of data Read More »