Vivix Biologics already offering their allograft injection for DDD

[RCRegenGuy]

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An allograft injection already being offered at some clinics in the US? Any thoughts on this particular treatment? Some good data so far (& safe).

VAST Clinical Trial: Safely Supplementing Tissue Lost to Degenerative Disc Disease - PMC

The function of the intervertebral disc is structural. Loss of tissue alters biomechanics, leads to subsequent disc degeneration, and is attributable to discogenic pain. A viable structural allograft was delivered into degenerate discs to determine ...

www.ncbi.nlm.nih.gov

 

[Orin]

That is a rather effective placebo, and the treatment itself looks pretty good too.

 

[SommeRiver]

I work with one of those guys and know another one...

 

[DoYouEvenLiftBro]

I work with one of those guys and know another one...

will you implement it in your practice?

 

[SommeRiver]

Doubtful, no.

 

[Espn123]

I work with one of those guys and know

I work with one of those guys and know another one...

Is this positive, negative, or just an fyi? 🙂

 

[SommeRiver]

None of the above. Just saw the names and thought, "Looky here..."

 

[BobBarker]

The discs don’t look better on the first MRI.

 

[pmrmd]

The subjects were given the treatment based on MRI but it doesn’t say other diagnoses were ruled out first. It’s not like it’s rare to have concurrent z-joint pain with modic changes on imaging.

Pre/post MRI pics are unimpressive.

 

[epidural man]

Not sure how they will get past the FDA crack down on 361 products. I guess they can use it until May 2021 (FDA keeps extending the deadline).

 

[Espn123]

Not sure how they will get past the FDA crack down on 361 products. I guess they can use it until May 2021 (FDA keeps extending the deadline).

Can you elaborate/educate on this? I’d like to learn more

 

[epidural man]

Can you elaborate/educate on this? I’d like to learn more

Sure - I can a little.

To market a HCP/T 361 product takes a single form and is super easy. It is for homologous use.

An official definition of homologous use as it pertains to HCT/Ps is found in 21 CFR 1271.3(c):

“means the repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor.”

To market something other than 361 (like a drug, biologic, etc) takes phase I-III trials (very expensive and time consuming). To market for 361 takes nothing but a single form filled out and submitted to the FDA.

Naturally, companies want to sell and be regulated under 361. So every company CLAIMED their product was a HCP/T 361 product. The FDA became very concerned and basically started going after companies that clearly were not using homologous use products. In 2017, they put out a few documents that very clearly defined what was NOT homologous use - and all amniotic tissue products fit under that category. They also gave companies until NOV 2020 to get an IND in place in order to continue to market their product. That is the deadline that was extended.

Here is a nice little info article about this.

FDA Announces Six-Month Extension of Enforcement Discretion Policy for Certain Regenerative Medicine Products

FDA announced this week that it intends to extend its enforcement discretion policy regarding invest ...

www.cov.com