Stem Cells and Cell-Based Products

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• Clinical Trials for Stem Cell Products

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Stem Cells and Cell-Based Products

• Stem cells are undifferentiated cells of the
  human body that are able to differentiate into
  any cell of an organism and have the ability of
  self-renewal. Based on the cell type/tissue of
  origin, stem cells are classified as Somatic Stem
  Cells and Pluripotent Stem Cells.
• Clinical trials undertaken with Stem Cell and
  Cell based Product come under the ambit of
  Central Drugs Standard Control Organisation
  (CDSCO). All sponsors /clinics/hospitals who
  intend to develop and utilise stem cells
  therapies have to meet the rigorous standards
  prescribed for clinical trials.

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• Preclinical testing
• Preclinical testing would require prior approvals
  from IEC, Institutional Animal Ethics Committee
  (small animals), and Committee for the Purpose of
  Control and Supervision of Experiments on Animals
  (large/nonhuman primates).

• Clinical Trials Involving Stem Cells
• Clinical trials undertaken with Stem Cell and
  Cell based Product come under the ambit of
  Central Drugs Standard Control Organisation
  (CDSCO). All sponsors /clinics/hospitals who
  intend to develop and utilise stem cells
  therapies have to meet the rigorous standards
  prescribed for clinical trials.

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Procurement and Exchange of Stem Cells Products
and Derivatives

• The procurement of Stem Cells Products is
  strictly regulated to prevent misuse and
  commercialization of unproven stem-cell therapy.
  The major provisions related to procurement of
  Stem Cells Products are as follows
• Import of any type of Stem Cells Products
  mandates license from CDSCO as per the
  established regulations.
• Clinical trials sponsored by multinationals,
  employing the cell products developed outside
  India, should have clearances from the regulatory
  authorities of the country of the origin and
  shall need prior approval from the CDSCO
  following clearance from both IC-SCR and IEC of
  the trial site.
• Import of stem-cell lines for clinical trials and
  originating oversees requires import clearance
  from the CDSCO. For export of indigenously
  developed cell lines, IEC and IC-SCR clearances
  must be obtained and submitted along with the
  Material Transfer Agreement during the review of
  such research proposals.