Key Milestones in

Cell Therapy Development

Cell therapies have come a long way since Paul Niehans, one of many men proclaimed to
be the “Father of Cell Therapy”, made his initial discoveries in 1931. Over the last 90 years,
these groundbreaking therapies have experienced many advances and pitfalls, but enough
breakthroughs have occurred for the U.S. FDA to approve over 20 cell therapies in the last
decade. These approved therapies treat a wide variety of conditions by introducing new,
healthy cells into a patient’s body to replace diseased or dysfunctional cells.

The story may or may not begin with Dr. Niehans, a Swiss surgeon, but it is a good starting
point for our timeline. Read on to find out about more milestones in cellular therapy
development, including the first FDA-approved personalized immunotherapy, the creation of
murine models, stem cell COVID-19 treatments, and more.

Swiss surgeon Paul Niehans develops a

form of cell therapy called the “Niehans
method,” or fresh cell therapy. This
method involved intramuscular or
subdermal injection of fresh embryonic
animal cells. Now, many consider him
the “Father of Cell Therapy.”
1931
The first transfusion of human bone
marrow was given to a patient with
aplastic anemia. After World War II,
researchers worked to restore bone
marrow function in aplasia patients due
to radiation exposure. After a decade
of work, they were able to show that
aplasia could be overcome by
bone marrow treatment in mice.

While studying for his Ph.D. at the 1939

University of London, immunologist
Jacques Miller discovers that T cells are
developed within the thymus gland.
Many consider this event as the
origin of T cell discovery.
Robert Alan Good led a team from
1961 the University of Minnesota that
conducted the first bone marrow
transplant. The procedure
corrected an immune deficiency
in a five-month-old boy
by infusing bone
marrow extracted
from his sister.
Stanfield Roger from Oak Ridge
National Laboratory proposes that
1968
“good DNA” can be used to
replace ineffective DNA in people with
genetic disorders while researching
the properties of the
Shope papilloma
virus.

1970
2007 Nobel Prize winner Martin Evans
and Matt Kauffman identify, isolate, and
successfully culture embryonic stem
cells (ES) cells using mouse blastocysts.
This discovery facilitated the creation of
murine genetic model organisms.

MIT postdoctoral student Michel

Sadelain begins using newly
1981
developed genetic engineering
tools, specifically retroviral vectors,
to introduce genes into T cells. His
research aims to produce more robust
therapies to fight cancer.

1992 MSK researchers engineer CAR T cells

Kyoto University researchers Kazutoshi
Takahashi and Shinya Yamanaka
identify a new type of stem cell called
induced pluripotent stem cells (iPSCs).
Since their initial discovery, these cells
have greatly expanded the field and
have been used to treat diseases like
type 1 diabetes, Parkinson’s, and spinal
cord injuries.
to target a prostate cancer antigen.
Since second-generation CARs T
cells can survive, proliferate, and
kill prostate cancer cells in the lab,
researchers recognize the feasibility
of CAR T cell therapy.
2002
2006
Dendreon’s flagship product
PROVENGE® (sipuleucel-T) was the
first FDA-approved immunotherapy
made from a patient’s immune cells.

MSK physician-scientist Prasad

Adusumilli publishes results on CAR-
2013
Ts built to recognize an antigen on
solid tumors called mesothelin. Since
they don’t make CD19, solid tumors
require unconventional
approaches.

2014

Dendreon’s immunotherapy targeting

2015 cancer is withdrawn after two years

on the market by the manufacturer
The FDA approves Tisagenlecleucel for “commercial” reasons.
(Kymriah™), a form of CD19-directed
CAR T-cell therapy for treating relapsed,
refractory acute lymphoblastic
leukemia in children
and young adults.
2017
Breyanzi from Bristol Myers Squibb
became the third FDA-approved
autologous CAR-T therapy to treat
Feb. adult patients with relapsed or
refractory large B-cell lymphoma after
Lang et al. report the first stem cell
treatment of COVID-19. Seven
2021 two or more lines of systemic therapy.
patients infected with SARS-CoV-2
improved their functional outcomes
and promoted rehabilitation after
receiving intravenous,
clinical-grade MSCs.
Jun. Four women and one man, aged 18 to
24, receive transfusions of CAR T cells
2021 to treat severe lupus. The treatment
drives the disease into remission for all
five patients, raising researchers’
hopes for tackling other
auto-immune conditions
like rheumatoid
Sept. arthritis and MS.

2022

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