This trial is no longer recruiting

Recruitment for this study has ended, so applications are closed. You can still read the trial details, or browse similar trials that are currently recruiting.

Not recruiting
Phase 1

IMS001

Sponsor:

ImStem Biotechnology

Code:

NCT04956744

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

IMS001

Study Details

Brief summary:

This is a Phase 1 study of IMS001, given as a single dose to subjects with Multiple Sclerosis who experience inadequate response and/or intolerability to disease modifying treatments. IMS001 is a human embryonic cell derived (hESC) mesenchymal stem cell (MSC). MSCs have the potential to modulate disease course.

Conditions

Multiple Sclerosis

Study ID

NCT04956744

Start date

Aug 31, 2021

Status verified date

Sep, 2023

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Provides signed and dated informed consent in accordance with local regulations.
  • 18 to 65 years of age.
  • Diagnosis of MS.
  • Has had an inadequate response DMTs.
  • EDSS within protocol parameters.
  • Able and willing to undergo MRIs.
  • Must be clinically stable for 1 month prior to Day 1.

Exclusion Criteria:

  • Has a known or suspected hypersensitivity to human serum albumin, diphenhydramine, acetaminophen, methylprednisolone, or any of the components of IMS001.
  • Has history of excluded medications, per protocol, prior to Day 1.
  • Has a history of neoplastic disease except for basal cell carcinoma, non-metastatic squamous cell carcinoma of the skin that has been excised with clean margins, or adequately treated in-situ carcinoma of the cervix.
  • Prior history of any other autoimmune disease, myelodysplasia, or hematologic disease.
  • Prior treatment with any allogeneic cell therapy or tissue transplant.
  • Prior history of smoking equivalent to ˃20 cumulative pack years of cigarettes.
  • Recent clinically significant infection during the Screening Phase.
  • Has any medical or psychiatric condition that would impact outcome or participation in the study.
  • Has clinically significant abnormal findings on the electrocardiogram (ECG) during the Screening Phase.
  • Has known or documented human immunodeficiency virus (HIV) infection or active Hepatitis B, or C.
  • Has an elevated liver function test abnormality during the Screening Phase.
  • Has abnormalities of blood count during the Screening Phase.
  • Has laboratory abnormalities of renal function during the Screening Phase.
  • Has other clinically significant laboratory abnormalities during Screening Phase.
  • Body weight ≥120 kg.
  • Women pregnant, breast feeding, or planning to become pregnant during the study.
  • Is unavailable for the duration of the trial, is likely to be noncompliant with the protocol, or is generally felt to be unsuitable by the principal investigator.
  • Current or recent participation in any other clinical or device trials within 3 months prior to Day 1.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Low Dose

Low dose of cells/kg of intravenous (IV) IMS001 as a single dose infusion on Day 1.

experimental: High Dose

High dose of cells/kg of intravenous (IV) IMS001 as a single dose infusion on Day 1.

experimental: Optional Dose

High dose of cells/kg of intravenous (IV) IMS001 as a single dose infusion on Day 1 and at Month 6.

Interventions

IMS001

IMS001 is a human embryonic cell derived (hESC) mesenchymal stem cell (MSC).

Primary outcome measure

  • Safety and tolerability [ Time Frame: Day 1 to Month 60 ]
  • Safety and tolerability [ Time Frame: Day 1 to Month 60 ]

Central Contacts and Locations

Central contacts

Richard Kim, MD

860-281-7836richard.kim@imstem.com

Locations

Shepherd Center

Recruiting

Atlanta, Georgia, United States, 30309

UMass Memorial Medical Center

Recruiting

Worcester, Massachusetts, United States, 01605

Rocky Mountain MS Clinic

Recruiting

Salt Lake City, Utah, United States, 84103

More Information

Sponsor

ImStem Biotechnology

Last update posted

Sep 28, 2023

Last verified

Sep, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-28. This information was provided to ClinicalTrials.gov by ImStem Biotechnology on 2023-09-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.