Made Scientific to Manufacture NOVAKnee for Columbia University's Cell Therapy Program

Created at 1 Jun · 14:34 UTC1 source↑ Market-relevant

IN SHORT

Made Scientific will manufacture implants for Columbia University's NOVAKnee program, a first-in-class living biologic total knee replacement. This collaboration supports an ARPA-H-funded initiative to develop stem cell therapy implants for a Phase I clinical trial under FDA oversight.

Who's Involved

Made Scientific, Inc.

Clinical- and commercial-stage cell therapy contract development manufacturer

Columbia University

Developing the NOVAKnee program

ARPA-H

Funding the program for stem cell therapy implants

FDA

Overseeing the Phase I clinical trial

Key facts

Made Scientific selected as manufacturer for Columbia University's NOVAKnee program.
NOVAKnee is a first-in-class living biologic total knee replacement.
The program involves autologous and allogeneic cell therapy implants.
The initiative is funded by ARPA-H and aims for a Phase I clinical trial.
The trial will be conducted under FDA oversight.

This development marks a significant step in regenerative medicine for orthopedic treatments. The NOVAKnee program aims to create living biologic implants using stem cell therapy, potentially offering a new approach to total knee replacement. Made Scientific's role as a contract manufacturer is crucial for advancing this innovative therapy towards clinical trials.

↳ Why This Matters

FREQUENTLY ASKED

The NOVAKnee program is developing a first-in-class living biologic total knee replacement using autologous and allogeneic stem cell therapy implants.

Made Scientific, Inc., a cell therapy contract development and manufacturing organization, has been selected as the manufacturer.

The program is supported by funding from ARPA-H (Advanced Research Projects Agency for Health).

The next step is to proceed with a Phase I clinical trial, which will be conducted under the oversight of the U.S. Food and Drug Administration (FDA).

Key facts

Made Scientific selected as manufacturer for Columbia University's NOVAKnee program.

NOVAKnee is a first-in-class living biologic total knee replacement.

The program involves autologous and allogeneic cell therapy implants.

The initiative is funded by ARPA-H and aims for a Phase I clinical trial.

The trial will be conducted under FDA oversight.

Made Scientific to Manufacture NOVAKnee for Columbia University's Cell Therapy Program

PiQ Daily

Key facts

Made Scientific to Manufacture NOVAKnee for Columbia University's Cell Therapy Program

PiQ Daily

Key facts

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